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The Journal of Bone and Joint Surgery 80:910-22 (1998)
© 1998 The Journal of Bone and Joint Surgery, Inc.

Instructional Course Lecture

Instructional Course Lectures, The American Academy of Orthopaedic Surgeons - Evaluation and Treatment of Infection at the Site of a Total Hip or Knee Arthroplasty*{dagger}

ARLEN D. HANSSEN, M.D.{ddagger}, ROCHESTER, MINNESOTA and JAMES A. RAND, M.D.§, SCOTTSDALE, ARIZONA

An Instructional Course Lecture, American Academy of Orthopaedic Surgeons


   Introduction
Top
 Introduction
Etiology
 Infection at the Site...
 References
 
Infection following total joint replacement remains a major problem that has not been solved during the last thirty years. The prevalence of infection at the Mayo Clinic between 1969 and 1996 was 1.7 per cent of 30,680 total hip arthroplasties and 2.5 per cent of 18,749 total knee arthroplasties. After primary operations, the rate of infection was 1.3 per cent of 23,519 hips and 2.0 per cent of 16,035 knees. After revision operations, the rate was 3.2 per cent of 7161 hips and 5.6 per cent of 2714 knees (Table I). The rate of infection has been remarkably constant despite the use of different regimens of antibiotic prophylaxis, operating-room configurations, operative techniques, and modes of fixation of the implant. Factors leading to deep infection must be considered with respect to the host, wound, operative technique, operating-room environment, and microbiological characteristics of the infecting organisms. A prompt diagnosis of infection will facilitate treatment and minimize morbidity.


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  		TABLE I PREVALENCE OF INFECTION AFTER TOTAL JOINT ARTHROPLASTY FOR THE YEARS 1969 THROUGH 1996

 


   Etiology
Top
 Introduction
 Etiology
Infection at the Site...
 References
 
As stated, in discussing the etiology of infection, the host, wound, operating-room environment, operative technique, and microbiological characteristics of the infecting organisms must be considered. The patient as host is an important risk factor for infection. The operative wound is contaminated to some extent in all procedures, but the immune-defense mechanisms of the host prevent infection in most instances. Immunocompromised patients are clearly at increased risk for deep infection as are patients who have rheumatoid arthritis110,140. In a series of 4171 total knee replacements, an infection developed after sixteen (0.9 per cent) of 1854 replacements in patients who had osteoarthrosis compared with forty-five (2.2 per cent) of 2076 replacements in those who had rheumatoid arthritis140. In a series of 4240 total hip, knee, and elbow arthroplasties, the rate of infection was 2.6 times greater in patients who had rheumatoid arthritis than it was in those who had osteoarthrosis110. In one study, seventeen (4 per cent) of 425 male patients with polyarticular rheumatoid arthritis had an infection following total knee replacement140. In another study, male patients who had polyarticular rheumatoid arthritis were found to be at risk for more than one infection: of 145 patients who had an infection following total joint replacement, twenty-seven (19 per cent) had a subsequent infection and nineteen of those twenty-seven patients had a diagnosis of rheumatoid arthritis80.

Patients who have diabetes mellitus also are at increased risk for deep infection. In a series of sixty-six knees in forty-six diabetic patients (six of whom were lost to follow-up, leaving fifty-nine knees in forty patients), four knees (7 per cent) became infected after total knee arthroplasty30. The increased rate of infection was associated with complications related to wound-healing in eight (12 per cent) of the original sixty-six knees. In another study, of sixty-eight knees in fifty-one patients with diabetes mellitus who were followed for eight years after a total knee arthroplasty, there were twenty-one complications (31 per cent); in a matched-case group consisting of sixty-eight knees, two (3 per cent) became infected104. In a third study, the rate of infection following total hip arthroplasty in forty-four patients (sixty-two hips) who had diabetes mellitus was 6 per cent, which was significantly higher than the rate in non-diabetic osteoarthrotic patients (p < 0.001) and non-diabetic rheumatoid patients (p < 0.01)87. However, in a fourth study, of ninety-three total hip arthroplasties in patients with diabetes mellitus who were followed for four years, there were no infections90.

