The Journal of Bone and Joint Surgery (American). 2005;87:2133-2146.
doi:10.2106/JBJS.E.00474
© 2005 The Journal of Bone and Joint Surgery, Inc.
What's New in Hip Arthroplasty
Michael H. Huo, MD1 and
Nathan F. Gilbert, MD1
1 Department of Orthopedic Surgery, University of Texas Southwestern Medical
School, 5323 Harry Hines Boulevard, Dallas, TX 75390-8883. E-mail address for
M.H. Huo:
michael.huo{at}utsouthwestern.edu
Specialty Update has been developed in collaboration with the Council of
Musculoskeletal Specialty Societies (COMSS) of the American Academy of
Orthopaedic Surgeons.
The authors did not receive grants or outside funding in support of their
research or preparation of this manuscript. They did not receive payments or
other benefits or a commitment or agreement to provide such benefits from a
commercial entity. No commercial entity paid or directed, or agreed to pay or
direct, any benefits to any research fund, foundation, educational
institution, or other charitable or nonprofit organization with which the
authors are affiliated or associated.
IN MEMORIAM: It is with sincere regret and sadness
that we bring the news of death of two members of the Hip Society during the
past year. Dr. Carl Nelson and Dr. Marvin Meyers both were important
contributors to the mission and vision of reconstructive hip surgery.
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Introduction
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Total hip arthroplasty is one of the most clinically efficacious and
cost-effective medical interventions. Surgeons and scientists have continued
to produce a tremendous amount of research data related to clinical outcomes,
biomaterials, surgical techniques, treatment of complications, and
socioeconomic analysis. Between April 2004 and April 2005, fifty-five reports
related to total hip arthroplasty were published in The Journal of Bone
and Joint Surgery (American Volume), 140 were published in the
Journal of Arthroplasty, and sixty-eight were published in
Clinical Orthopaedics and Related Research. In addition, 190
abstracts on this topic were presented at the annual meeting of the American
Academy of Orthopaedic Surgeons, forty-two were presented at the annual
meeting of the American Association of Hip and Knee Surgeons, and eighty were
presented at the fall and spring meetings of the Hip Society. There were also
numerous abstracts and papers from the Orthopaedic Research Society and
reports in other peer-reviewed publications. We have organized this review
update into seven sections: (1) primary total hip arthroplasty (including
surface arthroplasty), (2) revision, (3) bearing surface, (4) minimal incision
surgery, (5) complications, (6) practice management, and (7) cost analysis.
Special focus is given to two of these topics: bearing surfaces and cost
analysis.
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Primary Total Hip Arthroplasty
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Fixation with Cement
Controversies exist with regard to the most optimal stem surface finish for
cement fixation. Callaghan et al. reviewed the minimum ten-year results of 574
hip replacements that had been performed by a single surgeon using stems with
three different surface finishes (5, 30, and 80 Ra). The rates of revision for
aseptic loosening were 0% (5 Ra), 2% (30 Ra), and 10.8% (80 Ra). The combined
rates of revision and radiographic failure were 0% (5 Ra), 3.6% (30 Ra), and
13% (80 Ra). The difference was significant between the 5-Ra and 80-Ra groups
(p < 0.05) and between the 30-Ra and 80 Ra-groups (p < 0.05). The
difference was not significant between the 5-Ra and 30-Ra groups. White et al.
reviewed the two to five-year results of 251 hip replacements that had been
performed by multiple surgeons using stems with four different surface
finishes (polished, matte, rough, and precoated with methylmethacrylate).
There were no differences among the four groups with regard to the clinical or
radiographic outcome. Junick et al. reviewed the results of 335 consecutive
hip replacements that had been performed by a single surgeon using a stem with
precoated matte finish. The mean duration of follow-up was 7.4 years (range,
five to eleven years). The rate of stem survival was 97.8% at ten years, with
loosening as the end point. These data were in contrast to previous reports
describing accelerated early debonding with this particular stem design.
Surface finish may be a critical factor in the durability of fixation with
cement, particularly with specific stem geometries.
Fixation without Cement
There has been little new information on the clinical outcome of cementless
hip arthroplasty. Implants with a coating of hydroxyapatite have been widely
used. It is appealing to apply other chemical or pharmacological additives to
the implant surface for the purpose of improving fixation, preventing
loosening or osteolysis, reducing infection, or delivering analgesia.
Elmengaard et al. conducted a matched-pair study in which a titanium-alloy
cylinder with a porous coating with or without growth factors (TGF-beta and
IGF-1) was placed in the femoral condyles of nine dogs. One knee received an
implant without growth factors, and the other knee received an implant with
growth factors. The drill-hole was 1.5 mm larger than the diameter of the
implant, thus leaving a gap between the implant and the bone. The implants
were inserted to allow for full-weight loading with each gait cycle. The
animals were killed at four weeks. Push-out testing demonstrated significantly
greater shear strength and energy to failure in the implants that were coated
with growth factors (p < 0.001). In addition, histomorphometric examination
of the implant-bone interface demonstrated significantly less fibrous tissue
around the implants that were coated with growth factors. That study and other
similar studies provide promise that further improvement in cementless
fixation can be realized in the clinical setting.
Resurfacing Arthroplasty
There has been a resurgence of interest in resurfacing arthroplasty. Sales
of resurfacing implants have become one of the fastest-growing segments in the
worldwide market. The use of this procedure in the United States is limited at
the present time. The clinical outcome of total surface arthroplasty has been
reported to parallel that of stem-type total hip arthroplasty. Amstutz et
al.1 reported on 400
metal-on-metal hybrid surface arthroplasties. The procedures were performed in
a high-demand population; the mean age was forty-eight years, 73% of the
patients were men, and 66% of the patients had osteoarthritis. After a mean
duration of follow-up of 3.5 years, 3% of the hips required revision to a
stem-type hip replacement. The survival rate was 94.4% at four years. Pain
relief and functional capacity were excellent in the majority of the patients.
McMinn and Daniel reported perhaps the largest single-center experience. The
overall failure rate was 0.88% (nineteen of 2167) after a mean duration of
follow-up of 5.8 years. The same authors also reported on the use of a minimal
posterior approach for the performance of 232 consecutive surface
arthroplasties. There were no significant differences in objective data such
as estimated blood loss, component position, or rehabilitation when the
results of these procedures were compared with the results of procedures
performed with use of a conventional incision.
One of the complications of surface arthroplasty is femoral neck fracture.
Mont et al. reported a high prevalence of femoral neck fractures (22%) in
their first fifty cases. With more experience, the fracture rate was reduced
to 0.4% (one hip) in the subsequent 250 consecutive cases. Amstutz, Campbell,
and Le Duff2
reported a fracture rate of 0.83% (five of 600). All five fractures were
associated with a traumatic event. However, technical factors, including
notching of the lateral cortex, out-of-axis reaming, and excessive removal of
marginal osteophytes from the femoral neck, were identified as contributing
risk factors. Beaule et
al.3 reviewed a
subset of ninety-three surface arthroplasties that had been performed in
patients younger than forty years of age. The mean duration of follow-up was
4.2 years. The authors identified thirteen hips (14%) that were considered to
be failures because of revision to a stem-type hip arthroplasty, resorption of
the femoral neck bone, or loosening. Radiographic analysis demonstrated a
valgus position as a prerequisite for optimal durability of femoral component
fixation. Silva et
al.4 analyzed hip
biomechanics in a study of consecutive surface arthroplasties and compared the
data with those from forty consecutive stem-type total hip arthroplasties. All
procedures were performed by a single surgeon. In the surface arthroplasty
group, the horizontal offset was consistently shorter in the treated hip as
compared with the normal, contralateral hip. This finding was due to valgus
positioning of the femoral component. In contrast, in the total hip
arthroplasty group, the femoral offset was generally longer in the treated hip
as compared with the contralateral, normal hip. Limb-length equalization
within 1 cm was achieved with both types of reconstruction. The authors
concluded that surface arthroplasty is less ideal in patients who have a
substantial leg-length inequality or a varus neck-shaft angle (large offset)
preoperatively.
