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The Journal of Bone and Joint Surgery 81:1337-45 (1999)
© 1999 The Journal of Bone and Joint Surgery, Inc.

Current Status of Impaction Allografting for Revision of a Femoral Component*{dagger}{ddagger}

SETH S. LEOPOLD, MAJOR§, EL PASO, TEXAS and AARON G. ROSENBERG, M.D.#, CHICAGO, ILLINOIS

An Instructional Course Lecture, American Academy of Orthopaedic Surgeons


    Introduction
 Top
 Introduction
 Clinical Results of Impaction...
 Problems and Complications of...
 Algorithm for Femoral...
 References
 
There is a variety of reconstructive options for revision of a femoral component in the setting of loss of proximal bone stock. Techniques employing stems designed to be inserted with16,28,31,33 and without8,18,27 cement have demonstrated durable results on intermediate to long-term follow-up; the use of a bulk allograft1,4,34 and replacement of the proximal aspect of the femur have been advocated for patients who have a massive loss of bone stock24. This paper will focus on the clinical results of a newer technique in which allograft cancellous bone is impacted into the proximal aspect of the femoral canal to provide a so-called neo-endosteum for a component inserted with cement.

Impaction cancellous allografting for revision of a femoral component is a modification of a technique initially used for acetabular reconstruction in the setting of protrusio acetabuli32. To our knowledge, it was first used for femoral reconstruction without cement in 1985, in England21; two years later, the originators of the technique performed the procedure with cement11. Follow-up studies of patients who have had a procedure substantially similar to that described by Gie et al.11 have now been reported by a number of other groups6,7,25,26. The present review briefly describes the results of impaction allografting for revision of a femoral component reported to date, summarizes the known problems and complications with the technique, and presents an algorithm for revision hip arthroplasty in the setting of loss of femoral bone stock.


    Clinical Results of Impaction Allografting
 Top
 Introduction
 Clinical Results of Impaction...
 Problems and Complications of...
 Algorithm for Femoral...
 References
 
Several centers have reported the short-term follow-up results (at a minimum of six to twenty-four months) of the use of cancellous impaction grafting with cement for revision of a femoral component, typically with stems of a similar geometry (Table I)6,7,11,25,26. To our knowledge, femoral impaction allografting with cement was first described in the literature11 as being performed with use of the Exeter stem (Howmedica, Rutherford, New Jersey, and Howmedica International, Staines, Middlesex, England), which is a double-tapered, highly polished, noncollared device; another implant commonly used for the procedure6,7,26,29, the Collarless Polished Tapered (CPT) stem (Zimmer, Warsaw, Indiana), is similar in appearance. Advocates of the use of these devices with impaction grafting have stated that subsidence does not necessarily lead to clinical loosening because the stems have a so-called self-tightening geometry that allows restabilization within the cement mantle as subsidence occurs7,11. Cold flow of the cement mantle9 may help the stem to subside without becoming symptomatically loose. Subsidence of the wedge-shaped stem may also provide a beneficial compressive load to the bone graft20,29.


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TABLE I CLINICAL SERIES OF HIPS TREATED WITH IMPACTION ALLOGRAFTING

 
However, other authors have questioned the supposedly benign nature of stem subsidence6,25,26, and impaction allografting has been performed with the use of stems that resist subsidence. Implants that have a rough surface finish15 and a polymethylmethacrylate precoating19 have been used.

Two important problems limit comparison between clinical series described in published reports on impaction allografting. The most evident limitation is the inconsistent use of inclusion criteria. Whereas many investigators have attempted to limit inclusion to femora with more advanced stages of bone-stock loss19,25,26, others have specifically excluded some of those femora11 because one of the originators of the procedure expressed concerns about expanding the indications for impaction grafting to the most challenging femoral revisions21. Some series have consisted of a consecutive group of patients managed with a femoral revision21, whereas other reports have not defined any criteria for inclusion6.

Another important factor limiting comparison of clinical reports on femoral revision with impaction allografting is the large number of variables that may affect the outcome of the technique. Two series in which similar implants and similar inclusion criteria were used still may differ with respect to the cement (the technique, type, and viscosity), the allograft (the source, consistency, and pretreatment with irradiation or freeze-drying), the operative approach, and the postoperative care, to name only a few of the potentially important factors. The effects that most of these variables have on the results of this especially complex technique have yet to be described.