Poor nutrition is another factor influencing deep infection. It was reported that wound complications occurred more frequently in patients with malnutrition as indicated by a total lymphocyte count of less than 1500 per cubic millimeter (1.5 x 109 per liter) or a serum albumin level of less than 3.5 grams per deciliter (thirty-five grams per liter)40,59,131. In a study of 103 total hip arthroplasties, a serum transferrin level of less than 226 milligrams per deciliter (2.26 grams per liter) was the only variable indicating malnutrition that was significantly associated with delayed wound-healing (p < 0.002)37.

Other risk factors for deep infection include obesity, urinary-tract infection, and oral use of steroids140. In a series of 182 total knee arthroplasties in obese patients, there were no infections132. Deep infection developed after total knee arthroplasty in four (17 per cent) of twenty-four knees in patients who had psoriasis133.

A previous operation on the affected joint increases the rate of deep infection as much as twofold after total knee arthroplasty and as much as threefold after total hip arthroplasty112,134. Wilson et al. noted that the rate of infection in patients who had osteoarthrosis was 1.4 per cent when the affected knee had been operated on previously compared with 0.3 per cent when it had not140. Poss et al. reported an eightfold increase in the risk of infection in patients who had had a revision compared with those who had had a primary total hip arthroplasty110. In a study of 3215 total hip arthroplasties, infection was found to be related to a previous operation, a prolonged operative time, positive intraoperative cultures, or an unrecognized preoperative infection34. In a study of sixty-five knee replacements in patients who had had a previous knee infection, the overall risk of infection was 8 per cent (five knees), with two (4 per cent) of forty-five knees that had had septic arthritis and three (15 per cent) of twenty that had had osteomyelitis becoming infected60. A study of 3051 total hip arthroplasties revealed a significantly (p < 0.001) increased risk of infection in patients who had had a revision of a previous arthrodesis or had a history of infection126.

Particles of debris, advanced age, and prolonged preoperative hospitalization also are potential risk factors for infection. In a series of 23,649 general surgical patients, the rate of infection was 1.1 per cent for patients who had been admitted to the hospital on the day of the operation compared with 4.3 per cent for those who had been hospitalized for two weeks before the operation (no numbers were given)23.

Any active site of concurrent infection may allow hematogenous seeding of the operative site. In a consecutive series of 803 total hip arthroplasties, the rate of infection was threefold greater in patients who had a concurrent remote infection than in those who did not134.

The type of reconstruction also influences the risk of deep infection. Large, hinged total knee implants have been associated with rates of infection ranging from seventeen (11 per cent) of 156 to eight (16 per cent) of fifty110,113. In a study of 659 hips that had a total hip arthroplasty, four (3 per cent) of 125 that had had the procedure with use of structural bone graft had an infection compared with one (0.2 per cent) of 534 that had not128. All procedures were performed with use of prophylactic antibiotics, vertical laminar airflow, and helmet aspirator suits.

The operating-room environment is an important factor that influences contamination of the operative wound. Variables affecting the operating room include the number of personnel, the amount of traffic, the preparation of the operative site, the use of airflow, and the dress of the surgical team. The major source of bacteria within the operating room is people. In one study, the number of colony-forming units was thirty-fourfold greater when the room was occupied than when it was empty118. Some individuals shed a large number of bacteria119. Exclusion of such individuals and minimization of the number of people in the room decrease the potential for contamination of the wound. The use of a helmet aspirator suit can decrease bacterial environmental air settle-plate counts in the operating room compared with those associated with use of a standard gown and hood (p < 0.005)119. A helmet aspirator suit should be worn by individuals in the operating room who shed an increased number of bacteria. Such a suit also is useful in preventing contamination of the operative team by blood from the operative site as such blood may contain human immunodeficiency virus, hepatitis virus, or infectious bacteria130. The suit also can prevent contamination of the operative wound by fragments of cement that strike the surgeon during removal and fall into the wound during a revision.