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Revision Total Hip Arthroplasty
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The volume of revision surgery has continued to increase. Kurtz et al.
analyzed the burden of total hip revision surgery in the United States with
use of National Hospital Discharge Survey data from 1990 to 2002 and found a
60% increase. Approximately 43,000 revisions were done in 2002, accounting for
17.5% of all hip arthroplasties. Fortunately, the year-to-year revision rate
did not increase over this period. Moreover, the cause of failure leading to
revision surgery has changed. Lachiewicz and Soileau reviewed two series of
100 consecutive hip revisions that were performed by a single surgeon at a
tertiary teaching hospital. The first 100 procedures were done in the early
1990s. The second 100 procedures were done after 2000. There were distinct
differences in the indications for revision between the two groups. The
contemporary group had more isolated stem revisions (p < 0.005), more
recurrent dislocations (p < 0.001), and more problems with wear and
osteolysis (p = 0.03). Bozic et
al.5 reviewed the
results of 243 revisions that had been performed at a tertiary medical center.
The most common mode of failure leading to revision was osteolysis, followed
by loosening and recurrent dislocation.
Acetabulum
A pelvic reinforcement cage has been used most often in conjunction with
structural allograft to address major acetabular bone deficiencies. Berry et
al., in a study of eighty-one procedures that were performed with use of a
cage from 1991 to 1998, reported that 70.3% of the cages remained in situ
after a mean of 5.3 years of follow-up. The mean Harris hip score improved
from 45 to 74 points. The major reasons for cage failure were loosening or
instability (55%) and infection (45%). Cage fracture occurred in association
with 30% of the cases of loosening. Lewallen et al., in a study from the same
institution, reported on 111 hips that had been treated with a revision shell
made of tantalum from 1999 to 2001. Six hips (5.4%) required a reoperation
because of dislocation (four patients), wound hematoma (one patient), and the
need for wire removal (one patient). No shell migrated. No cup was revised for
loosening. A normal hip center was restored in 86% of the hips. Incomplete
radiolucent lines at the bone-shell interface were observed in 7% of the hips.
These surgeons also reported that they inserted a tantalum shell to bridge
major bone deficiencies and supported the shell with a pelvic reinforcement
cage in selected situations. The long-term durability of this device and
technique remains to be validated.
Femur
Allograft-prosthesis composites have been utilized for patients with
extreme femoral bone deficiencies. Hanssen et al. reported on the use of this
technique in an intussusception mode. All patients had Paprosky type-III or IV
femoral bone deficiencies. Major complications included one infection
necessitating hip disarticulation, two recurrent dislocations, two wound
hematomas, and eight intraoperative femoral fractures. The mean duration of
follow-up was 5.1 years. The mean Harris hip score improved from 48 to 72
points. Of the twenty-six patients, twenty-four achieved complete union
clinically and radiologically at a mean 5.5 months after surgery. This
technique serves as an alternative to the use of either large-diameter
extensively coated cylindrical stems or modular tapered stems for these
complex reconstructions.
Another option for addressing massive femoral bone loss is to use a
megaprosthesis originally designed for reconstruction following tumor
resection. Parvizi and
Sim6 outlined the
indications, surgical technique, and contraindications for this technique.
They reviewed the clinical results in six series published from 1981 to 1995.
These series included 133 hips with a mean duration of follow-up ranging from
four to 11.1 years. The overall survival rate ranged from 58% to 90%. The
major complications were dislocation (prevalence, 20% to 50%), fracture
(prevalence, 50%), leg-length inequality (prevalence, 50%), and infection
(prevalence, 16%). Berend et
al.7 reported the
results for fifty-nine patients who had had a reconstruction with use of a
total femoral implant for salvage of total hip arthroplasty failure. These
procedures were done over a period of thirteen years. The mean age at the time
of total femoral arthroplasty was seventy-four years. The mean duration of
follow-up was nearly five years (range, one to thirteen years). There was
significant improvement in pain and function (p < 0.05). The survival rate
with aseptic revision as the end point was 75% at ten years. Complications
included infection (prevalence, 14%) and dislocation (prevalence, 12%). One
intriguing subset comprised fourteen patients who had had a previous
infection. Reinfection occurred in only one of these patients. The high rate
of dislocation may be reduced with use of newer constrained liners and
soft-tissue reconstruction around the prostheses. The rate of infection may be
reduced with use of suppressive antibiotic therapy and antibiotic-impregnated
bone cement.
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Bearing Surface
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Wear at the bearing surface is one of the most important areas of research
related to total hip arthroplasty. This is reflected by the fact that wear and
osteolysis are among the most frequent causes of revision surgery. Substantial
controversies remain with regard to which type of bearing surface is the most
durable. Several recent reports have focused on potential problems with
alternative bearing surfaces that have been introduced into wide clinical
application over the past five years: highly cross-linked polyethylene,
ceramic, and metal-on-metal couplings.
Highly Cross-Linked Polyethylene
The principal aim of highly cross-linked polyethylene is to reduce surface
wear and oxidation. At the present time, six different types of highly
cross-linked polyethylene are commercially available in the United States.
They all differ in terms of the radiation dose, radiation technique, thermal
treatment to remove free radicals, and terminal sterilization technique. Such
differences in manufacturing can influence the wear characteristics and
mechanical properties of a given material. Despite some differences,
significant wear reduction in hip simulators has been shown in association
with all of these new materials. Data from recent laboratory tests and
clinical retrieval analysis studies have demonstrated a greater amount of free
radicals in material that was made with post-irradiation annealing (heating
below the melting temperature) compared with materials that were melted.
Greater amounts of free radicals also were found in the material following
artificial aging (5 atmospheres of oxygen at 70°C to 80°C for two
weeks) and real-time aging (in an aqueous bath at 40°C) and in retrieved
liners after in vivo usage.
Post-irradiation melting reduces the crystallinity of the polyethylene,
whereas annealing does not. This reduced crystallinity results in a reduced
modulus of elasticity and yield strength. The potential clinical relevance is
related to reduction in ultimate tensile strength, in chain mobility and
energy absorption, and in fatigue crack propagation. Bradford et
al.8 reported data
on twenty-four liners: twenty-one highly cross-linked polyethylene liners that
were retrieved after a mean of ten months of in vivo, one unused (control)
highly cross-linked polyethylene liner, and two control non-cross-linked
(ethylene oxide-sterilized) polyethylene liners. This particular highly
cross-linked polyethylene (Durasul; Zimmer, Warsaw, Indiana) was made with a
radiation dose of 9.5 Mrad at 120°C with use of electron-beam radiation,
remelted at 150°C, and sterilized with use of ethylene oxide. All of the
retrieved components demonstrated some evidence of wear, including scratching
(prevalence, 96%), pitting (prevalence, 79%), abrasion (prevalence, 71%),
surface cracks (prevalence, 67%), deformation (prevalence, 8%), and
delamination (prevalence, 4%). Scanning electron microscopy demonstrated a
consistent pattern of surface-crack damage parallel to and perpendicular to
the machining marks. These surface cracks may have progressed to further
subsurface cracking and fatigue wear with longer in vivo usage. No data on
mechanical testing of these explants were provided. The findings of that study
were different from previously reported in vitro testing data on the same
material. These findings following short-term in vivo usage may not
necessarily correlate with long-term wear behavior or with the in vivo
behavior of other highly cross-linked polyethylenes. The authors recommended a
need for modifications in hip simulator testing protocols in order to more
accurately reflect the early in vivo wear characteristics that they noted.
Shen and
McKellop9 evaluated
the wear characteristics of highly cross-linked polyethylene cups made with
two novel methods. The principal aim of both methods was to produce
cross-linking in only the superficial layer in the hope of preserving the
mechanical properties of the material bulk against scratch and crack
propagation. With the first method, low-energy electron beams were used to
create the cross-linking, which was followed by annealing at 100°C for
three to six days to reduce residual free radicals. With the second method,
chemical cross-linking was produced by mixing polyethylene powder with 1%
weight peroxide under compression of 6.9 MPa at 170°C. Both methods
produced cross-linking to a depth of 2 to 3 mm from the surface. Simulator
testing against smooth femoral heads demonstrated mean wear rates for the
electron beam-irradiated materials ranging from 25.6 mm3/million
cycles (5 Mrad) to 9.2 mm3/million cycles (15 Mrad). The mean wear
rate for the chemically cross-linked material was 17.1 mm3/million
cycles, which most closely resembled that of the material irradiated with
10-Mrad (15.6 mm3/million cycles). The wear rates for all materials
increased dramatically (range, fivefold to ninefold) when testing involved
articulation against roughened femoral heads. The wear rates, however,
returned to earlier values when testing was changed to articulation against
smooth heads again. One of the most important findings of that study was that
cross-linking gradually decreased from the surface layer to the depth of 2 to
3 mm. It is hoped that this gradual transition will minimize the potential for
an abrupt interface transition leading to delamination.