Polished, Tapered Stems
Femoral impaction allografting with cement has been performed with the Exeter stem in the United Kingdom11 and elsewhere25 as well as with the similar CPT stem.

In the first thorough report of the technique by Gie et al.11, fifty-eight hips were operated on by eleven different surgeons and were followed for a mean of thirty months. The average clinical scores for pain, function, and mobility improved, but the percentage of patients who received fair or poor clinical scores was not provided. Complications related to the prosthesis, including femoral fracture, perforation, and dislocation, were seen in seven (12 percent) of the fifty-eight hips. The investigators identified radiographic signs of incorporation of the cancellous graft or reconstitution of cortical bone stock in fifty (89 percent) of the fifty-six hips that were evaluated radiographically. The component subsided more than one millimeter in forty-four (79 percent) of the fifty-six hips. Especially troubling was the finding of subsidence at the interface between the graft-cement composite and host bone in 20 percent (eleven) of the fifty-six hips. Although subsidence continued for more than two years in 11 percent (six) of the fifty-six hips, there were no revisions for aseptic loosening. It is worth noting, however, that aseptic loosening is difficult to define for a stem implanted with this technique, as Gie et al. indicated that the device can subside at either the stem-cement interface or the graft-host bone interface and that radiolucent lines at those interfaces or at the graft-cement interface do not necessarily indicate loosening. Also worth noting is the reference that Gie et al. made to a patient excluded from analysis because the "femur showed endosteal bone lysis associated with a large cortical diaphyseal defect" at the time of revision; such a finding is now considered an important indication for impaction grafting. Differences in exclusion criteria may account for some of the differences between the results in this paper and those of studies in which the procedure was specifically reserved for use in femora with severe bone loss19,25,26.

Nevertheless, the initial optimistic report by Gie et al.11 provided impetus to other groups. Elting et al.7 reported on a consecutive series of sixty-seven femoral revisions performed with impaction grafting with use of the CPT stem. Clinical results were encouraging, although, as in the report by Gie et al., most of the femora had minimum bone loss (73 percent [forty-one] of the fifty-six hips available for follow-up at a minimum of twenty-four months). As in most series, most patients had pain relief; fifty (89 percent) of the fifty-six patients available for clinical follow-up reported mild or no pain, and only eight (14 percent) needed a walking aid full-time. However, Elting et al., like Gie et al., reported a high rate of subsidence of the component. About half (twenty-seven) of the femoral stems subsided at the prosthesis-cement interface, and nearly 20 percent (ten) demonstrated substantial subsidence (more than two millimeters); 7 percent (four) of the hips had subsidence of the graft-cement composite within the endosteum. The long-term importance of this finding is not known, and it is not obvious how the wedge-shaped stem might "self-tighten" if the entire mantle subsides. Despite these concerns, Elting et al. stated that they continue to use impaction grafting for all femoral revisions.

The contention that subsidence of polished, tapered stems in these patients is benign or beneficial7,11 has been questioned in three recent reports6,25,26. Eldridge et al.6, although they did not provide an exhaustive report of clinical outcomes, highlighted the potential adverse effects of subsidence. Those authors found substantial subsidence (more than five millimeters) in eighteen (23 percent) of seventy-nine patients who had had a revision with use of either the CPT or the Exeter stem; the rates of the complication were similar for the two stem designs. More worrisome, however, was a subset of nine (11 percent) of the seventy-nine patients who had more than ten millimeters of subsidence. Of these nine patients, all had pain in the thigh and all but one had had or were awaiting repeat revision.

Masterson et al.25 looked specifically at the quality of the cement mantle and its effects on subsidence. In their series, massive subsidence (more than ten millimeters) was seen in seven (20 percent) of thirty-five patients. Subsidence was associated with dislocation in two hips and revision in one, further refuting the premise that migration of the stem is clinically silent. Masterson et al. attributed subsidence to the difficulty in achieving a consistent cement mantle with this technique. Of 386 femoral zones of Gruen et al.12 that were analyzed radiographically in that series, 154 (40 percent) had no visible cement.