The use of standard operating-room clothing and gowns is less effective in preventing contamination than the use of a polypropylene coverall12,117. Even in an ultraclean-air operating room, bacterial counts were 4.4 times higher during preparation and draping of the wound by an unscrubbed, ungowned assistant and 2.4 times higher during preparation and draping by a gowned assistant than they were intraoperatively15. Shaving and preparation of the operative site should be performed immediately before the operation as areas of skin damage may harbor bacteria. A wide variety of skin-cleaning agents are effective for preparation of the operative site119. In one study, use of an iodophor-incorporated drape during 649 total knee arthroplasties was associated with a rate of infection of only 0.5 per cent (three infections)116. In another study, use of an iodophor-incorporated drape was significantly (p = 0.05) better than other methods of skin-site preparation in preventing recolonization of the skin by bacteria61. Other variables that increase the potential for contamination of the operative wound include use of a splash basin to wash or store instruments, prolonged use of a suction tip, and perforations in gloves4,41,124.

The role of laminar airflow in controlling infection has remained controversial. Lidwell et al., in a multicenter study, reported that infection developed after sixty-three of 4133 hip and knee arthroplasties performed in a conventional operating room compared with twenty-three of 3923 such procedures performed in a room with laminar airflow75. Infection developed in thirty-four of 5831 hips in patients who had antibiotic prophylaxis compared with fifty-two of 2221 hips in patients who did not75. However, the prophylactic use of antibiotics was not strictly controlled. The data reported by Lidwell et al. suggest a combined beneficial effect of laminar airflow and prophylactic antibiotics74,75. Charnley found that the rate of infection after total hip arthroplasty decreased from 3.1 per cent of 1080 when laminar airflow was not used to 1.4 per cent of 909 when it was19. Other investigators have also reported that laminar airflow decreases the prevalence of infection13,38,85,97. Ritter et al. attributed this decrease to a 92 per cent reduction in bacteria within the clean-air area117. Laminar airflow appears to diminish the prevalence of contamination of the surgical instruments while they are exposed on the instrument table118.

The effect of laminar airflow during hip arthroplasty may be different from that during knee arthroplasty. In one study, the rate of infection after hip arthroplasty decreased, from eleven (1.4 per cent) of 761 hips to thirteen (0.9 per cent) of 1518 hips, when laminar airflow had been used; however, the rate of infection after knee arthroplasty increased, from eight (1.4 per cent) of 573 knees to twelve (3.9 per cent) of 310 knees, when laminar airflow had been used123. This difference was thought to be related to the positioning of the operating-room personnel between the airflow and the operative wound during the knee arthroplasties.

Another approach that has been employed to control the operating-room environment is the use of ultraviolet light. Lowell et al. reported that the rate of infection was 0.5 per cent of 1712 hips when arthroplasty was performed in an operating room equipped with ultraviolet light compared with 3 per cent of 621 hips when the procedure was performed in a conventional operating room79. As demonstrated by continuous air-sampling adjacent to a total hip-arthroplasty incision, use of a combination of ultraviolet light and occlusive clothing decreased the number of colony-forming units per cubic meter to 0.5 compared with 7.7 with use of laminar airflow10.

The operative technique is an important variable that influences the potential for deep infection. Meticulous handling of tissue is necessary to minimize devitalization and hematoma. An increased operative time has been reported to be associated with an increased risk of infection19. The operative time should be minimized to decrease the time for potential contamination of the wound. Previous incisions should be utilized to prevent areas of skin necrosis between an old and a new incision. Whenever there is a need to reoperate because of persistent drainage, a hematoma, or an area of wound necrosis, there is an increased risk of deep infection. Brown et al. found that hips with a history of drainage after an operation had a 3.2 times higher risk of infection than those that had healed normally15. Therefore, meticulous hemostasis and wound closure are essential.

The microbiology of deep infection as well as the interactions among biomaterials, the patient, and contaminating microorganisms must be considered. Microorganisms that may be responsible for infection at the site of a total joint arthroplasty include aerobic and anaerobic organisms, fungi, mycobacteria, and Brucella1,48. An inability to identify the organism causing some clinical infections may be due to failure to culture for fastidious organisms or it may be due to the fact that the organism was suppressed by previous treatment with antibiotics. The most frequent pathogenic organisms are Staphylococcus aureus and Staphylococcus epidermidis. However, each hospital must constantly review the types of organisms causing infection as these may change over time. Antibiotic prophylaxis must be directed at the most common pathogens in each hospital setting. The increasing frequency of infections caused by organisms such as methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus species, which are generally resistant to more than one antibiotic, provides a dilemma with regard to prophylaxis and treatment.