Harris reported on the improved mechanical properties of two new forms of
highly cross-linked polyethylene. One material (cold-irradiated, mechanically
annealed polyethylene) was manufactured by cold irradiation (10 Mrad) followed
by compression at 130°C and annealing at 136°C. The second material
was prepared by soaking irradiated polyethylene (10 Mrad) in vitamin E at
110°C. No free radicals were detected in the cold-irradiated mechanically
annealed material. Free radicals were detected in the vitamin-E-soaked
material. Both materials showed no oxidation following accelerated aging. The
pin-on-disc wear rates for both materials were similar to those for untreated
polyethylene irradiated at a dose of 10 Mrad. The fatigue strength, ultimate
tensile strength, and yield strength were significantly higher for both newer
materials than for the untreated polyethylene irradiated at a dose of 10 Mrad
(p < 0.01). Essner et al. reported data on the wear and tensile properties
of highly cross-linked polyethylene made with another novel method of
sequential irradiation and annealing. This process involves irradiation at a
dose of 3 Mrad followed by annealing at 130°C for eight hours. This is
repeated three times sequentially; thus, the total irradiation dose is 9 Mrad.
Sterilization was done with use of ethylene oxide. Free radical concentration
was 14 x 1014 spins/g, compared with 1550 x
1014 spins/g for the conventional polyethylene (irradiated at a
dose of 3 Mrad irradiation in nitrogen). Wear testing was conducted with use
of two sets of liners with thicknesses of 7.5 and 4.9 mm, which articulated
against 32-mm heads for 5 million cycles. Volumetric wear was 1.3 ± 0.7
mm3/million cycles for the 7.5-mm liners and 1.5 ± 0.9
mm3/million cycles for the 4.9-mm liners (p = 0.085). These wear
measurements were significantly lower when compared with those associated with
conventional non-cross-linked polyethylene (p < 0.0001) and with an
earlier-generation highly cross-linked polyethylene (p = 0.02). Mechanical
testing demonstrated no difference in yield strength or ultimate tensile
strength between the sequential cross-linked and conventional polyethylenes.
There was no difference between the polyethylenes with regard to
crystallinity. Moreover, there was no alteration of the mechanical properties
following artificial aging. These newer highly cross-linked materials have not
yet been introduced into clinical use. Their efficacy in the clinical setting
remains to be validated, particularly with some retrieval analysis in the
future. The in vivo wear behavior may be different from the results of in
vitro testing as demonstrated by Bradford et
al.8.
Clinical data have continued to validate superior wear rates in hips with
highly cross-linked polyethylene. Krushell and Fingeroth reported on a
case-controlled series of eighty hips, forty of which were treated with
conventional polyethylene liners and forty of which were treated with highly
cross-linked polyethylene liners. The femoral head size was 28 mm.
Radiographic wear measurements were made at a mean of four years. There was a
59% reduction in femoral head penetration in the highly cross-linked
polyethylene group (0.05 mm/year compared with 0.12 mm/year, p < 0.001).
Wear-rate analysis is sensitive to the radiographic measurement technique.
Bragdon et al. compared the Martell method with the radiostereometry
technique. Measurements were made for forty-five hips at one, two, and five
years after surgery. After accounting for the initial bedding-in period, the
two-dimensional wear rate was lower in association with the radiostereometry
method (p < 0.05). There was, however, no difference between methods with
regard to the results of three-dimensional analysis (p = 0.10). The data
further validated the measurement accuracy of existing software.
Noble et al. analyzed 120 retrieved liners of eighteen different prosthetic
designs. The liners were made of conventional polyethylene. The mean duration
of in vivo use was eighty months. Multiple subsurface cracks measuring several
millimeters in length were found in 40% of the liners. Evidence of neck-liner
impingement was found in association with 32% of the liners. Crack initiation
from the region of impingement was observed in association with 70% of the
liners with cracks. Oxidative changes were present in 90% of the liners with
cracks. Impingement and oxidation were therefore the most important factors
leading to the formation of cracks within the polyethylene. Holley et al.
tested the effect of impingement against highly cross-linked polyethylene in
the laboratory. They tested liners that had been irradiated with three
different doses (2.8, 10, and 20 Mrad). The cups were mounted in the hip
simulator so that impingement resulted during every cycle. The liners were
tested for five million cycles. Wear damage was most severe in the liners that
had been irradiated at a dose of 20 Mrad, which showed pitting, delamination,
and cracking at the impingement sites after a half-million cycles. The damage
became more severe as the testing progressed. The authors concluded that
impingement may result in accelerated wear even of highly cross-linked
polyethylene. It is thus desirable to minimize impingement. This may be
accomplished with modifications of implant geometry, the use of
larger-diameter femoral heads, and the use of computer guidance systems for
more consistent component positioning.
Ceramic
D'Antonio et al. reported an update on ceramic-on-ceramic articulations.
The authors described two separate series with slightly different cup design.
The mean duration of follow-up was 5.2 years for the first 222 hips and 3.5
years for the second series of 209 hips. No ceramic fractures or bearing
failures occurred. The Harris hip scores were similar for both groups and were
comparable with those for a series of hips with identical implants with
metal-on-polyethylene bearings. Osteolysis was found in 1% of the hips in the
first series and in 0% of the hips in the second series. In contrast,
osteolysis was present in 18% of the hips with metal-on-polyethylene
implants.
Implant fracture is the most feared complication associated with ceramic
bearings. Garino et al. reported a 0.01% fracture rate between 2001 and 2003
in a report on more than one million femoral heads that had been inserted into
patients. The fracture rate associated with 32-mm heads was lower than that
associated with 28-mm heads. Eighty percent of the fractures occurred in the
first thirty-six months after surgery. The fracture rate varied from 0% to
0.04% among implants from different manufacturers. Bal et al. reported metal
staining in a study of thirteen alumina ceramic femoral heads that had been
retrieved after recurrent dislocation or inadvertent impingement against the
shell during surgery. The coupling was ceramic-on-ceramic in these implants.
The metallic staining was determined to have a chemical composition similar to
that of titanium alloy. Evidence of surface anomalies such as uneven wear,
cracks, embedded particles, pitting, and deep grooves was present in every
head that had been retrieved after recurrent dislocation. The clinical
relevance of these findings is unclear. The authors recommended that revision
should be a consideration when recurrent dislocation occurs in patients with
ceramic-on-ceramic couplings.
Metal-on-Metal
The current generation of metal-on-metal couplings was introduced into
clinical application in 1988. Numerous reports and abstracts on clinical
outcome, wear measurement, and metal ion analysis have been published over the
past fifteen
years10. This
bearing coupling has been used more frequently with the increase in surface
arthroplasty and the desire to use larger-diameter femoral heads to reduce
dislocation.
Clinical Series
Long, Dorr, and
Gendelman11
reported on the clinical performance of 161 hips that had been treated with
the Metasul articulation (Zimmer) performed by a single surgeon. The mean
duration of follow-up was 6.5 years (range, two to nine years). This series
represents the largest and longest clinical experience in the United States.
All cups were modular, with cementless fixation. The mean age of the patients
was 55.5 years. With regard to outcome, 98.6% of the patients rated the
clinical result as excellent or good with use of a self-assessment
questionnaire and 96.5% of the patients were able to walk without limitation.
Revision surgery was necessary in six hips (3.7%). One stem was revised
because of loosening. Five cups were revised because of liner dissociation due
to impingement at three years (one), unexplained pain with the suspicion of
possible metal hypersensitivity (two), recurrent dislocation (one), and
infection (one). There were no instances of pelvic osteolysis, although
radiolucent lines were observed behind 21% of the cups. There was no evidence
of femoral osteolysis in the surviving hips. Radiolucent lines were observed
around 9.9% of the stems, and calcar resorption was evident around 5.8%.
Migaud et al.12
followed thirty-nine hips with a metal-on-metal coupling for 6.6 years. The
patients in that study were part of a prospective trial in which
metal-on-metal bearings were compared with ceramic-on-polyethylene bearings.
The mean age of the patients was forty years. No implant loosening occurred.