In an extremely thorough analysis of thirty-four patients followed for a minimum of twenty-four months, Meding et al.26 also questioned the importance of subsidence and gave specific attention to femoral fracture, the other common complication of the procedure. Two patients in that study had early failure that necessitated revision. In both of these patients, subsidence and femoral fracture caused aseptic loosening. Severe and unpredictable subsidence was common in that series; subsidence at the stem-cement interface averaged more than five millimeters in three patients (9 percent), and subsidence of the cement-graft composite averaged more than eleven millimeters in twelve patients (35 percent). Although most patients had good relief of pain at rest, relief of pain during the performance of a number of typical daily activities was inconsistent. This finding allows for the possibility of a relationship between subsidence and the typically painful clinical manifestations of loosening, although this was not proved statistically in that report. Finally, in this series, patients were selected for the procedure on the basis of severe femoral bone loss. This undoubtedly contributed to the high combined rate of femoral perforation and fracture (eight of thirty-four patients; 24 percent), but it may better reflect contemporary practice, as most centers now reserve impaction grafting for femora with severe bone loss.

Stems That Have a Rough Surface Finish
Very limited data are available on the use of implants other than polished, tapered stems for the performance of this technique. Kärrholm et al.15 presented a brief report on impaction allografting with the Spectron EF stem (Richards, Memphis, Tennessee) in a consecutive series of twenty-two femoral revisions. The Spectron EF stem is trapezoidal and longitudinally tapered, with a roughened proximal surface and a matte finish distally. Survivorship analysis in a large registry study demonstrated good long-term results23. Although they indicated that there were no clinical failures at two years, Kärrholm et al. did not focus on clinical results. Instead, all patients were examined radiostereometrically to assess subsidence and with dual-energy x-ray absorptiometry to assess reconstitution of bone stock. These techniques vastly improve the reliability of radiographic interpretation, which is notoriously subjective in these cases15,17. Dual-energy x-ray absorptiometry demonstrated increased bone density in most patients, suggesting some measure of reconstitution of corticocancellous bone stock. Radiostereometric analysis showed an average of only 0.4 millimeter of subsidence of the Spectron EF stems, which was much lower than that observed with polished, tapered stems. Three (14 percent) of the twenty-two patients, however, had progressive subsidence of as much as ten millimeters15. Although no revisions had been performed, Malchau22 indicated that he believed that those patients were at high risk for failure.

Precoated, Collared Stems
As impaction grafting is, on one level, a means of achieving fixation between the stem and viable bone with cement11, and in view of the two independent clinical series that raised concerns about the frequency and amount of subsidence observed with the double-tapered stem6,26, we chose to investigate impaction grafting with use of a precoated, collared, straight stem19 that has been proved durable in femoral reconstruction with cement3,30.

In this series, we reviewed the results for twenty-nine patients at a minimum of forty-eight months (mean, sixty-three months) postoperatively, which, to the best of our knowledge, is the longest duration of follow-up reported for this technique19. Most patients were selected for impaction grafting because they had severe femoral bone loss. Reliable relief of pain and improvement in function were achieved, with hip scores improving from a mean of 54 (of 100) points preoperatively to a mean of 87 points at the time of the most recent follow-up; twenty-one (91 percent) of the twenty-three patients who had not had revision had a good or excellent score at the time of the most recent follow-up. Of twenty-five hips that were available for radiographic review, two (8 percent) had aseptic failure due to symptomatic subsidence and one (4 percent) (in a patient receiving dialysis) had late infection. Kaplan-Meier survivorship analysis14 with aseptic radiographic or clinical failure as the end point revealed a survival rate of 92 percent at six years. Clear radiographic evidence of incorporation of the bone graft or cortical reconstitution was observed in six (24 percent) of the twenty-five patients; this rate is much lower than those reported in studies of impaction grafting with use of different femoral stems6,7,11,26 (Figs. 1-A, 1-B, 1-C, 1-D, 1-E, 1-F and 1-G). Despite this finding, the fact that more than 90 percent of the stems remained radiographically stable at a mean of more than five years supports the possibility that bone-healing, although not visualized on plain radiographs, was occurring. That possibility is supported by the findings in a series in which two of four patients who had histological evidence of healing after impaction grafting had no visible changes on plain radiographs29. The rate of operative complications in our series was similar to that in others in which the patients were selected for this technique on the basis of poor bone stock26.