The prevalence of osteolysis was significantly lower in the metal-on-metal
group (0% compared with 23%, p < 0.004). Kim et
al.13 reported the
results of sixty-eight cementless metal-on-metal total hip arthroplasties that
had been performed in patients younger than fifty years old. The mean duration
of follow-up was seven years. The result for 96% of the hips was rated as
excellent or good. No stem was loose, whereas two cups were radiographically
loose. Femoral osteolysis was present in two hips, and pelvic osteolysis was
present in one. The linear wear rate was measured to be 3.4 µm/yr in the
retrieved implants.
Proponents of metal-on-metal bearings have cited the advantage of using
large-diameter femoral heads, which offer the prospect of reducing
dislocation. Cuckler et
al.14 reported the
results associated with two series of hip arthroplasties that had been
performed with use of two implant designs that were identical except for the
articulation; specifically, a 28-mm metal-on-metal coupling was used in
seventy-eight hips, and a 38-mm metal-on-metal coupling was used in 616 hips.
The binomial distribution was used to assess the probability that the
dislocation rate was significantly different between the two groups on the
basis of an assumed risk of early dislocation of 2%. There were no
dislocations in the 38-mm group. Binomial analysis revealed that the rate of
dislocation was significantly lower for the larger diameter group (p <
0.001). The potential risks of metal-ion release and hypersensitivity must be
balanced against the lower risk of dislocation.
Wear
One of the major proposed advantages of metal-on-metal couplings is reduced
wear, resulting in a lower rate of osteolysis. The wear characteristics of
metal-on-metal couplings are influenced by several factors: carbon content,
manufacturing process, and diametral clearance. Rieker, Schon, and
Kottig15 described
what is perhaps the largest collection of retrieved metal-on-metal couplings,
including 608 individual components from 337 revisions. One hundred and
seventy-two pairs of these components were available for an analysis of
clearance (that is, the surface geometry match between the head and the
liner). The in vivo interval varied between one month and twelve years. The
authors reported several important findings related to in vivo wear behavior:
(1) the mean wear rate in the first year was high (27.8 µm/yr), (2) the
mean wear rate following the second year was low (6.2 µm/yr), and (3)
regression analysis showed clearance to be the most important variable
correlated with the linear wear rate (p = 0.0005). Current laboratory and
clinical retrieval data on metal-on-metal couplings support the idea that
superior wear characteristics are associated with specific features: (1) high
carbon content, (2) wrought manufacturing, (3) large diameter, and (4) low
clearance.
Metal Ion Release
Heisel et al.16
evaluated the relationship between activity and serum ion concentrations in a
study of seven healthy patients with well-functioning metal-on-metal hip
replacements. Activity was monitored with use of a two-dimensional
accelerometer for two weeks, with a treadmill test being performed after the
first week. The patients were instructed to reduce activities during the first
week while increasing activities during the second week. There was no
significant change (p > 0.05) in the serum levels of cobalt and chromium
for a given patient, regardless of activity. There also was no change in the
urine chromium level. The authors concluded that it was unnecessary to adjust
for patient activities when performing measurements of serum ion levels to
monitor patients with metal-on-metal couplings.
Immune Response
Several papers focused on the histological evaluation of periprosthetic
tissue retrieved from patients with failed and well-functioning total hip
replacements with metal-on-metal
couplings17.
Moreover, several reports presented data on the immune response to
metal18, the
induction of cellular
necrosis19, and
chromosomal
aberrations20.
Surgeons and research scientists agree on the concerns regarding the potential
biological effects of metal debris and metal ions. At the present time, there
is no conclusive evidence regarding any adverse clinical impact from metal
debris and ion release in patients with metal-on-metal articulations.
The histological appearance of periprosthetic tissue obtained from hips
with early-generation metal-on-metal couplings was generally characterized by
a mild foreign-body reaction. In 2000, German researchers first reported an
unusual perivascular lymphocytic infiltrate with histological features
resembling those associated with a type-IV hypersensitivity reaction. Willert
et al.17 evaluated
hip tissue from nineteen consecutive patients who underwent aseptic revision
of a metal-on-metal total hip replacement. Routine histological and
immunochemical staining methods were used. The principal reason for revision
was persistent pain with or without implant loosening. The mean time to
revision was thirty-three months. Loosening was found in association with
seven cups and seven stems. Histological findings included metal debris and
lymphocytic infiltrate in every specimen. Eosinophilic granulocytes were found
in 40% of the specimens. Fibrin exudates and necrosis were both consistently
present. Immunohistochemical analysis confirmed the presence of macrophages
and of both T and B lymphocytes. The authors were unable to establish a
connection between the immunological response and the quantity of metal
debris. It is of special interest to note that no improvement occurred in five
patients in whom revision involved an exchange to another metal-on-metal
articulation. Clinical improvement was realized in all other patients, who
received a different bearing surface coupling. Davies et
al.21 analyzed hip
tissue obtained at the time of revision of twenty-five cobalt
chromium-on-cobalt chromium, nine cobalt chromium-on-polyethylene, and ten
titanium-on-polyethylene total hip arthroplasties. Control tissues were
obtained from nine osteoarthritic hips at the time of primary total hip
arthroplasty. Perivascular lymphocyte infiltrate was seen in seventeen (68%)
of the twenty-five specimens from the metal-on-metal group. Plasma-cell
infiltrate was present in ten (40%) of the twenty-five specimens. The authors
did not observe any lymphocytic infiltration in the specimens from hips with
metal-on-polyethylene articulations. Kim et
al.13 reported on
the histological analysis of tissues retrieved from an area of pelvic
osteolysis behind a cementless acetabular shell with the metal-on-metal
articulation seven years after surgery. These authors also found abundant
lymphocytic infiltration, particularly concentrated around the perivascular
regions. They did not observe any metal or polyethylene particulate debris on
light microscopy.
Hallab et al.18
analyzed cell-mediated hypersensitivity in a study of thirty-four patients.
Nine patients had a metal-on-metal coupling, whereas seven had a
metal-on-polyethylene coupling. The other patients were either healthy
controls or patients who had osteoarthritis and were awaiting surgery. The
highest prevalence of reactivity to any metal challenge was in the
metal-on-metal group (60%). The lymphocyte proliferation response to a metal
challenge was significantly greater in the metal-on-metal group than in the
other groups (cobalt, p < 0.004; nickel, p < 0.01). Most importantly,
lymphocyte reactivity was positively correlated with serum metal levels in the
metal-on-metal group. While the clinical importance of these data is unclear,
the possibility of metal hypersensitivity as a cause of failure cannot be
excluded. Chromosomal aberrations, including aneuploidy and translocations,
have been documented in patients with failed metal-on-polyethylene couplings.
Ladon et al.20
conducted a prospective study of ninety-five patients who underwent total hip
arthroplasty with use of metal-on-metal couplings. Blood samples were obtained
before surgery and at six months, one year, and two years after surgery. The
serum levels of cobalt and chromium were significantly higher after surgery as
long as two years postoperatively (p < 0.001). Cytogenic data reflected
significantly greater aneuploidy (p < 0.001) and translocation (p <
0.01) at all time-periods in peripheral blood lymphocytes. While the
postoperative-to-preoperative ratios continued to increase with longer
follow-up intervals, there was no correlation between serum metal
concentration and cytogenetic aberrations. These studies and others have
clearly established that there is a biological response to the metal ions from
current metal-on-metal bearings. Careful longitudinal monitoring of patients
with such bearing couplings must be continued to conclusively determine the
clinical relevance of these changes.
 |
Minimal Incision Surgery
|
|---|
Few high-quality peer-reviewed studies on the efficacy and safety of
minimal incision techniques have been published. Klein et al. conducted a
survey of the members of the Hip Society who were in active clinical practice.