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Figs. 1-A through 1-G: Impaction allografting for femoral revision with use of a textured, polymethylmethacrylate-precoated stem inserted with cement. Fig. 1-A: Preoperative radiograph demonstrating aseptic loosening of a cemented stem with severe metaphyseal bone loss, diaphyseal widening, and thinning of cortical bone.

 


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Figs. 1-B and 1-C: Radiograph, and enlarged section to show detail, made seven weeks postoperatively. The overall alignment of the stem and the cement technique are satisfactory.

 


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Figs. 1-B and 1-C: Radiograph, and enlarged section to show detail, made seven weeks postoperatively. The overall alignment of the stem and the cement technique are satisfactory.

 


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Radiograph, and enlarged section to show detail, made six months postoperatively. Some remodeling of the cancellous allograft is evident, and the alignment of the stem is unchanged.

 


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Radiograph, and enlarged section to show detail, made six months postoperatively. Some remodeling of the cancellous allograft is evident, and the alignment of the stem is unchanged.

 


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Follow-up radiograph, and enlarged section to show detail, made fifty-one months postoperatively. The stem is stable, with no measurable subsidence. The cancellous allograft has remodeled further and shows signs of healing to cortical bone.

 


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Follow-up radiograph, and enlarged section to show detail, made fifty-one months postoperatively. The stem is stable, with no measurable subsidence. The cancellous allograft has remodeled further and shows signs of healing to cortical bone.

 


    Problems and Complications of Impaction Allografting
 Top
 Introduction
 Clinical Results of Impaction...
 Problems and Complications of...
 Algorithm for Femoral...
 References
 

General Complications
Impaction allografting is one of the more technically demanding types of femoral reconstruction, as the frequency of complications in reported series reflects. Rates of dislocation have typically ranged from 3 to 6 percent (two of sixty7 to two of thirty-five patients25), and rates of infection have been similar; most reoperations have been performed for the treatment of periprosthetic fracture11,25,26, although hardware-related trochanteric bursitis19 and recurrent dislocation7 also have necessitated additional procedures. Deep-vein thrombosis and heterotopic ossification have been reported rarely7,11,19,26. It is not known whether the prevalence of these problems would differ with other techniques of femoral reconstruction, as no control studies have compared impaction grafting with other reconstructive methods, to our knowledge. However, the prevalence of nonunion after the osteotomy of the greater trochanter seems high with impaction grafting, ranging from six of eighteen19 to three of six patients26. This prevalence may be related to insufficient proximal bone stock or to the presence of cement interposed in the osteotomy site.

Femoral Fracture and Perforation
These complications are so common and potentially destructive that, in the context of femoral revision with impaction allografting, they merit separate consideration. To our knowledge, every report on this technique that includes a section on complications lists several cases of femoral fracture or perforation; the prevalence has ranged from 5 to 24 percent (three of sixty to eight of thirty-four patients)7,11,19,25,26, with higher rates in series in which patients were selected for impaction grafting on the basis of loss of femoral bone-stock19,25,26.

Intraoperative fracture usually occurs during the vigorous process of impaction required to obtain a stable neo-endosteum26. The cortical shell should be reinforced with either cortical strut-grafting7,26 or synthetic mesh11 if the integrity of the cortex is in question. Intraoperative perforation of the femoral shaft typically occurs during the removal of the cement, and, if recognized, it is easily treated with cortical strut allografts5. Postoperative fracture of the femur may occur about the stem tip7 or more proximally26. It may be related to unrecognized intraoperative femoral perforations or fractures or to unappreciated areas of osteolysis. Intraoperative and postoperative fractures have been associated with failure of the arthroplasty in several reports11,26. Even if it does not lead to revision, postoperative fracture almost invariably leads to a reoperation7,11,25,26, which poses risks that include additional blood loss and delayed rehabilitation.