Only 18% (eighteen) of 102 respondents made reference to minimal incision
techniques on their web sites. Data on the clinical outcome of minimal
incision surgery were referenced on only one site. Accelerated rehabilitation
was referenced on 7% of the sites. Despite the limited application in most
senior surgeons' clinical practices, minimal incision hip arthroplasty has
continued to receive intense attention both in the orthopaedic community and
in the lay press. Ogonda et
al.22 reported the
results of the first large, prospective, randomized, blinded trial of a
minimal incision technique. Two hundred and nineteen patients underwent
unilateral hybrid total hip arthroplasty through a posterior approach over a
six-month period. They were randomized to either a 16-cm (traditional) or
10-cm (minimal incision) technique. The patients were blinded to the surgical
techniques. All procedures were performed by a single surgeon who routinely
performed >400 total hip arthroplasties each year. Moreover, the surgeon
had already performed >300 minimal incision hip arthroplasties with use of
the particular surgical technique prior to the beginning of the study. All
patients received the same protocol for anesthesia, pain management, and
perioperative rehabilitation. There was no difference between the two groups
with regard to patient age, body mass index, anesthesia risk (ASA class),
preoperative functional status (according to the Harris and Oxford hip
scores), or general health status (according to the WOMAC and SF-12
instruments) (p > 0.02 for all categories). Outcome measures included pain
assessment with use of a visual analog scale and the recording of analgesic
use. Moreover, physical function was quantified with gait analysis. The
estimated blood loss during surgery was significantly lower in the minimal
incision group (p = 0.03); this was the only significant difference between
the groups. Analysis of a subgroup of patients who had a body mass index of
>35 demonstrated increased operative time regardless of the surgical
approach used. There was no difference between the groups with regard to pain
scores or the use of analgesics in the first thirty-six hours after surgery (p
> 0.22). At six weeks after surgery, there was no difference between the
groups with regard to any of the functional or general-health outcome measures
(p > 0.33). There also was no difference between the groups with regard to
gait or stair-climbing ability (p > 0.22). Radiographic evaluation
demonstrated no difference in cup or stem position or in cementing grade.
There was no difference with regard to complications. Finally, there was no
difference with regard to the length of hospital stay (p = 0.94).
Other surgeons have reported significantly shorter hospital stays (less
than twenty-four hours), accelerated improvement of function, and reduced pain
in association with minimal-incision total hip
arthroplasty23.
Multiple factors other than the surgical approach (i.e., anesthesia, pain
management, physical therapy protocol, and patient selection) could account
for the different data. Swanson reported on his experience with the use of a
posterior minimal incision approach for the management of 1000 patients over a
five-year period. The mean operative time was fifty-three minutes, and the
mean blood loss was 307 mL. Despite this relatively low blood loss, 40% of the
patients required at least one unit of blood transfusion. The mean length of
the incision was 9.6 cm (range, 7.0 to 15.0 cm). The mean length of stay in
the hospital was 3.8 days. Complications included infection (prevalence, 1%),
skin necrosis (prevalence, 1%), and nerve palsy (prevalence, 0.8%). The most
common complication was dislocation (prevalence, 3.1%). There were no data on
femoral fractures. After a mean duration of follow-up of thirty-seven months,
all stems were stable and six cups were loose. Matta reported on his
experience with the performance of 386 consecutive primary total hip
arthroplasties with use of an anterior minimal incision technique. This
technique requires traction with use of a specialized table. The mean
operative time was 1.5 hours. The mean length of stay in the hospital was four
days. There were three fractures of the trochanter, two ankle fractures from
traction, one fracture of the calcar, and one fracture of the acetabulum. The
author provided no functional outcome data and no long-term clinical or
radiographic follow-up data.
Computer-assisted-surgery techniques have received increasing attention,
particularly when used in conjunction with minimal-incision surgery. Wixson
and McDonald used a computer guidance system in conjunction with a posterior
minimal incision technique in eighty-two hips. The authors compared the cup
position measurements for this group with those for a group of control
patients in whom the procedures were performed with use of a conventional
posterior approach. There was no difference between the groups with regard to
cup abduction and anteversion angles. However, the variability from patient to
patient was significantly less in the computer guidance group (p = 0.01).
These and other previously presented data support the ability to decrease the
variability of cup position when a computer guidance system is used. There
were no dislocations in either group.
The enthusiasm for minimal-incision hip arthroplasty was initiated by the
surgeons who introduced the two-incision surgical approach. There has been
controversy with regard to the proposed clinical efficacy, safety, and
marketing of this technique. Bal et al. reported short-term (six-month)
results of eighty-nine consecutive hip arthroplasties that had been performed
with use of the two-incision technique as proposed by Mears and Berger.
Reoperation was necessary for nine patients (10%). Complications included two
femoral fractures, one dislocation, two wound infections, and four episodes of
implant loosening. Injury to the lateral femoral cutaneous nerve occurred in
25% of the patients; all of these injuries resolved. There were no reported
cases of sciatic nerve palsy, but there was one case of femoral nerve palsy.
Pagnano et al. compared the results of eighty consecutive hip replacements
that had been performed with use of the two-incision technique with those of
160 consecutive hip replacements that had been performed with use of a
conventional incision technique. The rate of early complications was 14%
(eleven of eighty) in the minimal incision group, compared with 3.8% in the
conventional incision group. In the minimal incision group, there were four
intraoperative and three postoperative femoral fractures and there was one
episode each of dislocation, stem subsidence, and deep infection. One of the
most important findings was that femoral fractures continued to occur even
after the surgeon had performed more than sixty procedures.
Surgeons and engineers have continued to develop new surgical approaches,
retractors, instrumentation, computer guidance systems, multimodal
pain-management protocols, and accelerated rehabilitation programs in the hope
of improving the clinical outcome following total hip arthroplasty, regardless
of the size of the skin incision. It is hoped that further refinement of the
techniques and instrumentation will enable surgeons to perform
minimal-incision total hip arthroplasty with reproducible efficacy and minimal
complications.
 |
Complications
|
|---|
Surgeon Volume
Surgeon volume has been cited as a factor affecting the variations in
complications23.
Sharkey et al.24
reviewed the outcome of 1000 hip arthroplasties (including 786 primary
procedures and 214 revisions) that had been performed over a one-year period
at a high-volume tertiary joint arthroplasty center. The combined rate of
orthopaedic and medical complications in the first six months was 7.9% for
primary procedures and 16.5% for revision procedures. The greatest differences
between the primary and revision procedures were the rates of infection and
cardiac problems. The authors concluded that there is a baseline complication
rate for total hip arthroplasty, regardless of volume.
Thromboembolic Disease
It is agreed that prophylaxis against venous thromboembolism is required
following total hip arthroplasty. Substantial controversies remain with regard
to which method is the safest and most effective. The newest form of
prophylaxis is the use of an oral direct thrombin inhibitor. Extensive phase-3
clinical trials of one such direct thrombin inhibitor (ximelagatran) have been
performed in patients managed with hip or knee arthroplasty. Ximelagatran was
more efficacious than warfarin in patients managed with knee arthroplasty (p =
0.003)25, but it
was not superior to low-molecular-weight-heparin in patients managed with hip
arthroplasty. There was no difference between warfarin and
low-molecular-weight heparin with regard to bleeding complications. A
registration request for this agent was rejected by the Food and Drug
Administration in 2004, principally on the basis of concerns related to
associated abnormalities seen in liver-function studies in treated
patients.
Eriksson et
al.26 reported the
phase-2 clinical trial data on another new oral direct thrombin inhibitor
(dabigatran). The study included nearly 2000 patients managed with hip or knee
arthroplasty. The administration of dabigatran was started within one to four
hours after surgery. The comparator was low-molecular-weight-heparin
(enoxaparin), which was started before surgery and was continued at a dose of
40 mg/day after surgery. The overall rate of thrombosis was significantly
lower in patients receiving dabigatran (range, 13.1% to 16.6%) than in those
receiving enoxaparin (24%) (p = 0.04). There was, however, a higher rate of
bleeding complications, particularly with higher doses, among patients
receiving dabigatran (p = 0.05). The efficacy and safety of this agent are
currently being tested in phase-3 clinical trials.
Controversies exist with regard to the necessity of extended prophylaxis.
Pellegrini et al. reported data for >1800 patients. The protocol involved
the administration of adjusted-dose warfarin (with a target international
normalized ratio of 1.5 to 2.0) after surgery and a screening venogram at the
time of discharge. No further prophylaxis was continued if the venogram was
negative. Adjusted-dose warfarin was continued for three months if the
venogram was positive for calf thrombosis and for six months if it was
positive for proximal thigh thrombosis. The thrombosis rate was 14.7% for
patients managed with hip replacement and 41.3% for patients managed with knee
replacement. The rate of readmission to the hospital because of symptomatic
thromboembolism was 0.82% for patients with a positive venogram (who had been
managed with continued administration of adjusted-dose warfarin), compared
with 1.9% for those with a negative venogram (who had been managed with
discontinuation of warfarin). In the hip replacement group, a higher rate of
thromboembolism was noted after warfarin was discontinued (0.7% vs. 1.8%, p
< 0.01). No such difference was noted in the knee replacement group. While
adjusted-dose warfarin was less effective than some of the newer
anticoagulants, extended prophylaxis with use of this agent did reduce
symptomatic thromboembolism following total hip arthroplasty.
Salvati et al. reported a significantly higher prevalence of heritable and
developmental thrombophilic abnormalities in patients with documented venous
thromboembolic disease following total hip arthroplasty. The investigators
quantified numerous genetic mutations and serological markers known to be
associated with thrombophilia in forty-three patients (twenty with proximal
deep-vein thrombosis as documented with magnetic resonance venography and
twenty-three with symptomatic pulmonary embolism as documented with a
ventilation-perfusion lung scan). These patients were matched to a group of
control patients who underwent total hip arthroplasty but did not have a known
venous thromboembolic event. Significant differences between the two groups
were found with regard to antithrombin deficiency (p = 0.02), protein-C
deficiency (p = 0.02), and prothrombin gene mutation (p = 0.0037). The
likelihood of having at least one of these three findings was significantly
more common in patients who had a thromboembolic event (p < 0.0001). A
model constructed with use of these parameters for the prediction of
thromboembolism demonstrated a sensitivity of 50% but a specificity of 93%. It
is hoped that analysis for thrombophilia can assist in the stratification of
risk to modify prophylaxis following hip arthroplasty in the future.
Dislocation
Recurrent dislocation has now become the third most frequent cause of
revision surgery, resulting in an intense focus on surgical technique,
large-diameter articulations, increased femoral stem offset, and
rehabilitation protocols. One of the most common methods with which to address
dislocation is the use of a constrained acetabular liner. Callaghan et
al.27, in a study
of thirty-one hips, reported the results of cementing a constrained liner into
a well-fixed acetabular shell. The mean duration of follow-up was 3.9 years.
Two liners failed: one because of debonding between the liner and the cement,
and the other because of failure of the capturing mechanism. No shell was
loose. This particular liner design and surgical technique can be a successful
option in certain difficult cases. Berend et al. reported on a very large
series of hips that had been treated with constrained liners. The surgeons
inserted 720 constrained liners over a seven-year period, with 91.4% of the
liners being inserted at the time of revision or conversion surgery. The rate
of survival of the liner was only 57.9%. Despite the constraint, the rate of
dislocation was 17.5% overall and 28.5% in the subgroup of patients who had
had a previous dislocation. Aseptic revision for loosening was necessary in
15% of the hips. Other major complications included infection (prevalence,
6.2%) and periprosthetic fractures (prevalence, 3%). These data reflect the
need for further improvements in implant design and surgical technique in
order to address this common clinical problem.
Infection
Di Cesare et al. evaluated the efficacy of using serum interleukin-6 levels
as a marker for infection in a study of fifty-eight patients (seventeen of
whom had an infection and forty-one of whom did not). Significantly elevated
levels were found in the patients with infection (p < 0.01). Elevated
levels were found to have a sensitivity of 100%, a specificity of 95%, a
positive predictive value of 89%, a negative predictive value of 100%, and an
accuracy of 97%. This test may be of value in some cases, particularly for
excluding infection as a cause of a suboptimal clinical result. Selgrath et
al. performed polymerase chain reaction analysis on the synovial fluid from
157 joints in patients who were scheduled to undergo revision hip or knee
arthroplasty. A discordant result between the results of routine bacterial
culture and polymerase chain reaction was found in twenty-four samples;
specifically, ten samples demonstrated a positive result on culture and a
negative result on polymerase chain reaction whereas fourteen samples
demonstrated a negative result on culture and a positive result on polymerase
chain reaction. No clinical outcome data were provided for these patients. The
authors recommended changes in the protocol to improve the sensitivity and
specificity of this test in the diagnosis of arthroplasty infections.
A two-stage reimplantation protocol has been used for the treatment of deep
infection around joint replacements for more than two decades. Goldberg et al.
reported on thirty-one consecutive patients who had been managed with a
two-stage protocol that included removal of the implants, administration of
antibiotics for six weeks, and reimplantation with use of cementless fixation.
There were no infections following reimplantation. One patient had a late
infection with a different organism sixty-six months after reimplantation. Two
cups and one stem were revised because of aseptic loosening. Marculesca et al.
reviewed the results of a two-stage protocol in a study of forty-three
patients who had infections with methicillin-resistant organisms. The mean
duration of follow-up was thirty-three months. Infection recurred in 16% of
the patients, with six of the seven reinfections being caused by the same
organism. Moreover, 7% of the patients had positive histopathological studies
at the time of reimplantation. These patients were managed with chronic
suppressive therapy, and none of them had development of a clinically apparent
infection.
 |
Practice Management
|
|---|
Wound Drain
The use of wound-suction drains following total hip arthroplasty is
controversial. Parker et
al.28 conducted a
meta-analysis evaluating the efficacy of using and not using wound drains
following total hip and total knee arthroplasty. The investigators selected
eighteen prospective, randomized studies involving 3495 patients with 3689
wounds. There was no difference between patients who had been managed with a
drain and those who had not with respect to the occurrence of wound infection,
hematoma, or reoperation for wound complications. There was also no difference
with respect to pain, thromboembolism, or range of motion. The only
significant difference was a greater rate of transfusion among patients who
had been managed with a drain (p < 0.02).
Blood Transfusion
Limiting allogeneic blood transfusion is desirable because it would reduce
the potential for viral disease transmission as well as cost. Pierson et
al.29, in a study
of patients undergoing total hip and total knee arthroplasty, presented a
blood-conservation algorithm, based on a mathematical formula, that was used
to calculate the projected lowest hemoglobin level after surgery. If this
level was <7.0 g/dL, the patient was offered preoperative erythropoietin
treatment. No intraoperative or postoperative blood salvage was done. Two
groups were retrospectively identified: the first group comprised 433 patients
for whom the algorithm was implemented, and the second group comprised
sixty-seven patients for whom the algorithm was not implemented for a variety
of reasons (primarily the patient's insistence on preoperative autologous or
donor-directed blood donation). The overall transfusion rate was 2.1% among
the patients for whom the algorithm was implemented (2.8% among those managed
with hip replacement and 1.4% among those managed with knee replacement),
compared with 16.4% among those for whom it was not implemented (p <
0.0001). The rate of major complications in the first ninety days was 1.4%;
the complications included three deaths (two of which were due to a myocardial
infarction and one of which was due to a cerebral infarct), three nonfatal
myocardial infarctions, and one pulmonary embolism. There was no association
between these complications and anemia.
Pharmacological Agents and Bone-Remodeling
The adverse effects of nonsteroidal anti-inflammatory drugs on fracture
repair and bone-remodeling have been extensively studied. Andersen et al.
analyzed the revision rate in patients in the Danish Hip Arthroplasty Registry
who had received nonsteroidal anti-inflammatory agents after total hip
arthroplasty. More than 43,000 hips were entered into the Registry between
1995 and 2003. In 7185 of these cases, the patient received nonsteroidal
anti-inflammatory drugs during the perioperative period. The revision rate
among patients who had been managed with a cementless replacement and
nonsteroidal anti-inflammatory drugs was higher than that among patients who
had not received nonsteroidal anti-inflammatory drugs (relative risk, 3.09).
In contrast, the revision rate among patients who had been managed with a
cemented hip replacement and nonsteroidal anti-inflammatory drugs was lower
than that among patients who had not received nonsteroidal anti-inflammatory
drugs, (possibly because of a protective effect). The investigators
recommended avoiding the use of nonsteroidal antiinflammatory medications
after surgery if cementless fixation was used. Lionberger and Noble conducted
a prospective, placebo-controlled, double-blind study investigating the effect
of a cyclooxygenase-2 inhibitor on bone-remodeling following cementless total
hip arthroplasty. Forty-nine patients were randomized to receive either
placebo or celecoxib (200 mg/day). Treatment was continued for six weeks.
There was no difference between the groups with regard to the bone mineral
density around the implants at three or six months after surgery (p = 0.56).
There also was no difference with regard to bone density in the femoral Gruen
zones. The concentration of N-telopeptide (a marker of bone turnover) was
significantly higher in the celecoxib group at six weeks (p = 0.004) but not
at twelve weeks (p = 0.23). No adverse changes were observed on regular hip
radiographs with regard to signs of osseointegration. The authors concluded
that there were no adverse effects in association with the administration of
low-dose celecoxib for six weeks following cementless total hip
arthroplasty.