Subsidence
The importance of subsidence of a stem (Figs. 2-A and 2-B) inserted with impaction grafting is the subject of considerable debate. Initial reports by Gie et al.7,11 claimed that the geometry of the wedge-shaped stem may improve incorporation and healing of the bone graft by the compressive load produced by the subsiding stem. Several reports on impaction grafting with use of polished, tapered stems also suggested that subsidence does not imply incipient clinical failure7,9,11. The effect of subsidence on the clinical result may be specific to the type of implant: in our series of precoated implants, both of the devices that subsided went on to clinical failure19. Subsidence of roughened or precoated stems inserted with cement is commonly used as an indicator of aseptic loosening3,13,30. However, subsidence even of polished, tapered stems may not be benign. Subsidence of these devices was thought to occur because of so-called cold flow of the cement, which supposedly allows the wedge-shaped stem to self-tighten as it subsides7,9,11. More recent reports have shown that this does not always occur; Masterson et al.25 found a high prevalence of early fractures of the cement around stems that subsided, which speaks against cold flow as the mechanism of migration of the implant. The authors of another study used radiostereometric analysis to arrive at the same conclusion10. Subsidence may continue for an unpredictable period of time postoperatively26, and it has been convincingly associated with pain in the thigh6 and prosthetic dislocation25.



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Figs. 2-A and 2-B: Impaction allografting for femoral revision with use of a polished, tapered stem. (Radiographs courtesy of Philip M. Faris, M.D., Orthopaedic Medicine of Indiana.) Fig. 2-A: Early postoperative radiograph made after revision of the femoral stem with impaction grafting. A cortical strut allograft with cerclage wires was placed because of an intraoperative perforation of the femoral shaft.

 


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Fig. 2-B: Follow-up radiograph demonstrating more than one centimeter of subsidence of the stem. This is best observed by comparing the relationship of the stem tip to the cerclage wires or by noting the position of the superolateral corner of the prosthesis compared with the tip of the greater trochanter.

 
The importance of subsidence, in particular of polished, tapered stems, is not yet known. Subsidence has historically been used as a marker for aseptic loosening3,13,30, but, with these particular devices, that use may not be universally valid. However, the contention that subsidence at any of several interfaces is benign9,11 needs to be validated with use of objective outcome tools such as standardized rating scales for pain and function or in clinical series from health-care systems where access to a revision procedure is reasonably available.

Radiographic Analysis
In nearly every clinical study of impaction grafting of which we are aware, histological healing or incorporation of the cancellous allograft has been inferred from plain radiographs7,11,26. To our knowledge, the largest series in which biopsy was performed after impaction grafting included four hips29, all of which demonstrated bone-healing histologically. Radiographs of two of the femora had suggested incorporation of the graft, whereas radiographs of the other two did not visibly reflect the histological findings. Radiographic inferences of bone-healing in these patients should therefore be made with caution.

Several groups have commented on the difficulty of reproducibly interpreting radiographs that show overlapping heterotopic bone, wire mesh, cortical bone, cortical allograft, bone cement, cancellous allograft, and the femoral prosthesis5,11. We are not aware of any studies that validated the grading system advocated by the group that popularized the technique of impaction grafting11; the system accounts for seven possible radiographic appearances of the cancellous allograft alone. A single study that examined the classification systems used to describe femoral deformity before revision of the hip showed poor intraobserver and interobserver reliability17.

Cost
To the best of our knowledge, no studies have systematically examined cost or charges paid by the patient in association with impaction allografting. This procedure certainly requires more labor, time, and supplies than does femoral revision performed with use of either cement alone or a long, fully coated stem. One study, published in 1997, broadly outlined the material costs of impaction allografting at the institution where it was performed: two femoral head allografts cost 1900 dollars, the CPT stem averaged 2000 dollars during the study period, and cortical strut allografts (several of which were often used) were 500 dollars each26. Time alone will tell whether these charges will be justified by a reconstruction that is more durable than can be provided with more modest means2,8,18.


    Algorithm for Femoral Reconstruction
 Top
 Introduction
 Clinical Results of Impaction...
 Problems and Complications of...
 Algorithm for Femoral...
 References
 
Currently, we use the following algorithm for femoral revision (Fig. 3). Once infection has been ruled out, both metaphyseal and diaphyseal bone stock are assessed. If there is minimum disruption of the metaphyseal bone stock and the diaphysis is intact, a partially coated stem is inserted either with or without cement. If there is more severe femoral bone loss, but the diameter of the canal is eighteen millimeters or less and it is determined intraoperatively that at least four to six centimeters of intact diaphyseal bone is available for distal fixation with good rotational stability, a six or eight-inch (fifteen or twenty-centimeter) extensively coated stem designed to be inserted without cement is used; this reconstruction is associated with excellent intermediate to long-term results2,8,18. At present, we reserve impaction allografting for patients for whom standard distal fixation without cement is not suitable, patients in whom restoration of proximal bone stock is particularly important, and patients in whom proximal stress-shielding and pain in the thigh from modulus mismatch are major concerns. These conditions are typically seen in patients who have a large (at least twenty millimeters in diameter), patulous, ectatic diaphysis and in whom less than four centimeters of diaphysis is usable for press-fit and rotational stability of a large, extensively coated stem is not possible. In this setting, alternatives to impaction allografting, which are more appealing for elderly or debilitated patients, include replacement of the proximal aspect of the femur and reconstruction with an allograft-prosthetic composite.



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Fig. 3 Algorithm favored by us to help to select the appropriate revision procedure for patients who have loosening of the femoral component.

 
Impaction allografting appears to provide satisfactory short to intermediate-term clinical results7,11,19, but important concerns remain regarding the frequency of major complications such as fracture or perforation of the femur19,25,26 and severe subsidence25,26. In view of the excellent long-term results that have been achieved with extensively coated implants designed to be inserted without cement2,8,18, we currently use impaction allografting for femoral revision only in patients who have very severe bone loss.


    Footnotes
 
*Printed with permission of the American Academy of Orthopaedic Surgeons. This article will appear in Instructional Course Lectures, Volume 49, American Academy of Orthopaedic Surgeons, Rosemont, Illinois, March 2000.

{dagger}No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article. No funds were received in support of this study.

{ddagger}The views expressed in this article are those of the authors and do not reflect the official policy of the United States Department of Defense or the United States Government.

§Section of Orthopaedic Surgery, William Beaumont Army Medical Center, 5005 North Piedras Street, El Paso, Texas 79920-5001.

#Midwest Orthopaedics at Rush-Presbyterian-St. Luke's Medical Center, 1725 West Harrison Street, Suite 1063, Chicago, Illinois 60612.


    References
 Top
 Introduction
 Clinical Results of Impaction...
 Problems and Complications of...
 Algorithm for Femoral...
 References
 

  1. Allan, D. G.; Lavoie, G. J.; McDonald, S.; Oakeshott, R.; and Gross, A. E.: Proximal femoral allografts in revision hip arthroplasty. J. Bone and Joint Surg., 73-B(2): 235-240, 1991.
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  4. Chandler, H.; Clark, J.; Murphy, S.; McCarthy, J.; Penenberg, B.; Danylchuk, K.; and Roehr, B.: Reconstruction of major segmental loss of the proximal femur in revision total hip arthroplasty. Clin. Orthop., 298: 67-74, 1994.
  5. Duncan, C. P.; Masterson, E. L.; and Masri, B. A.: Impaction allografting with cement for the management of femoral bone loss. Orthop. Clin. North America, 29: 297-305, 1998.[Medline]
  6. Eldridge, J. D.; Smith, E. J.; Hubble, M. J.; Whitehouse, S. L.; and Learmonth, I. D.: Massive early subsidence following femoral impaction grafting. J. Arthroplasty, 12: 535-540, 1997.[Medline]
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  8. Engh, C. A.; Glassman, A. H.; Griffin, W. L.; and Mayer, J. G.: Results of cementless revision for failed cemented total hip arthroplasty. Clin. Orthop., 235: 91-110, 1988.
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  17. Kerry, K.; Campbell, D.; Garbuz, D.; Masri, B.; and Duncan, C.: Classification systems for bone loss in revision THA—an exercise in imprecise precision? Read at the Annual Meeting of the Hip Society, London, Ontario, Canada, Sept. 26, 1998.
  18. Lawrence, J. M.; Engh, C. A.; Macalino, G. E.; and Lauro, G. R.: Outcome of revision hip arthroplasty done without cement. J. Bone and Joint Surg., 76-A: 965-973, July 1994.[Abstract/Free Full Text]
  19. Leopold, S. S.; Berger, R. A.; Rosenberg, A. G.; Jacobs, J. J.; Quigley, L. R.; and Galante, J. O.: Impaction allografting with cement for revision of the femoral component. A minimum four-year follow-up study with use of a precoated femoral stem. J. Bone and Joint Surg., 81-A: 1080-1092, Aug. 1999.[Abstract/Free Full Text]
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