Periprosthetic femoral bone loss due to stress transfer is generally
greater in association with cementless implants and in Gruen zone 7 (the
calcar region). Decreasing periprosthetic bone loss is important because more
patients are receiving cementless total hip replacements and because the
implants remain in place for longer durations. Arabmotlagh et al. conducted a
prospective, randomized, placebo-controlled study of fifty-one patients
undergoing cementless hip arthroplasty. One group received a placebo for two
months, whereas the other group received a bisphosphonate (alendronate). The
bisphosphonate group was then further studied by randomization of the patients
to continued treatment with the bisphosphonate at a lower dose for either two
or four additional months. Patients who were managed with the bisphosphonate
for six months still had bone loss in zone 7 (p = 0.05) but had increased bone
mineral density in zones 4 and 5 (p = 0.01). The marker of bone resorption
(C-terminal telopeptide of type-1 collagen) decreased for as long as six
months in association with bisphosphonate treatment. One marker of bone
formation (bone-specific alkaline phosphatase) increased, whereas another
(osteocalcin) remained unchanged in association with bisphosphonate treatment.
Bhandari et al.30
conducted a meta-analysis of the publications from 1989 to 2003 to evaluate
the effect of bisphosphonates on periprosthetic bone mineral density following
total hip arthroplasty. Six studies, with a total of 290 patients, met the
inclusion criteria. Bisphosphonate treatment was associated with significantly
less bone loss at three months (p < 0.01), six months (p < 0.001), and
twelve months (p = 0.03). The effect was more pronounced in hips with cement
fixation compared with those with cementless fixation. The major limitations
of these studies were that they only evaluated short-term effect and that
there was no correlation with functional outcome or revision rate. The current
evidence regarding the beneficial effects of bisphosphonates on periprosthetic
bone loss should be interpreted with caution until more data are generated in
larger populations of patients and there is longer follow-up involving
correlation with clinical and radiographic parameters.
Joint Registry
The North American Outcomes Registry for Total Hip and Knee Replacement was
initiated in 1995. Experience with this registry can be invaluable to surgeons
and researchers who are working on the American Joint Replacement Registry
pilot program sponsored by the American Academy of Orthopaedic Surgeons.
Callaghan et al. reported on patient enrollment, follow-up data, and costs.
One thousand two hundred and nineteen surgeons registered between 1995 and
2001; however, only 489 (40%) actually entered patient data. Surgeon
enrollment decreased from 489 in 1995 to 133 in 2001. Nearly 39,000 patients
were entered into the Registry during this seven-year period. There was a
decrease in patient volume from 1997 to 2001 for both total hip arthroplasty
(from 1500 to 1200) and total knee arthroplasty (from 3000 to 1600). The rate
of completion of the one-year follow-up data form was 24% in 1998 and 30% in
2001. However, the rate of completion of the two-year follow-up form was 6% in
1998 and 11% in 2001. The cost for maintaining this registry was approximately
$750,000 annually. There is a need to refine the reporting methodology in
order to achieve higher compliance rates for future registry initiatives.
Moreover, the goals of a registry must be clearly defined in order to achieve
meaningful data collection.
 |
Cost Analysis
|
|---|
Rising health-care costs and diminishing health-care resources have forced
orthopaedic surgeons and other health-care professionals to develop innovative
methods to continue to provide cost-efficient and high-quality care to our
patients. The financial burden will continue to escalate with the projected
increase in the volume of surgery. One of the most challenging areas of focus
is in revision total hip arthroplasty.
Antoniou et
al.31 conducted a
relatively simple analysis to compare the in-hospital cost of primary total
hip arthroplasty in three tertiary teaching hospitals each in Canada (940
patients) and in the United States (739 patients). These were relatively large
hospitals with bed capacities ranging from 500 to 850. All procedures were
done between 1999 and 2001. The cost figures were not adjusted for inflation.
Data were extracted from the Transition cost-accounting system. The total cost
for a given patient involved direct cost (personnel and supplies) and overhead
cost (administration and housekeeping). Direct cost represented 68.9% of the
total cost in Canada and 62.9% of the total cost in the United States. The
mean total cost was dramatically different between the two countries: $6766 in
Canada and $13,339 in the United States (p < 0.0001). The mean length of
stay was significantly (p < 0.0001) longer in Canada (7.2 days) than in the
United States (4.2 days). There was no difference in terms of complication
rates. Data on implant cost were available only from one hospital each in
Canada ($1695) and in the United States ($8017). The authors concluded that
cost-containment efforts in the United States should be focused on reducing
implant cost.
Crowe, Sculco, and Kahn presented a hospital cost and reimbursement
analysis of revision hip
arthroplasty32. The
investigators randomly selected fifty-one revisions that had been done between
1995 and 1999 at a tertiary joint arthroplasty hospital. The mean length of
stay in the hospital was 7.4 days. The mean operative time was three hours and
forty minutes, and the mean length of stay in the recovery room/intensive care
unit was fourteen hours and twenty minutes. Approximately equal numbers of
patients received cemented and cementless stems. A majority of the cup
revisions were done with use of cementless fixation. Bone-grafting was
necessary for 59% of the acetabulae and 31% of the femora. Major medical
complications occurred in 18% of the patients. Patients younger than
sixty-five years of age had fewer complications than older patients did
(prevalence, 10% compared with 23%). The mean cost per case was $21,224
(range, $10,165 to $44,602). There was a significant difference in cost
between procedures that involved bone-grafting ($28,097) and those that did
not ($17,245) (p = 0.004). There was also a significant difference between
older patients (that is, patients who were more than sixty-five years old) and
younger patients ($23,417 compared with $18,309; p = 0.016). The mean
reimbursement to the hospital was $15,822, reflecting a loss of $5402 per
case. The mean reimbursement for Medicare patients was less than that for
non-Medicare patients ($14,800 compared with $17,176). Every Medicare patient
incurred a loss, and the mean loss was $8617 per case. Bozic et
al.5 evaluated the
clinical, demographic, and economic data associated with 491 consecutive
unilateral primary and revision total hip arthroplasties performed at a single
institution in a three-year period (January 2000 to December 2003). There was
a significant (p < 0.0001) difference in the severity-of-illness score
between patients managed with primary and revision procedures. The
intraoperative blood loss (p < 0.0001), operative time (p < 0.0001), and
length of hospital stay (p < 0.0005) were also significantly greater in the
revision group. There was no difference between groups with regard to the
overall complication rate (p = 0.072). However, there was a higher rate of
readmission within ninety days in the revision group (p = 0.05). The mean cost
of revision arthroplasty (in 2003 dollars) was significantly greater than that
of primary arthroplasty ($31,341 ± $11,989 compared with $24,170
± $6,700; p < 0.0001). Moreover, there was a significant difference
in every cost category (implant, operating room, post-anesthesia care unit,
nursing, radiology, laboratory, and pharmacy). Multivariate regression
analysis demonstrated that higher cost was related to greater severity of
illness and to the presence of bone deficiencies in the acetabulum and
femur.
Bozic et al., at the 2004 meeting of the American Association of Hip and
Knee Surgeons, presented additional economic data from a study of 4533 total
hip arthroplasties that had been performed at three centers over the same
three-year period (from 2000 to 2003). The study included 3048 primary and
1485 revision procedures. The operative time (p < 0.001), utilization of
bone graft (p < 0.0001), length of hospital stay (p < 0.0001), and
utilization of extended-care facilities after discharge (p < 0.0001) were
all significantly greater in the revision group. Hospital costs relative to
primary hip arthroplasty (100%) were higher for procedures involving revision
of both components (138%), isolated revision of the stem (129%), and isolated
revision of the cup (101%) (p < 0.0001). This disparity and the expected
dramatic increase (>12% to 15% annually) in revision procedures will
undoubtedly put an enormous burden on the health-care delivery system in the
United States in the years to come.
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Evidence-Based Orthopaedics
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The editorial staff of The Journal reviewed a large number of
recently published research studies related to the musculoskeletal system that
received a Level of Evidence grade of I. Over 100 medical journals were
reviewed to identify these articles, which all have high-quality study design.
In addition to articles published previously in this journal or cited already
in this update, six level-I articles were identified that are relevant to
total hip arthroplasty. A list of those titles is appended to this review
after the standard bibliography. We have provided a brief commentary about
each of the articles to help guide your further reading, in an evidence-based
fashion, in this subspecialty area.
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Future Meetings and Educational Courses
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The major conferences that focus on peer-reviewed scientific data
presentations are the annual meeting of the American Association of Hip and
Knee Surgeons (to be held in Dallas, Texas, on November 4, 5, and 6, 2005),
the annual meeting of The Hip Society (to be held on Specialty Day in New
Orleans, Louisiana, on March 11, 2006), the annual meeting of the American
Academy of Orthopaedic Surgeons (to be held in New Orleans, Louisiana, from
March 8 to 12, 2006), and the annual meeting of the Orthopaedic Research
Society (to be held in New Orleans, Louisiana, from March 5 to 8, 2006). The
American Academy of Orthopaedic Surgeons generally offers two or three
continuing medical education courses annually. Finally, peer-reviewed
scientific presentations also are given at the annual meetings of the regional
orthopaedic societies such as the Eastern, Mid-American, Southern, and Western
Orthopaedic Associations.
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Evidence-Based Articles Related to Total Hip Arthroplasty
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Sanders C, Donovan JL, Dieppe PA. Unmet need for joint replacement:
a qualitative investigation of barriers to treatment among individuals with
severe pain and disability of the hip and knee. Rheumatology
(Oxford). 2004;43:353-7.
Wide variations exist in terms of access to joint arthroplasty. This is
especially a problem in public health systems such as in the United Kingdom.
The authors identified twenty-seven patients who had high levels of hip and/or
knee pain and disability due to arthritis. These patients were interviewed
initially and again five years later. Identical measures of health status were
used during both time-periods. The mean age was seventy-six years. Only 50% of
the patients were referred to a specialist in orthopaedics or rheumatology.
Three types of barriers were identified: (1) the patient's own reluctance to
seek treatment from a specialist, (2) the primary-care physician's reluctance
to refer the patient, and (3) the perception of the ineffectiveness and risks
of joint arthroplasty. The authors concluded that there was a need to improve
the education of primary-care physicians and patients with regard to the
indications for, and the efficacy and risks of, joint arthroplasty. These
barriers may not be as pronounced in the United States.
Temmerman OP, Raijmakers PG, David EF, Pijpers R, Molenaar MA, Hoekstra
OS, Berkhof J, Manoliu RA, Teule GJ, Heyligers IC. A comparison of
radiographic and scintigraphic techniques to assess aseptic loosening of the
acetabular component in a total hip replacement. J Bone Joint Surg
Am. 2004;86;2456-63.
Cup fixation was evaluated in eighty-six consecutive hips with use of plain
radiographs, bone scintigraphy, subtraction arthrography, and nuclear
arthrography. Seventy percent of the cups were cemented, and 30% were
cementless. Plain radiography was the best single method, with a specificity
of 85% and a sensitivity of 85%. The interobserver correlation coefficient was
0.37. Multivariate analysis demonstrated the efficacy of multimodal
evaluation. Subtraction arthrography and bone scintigraphy both had a
significant predictive value for cup loosening when used in conjunction with
plain radiography (p < 0.05). These methods were especially valuable if the
studies were negative as 95% of the stable cups were in hips that had normal
radiographs and normal adjunct studies. A negative study (specificity) is more
valuable to the clinician in deciding whether surgery is indicated.
Karachalios T, Tsatsaronis C, Efraimis G, Papadelis P, Lyritis G,
Diakoumopoulos G. The long-term clinical relevance of calcar atrophy
caused by stress shielding in total hip arthroplasty: a 10-year, prospective,
randomized study. J Arthroplasty. 2004;19:469-75.
Eighty women with osteoarthritis of the hip were randomized into four
groups, each of which received a different stem design inserted without
cement. The mean age was seventy years. One type of stem was made of
cobalt-chromium alloy, and the other three types were made of titanium alloy.
The stems had four different surface textures: macrointerlock, hydroxyapatite
coating, proximal coating with beads, and matte surface. There were four
different cross-sectional geometries. In all patients, progressive bone loss
in the calcar region (Gruen zone 7) was evident as much as two years
postoperatively, with the reduction in bone density values ranging from 8% to
24%. The reduction from the baseline value was significant in association with
three of the four stem designs. A pattern of progressive recovery was observed
in all hips. The least change in bone mineral density was observed in hips
that had received a stem with a tapered geometry and a hydroxyapatite coating.
There was no difference among the groups with regard to the Harris hip score.
One of the limitations of the study was that the patients were relatively old.
The pattern of bone loss may be different in younger patients and after a
longer duration in situ. Differences in bone loss may be associated with
different stem designs, wear at the articulation, and other clinical
parameters.
Gonzalez Della Valle A, Slullitel G, Vestri R, Comba F, Buttaro M,
Piccaluga F. No need for routine closed suction drainage in elective
arthroplasty of the hip: a prospective randomized trial in 104 operations.
Acta Orthop Scand. 2004;75:30-3.
The authors randomized 104 patients undergoing unilateral total hip
arthroplasty to receive or not to receive a drain. Hybrid fixation was used in
40% of the procedures, and cementing of all components was performed in 60% of
the procedures. All procedures were done through a posterior approach with the
patient under hypotensive epidural anesthesia. Thromboembolic prophylaxis
involved intraoperative administration of heparin followed by administration
of aspirin for three weeks. The mean amount of drain collection was 290 mL.
There was no difference in blood transfusion rates.
There was, however, a significant reduction of hematocrit (p = 0.03) and a
longer length of stay (p = 0.01) in the group of patients who had received a
drain. There was no difference between the groups with regard to the
prevalence of draining wounds, hematoma, wound infection, or thromboembolism.
The clinical relevance of wound drains may be different in association with
hip arthroplasties performed through a different surgical approach, those
performed with the patient under normotensive general anesthesia, and those
performed with cementless fixation.
McGregor AH, Rylands H, Owen A, Dore CJ, Hughes SP. Does
preoperative hip rehabilitation advice improve recovery and patient
satisfaction? J Arthroplasty. 2004;19:464-8.
Thirty-five patients who were awaiting total hip arthroplasty were
recruited. The mean age was seventy-two years. The patients were randomized
into two groups: Group A received routine preoperative work-up and
preparation, and Group B received a preoperative hip-education booklet and
attended class for two to four weeks prior to surgery. Clinical assessment was
performed with use of the WOMAC, the Harris hip score, and a validated
disability scale for daily activities. Psychological assessment was performed
with use of several validated instruments. The patients in Group B reported
higher levels of satisfaction at the time of hospital discharge and at three
months after surgery (p < 0.01). Moreover, there was less discrepancy
between preoperative expectations and postoperative outcome in Group B (p <
0.05). There was no difference between the groups with regard to any of the
clinical outcome assessments. There was a 20% reduction in the mean length of
hospital stay in Group B, which contributed to a 20% reduction of overall cost
in that group. Preoperative education and physical conditioning programs
should increase the level of patient satisfaction after surgery. It is
unlikely that further reductions in the length of hospital stay and in cost
can be realized in the United States from these programs alone.
Pitto RP, Hamer H, Heiss-Dunlop W, Kuehle J. Mechanical prophylaxis
of deep-vein thrombosis after total hip replacement: a randomized clinical
trial. J Bone Joint Surg Br. 2004;86:639-42.
This study was designed to compare the effectiveness of
low-molecular-weight heparin with that of pneumatic compression foot pumps
when used for prophylaxis against deep-vein thrombosis. All surgical
procedures were performed with use of the direct lateral approach with the
patient under normotensive general anesthesia. An identical rehabilitation
protocol was used after surgery. Screening with use of duplex ultrasound scans
was performed before surgery and at three, ten, and forty-five days after
surgery. There were 100 patients in each group. No pulmonary emboli occurred
in either group. The total rate of deep-vein thrombosis was 3% for the
foot-pump group, compared with 6% for the low-molecular-weight-heparin group
(p < 0.05). The low-molecular-heparin group had greater wound drain output
(p < 0.05), more transfusions (p < 0.05), and more thigh swelling (p
< 0.05). The foot pump was used for an average of 19.4 hours per day
(range, fifteen to 21.5 hours per day). One of the major limitations of the
study was the fact that the mean length of hospital stay was twelve days. The
use of foot pumps as a stand-alone regimen may not be as effective if only
applied for three days, which is the typical mean length of hospital stay in
the United States.
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