There have been numerous experimental studies evaluating the susceptibility of the patient to infection adjacent to implant materials. Polymethylmethacrylate, stainless steel, cobalt-chromium alloy, and polyethylene all have been found to increase susceptibility to infection106-109,127. Polymethylmethacrylate, especially when polymerized in vivo, impairs the chemotaxis, phagocytosis, and killing ability of polymorphonuclear leukocytes107. The prosthesis, which acts as a large foreign body, provides a biomaterial that can be colonized by a contaminating microorganism. Biomaterials are surrounded by an immunoincompetent zone that predisposes to infection43. Bacteria have the ability to bind to biomaterials with use of physical forces, chemical binding, and specific receptors to surface proteins43. Staphylococcus epidermidis has a high rate of adhesion to polyethylene43. Bacterial resistance to antibiotics is related to the production of a glycocalyx slime that impairs antibiotic access and killing by host-defense mechanisms42-45,95. Recently, bacteria were found to persist in vitro on the surface of antibiotic-impregnated cement65. The presence of a glycocalyx can result in unreliable in vitro testing for the minimum inhibitory concentration of antibiotic that is needed to treat an infection. The more virulent organisms causing infection include methicillin-resistant staphylococci, gram-negative bacilli, group-D streptococci, enterococci, and organisms that elaborate a glycocalyx73. Less virulent organisms include methicillin-sensitive staphylococci, anaerobic cocci, and streptococci other than group D32.

The diagnosis of infection must begin with the careful recording of the history, which should include a search for host factors predisposing to infection or problems with wound-healing, and a physical examination, which should include an assessment of effusion, warmth, tenderness, and drainage. The only finding that is consistently associated with infection is pain33. Radiographs should be evaluated carefully for loosening of the implant, periosteal new-bone formation, periprosthetic bone resorption, and ectopic bone. The most consistent radiographic finding is progressive prosthetic loosening.

Hematological testing may include the white blood-cell count, the erythrocyte sedimentation rate, and the C-reactive protein level. However, neither the white blood-cell count nor the erythrocyte sedimentation rate is consistently elevated in the presence of deep infection33,49. In a series of seventy-two infections at the sites of total joint arthroplasties, the erythrocyte sedimentation rate had a sensitivity of 60 per cent and a specificity of 65 per cent73. The C-reactive protein level is generally elevated initially after an uncomplicated total hip arthroplasty, returning to normal within three weeks99,129. The C-reactive protein level is normal in patients who have mechanical loosening but remains elevated in those who have septic loosening129.

Bone scans may be of the technetium-99, indium-111 white blood-cell, monoclonal antibody, or polyclonal antibody type. The technetium-99 scan has been used widely but is very non-specific. Levitsky et al., in a series of seventy-two total joint arthroplasties, reported a sensitivity of 33 per cent, a specificity of 86 per cent, a positive predictive value of 30 per cent, and a negative predictive value of 88 per cent73. In a series of thirty-eight knees that had been painful following a total knee arthroplasty and had been evaluated with use of indium-111 white blood-cell scans before a reoperation, the accuracy of the scans was 84 per cent, the sensitivity was 83 per cent, and the specificity was 85 per cent111. In a series of ninety-two total hip arthroplasties that had been performed with cement, use of a technetium-99m-sulfur colloid scan in addition to an indium-111 leukocyte scan improved sensitivity to 100 per cent, specificity to 97 per cent, and accuracy to 98 per cent103. Indium-111 polyclonal antibody scans provided a sensitivity, specificity, and accuracy of 100 per cent in a series of twenty-five patients101, and they provided a sensitivity of 98 per cent and a specificity of 94 per cent for twenty-five patients in another series24; however, the use of these scans was not specifically studied with respect to total joint arthroplasty24,101. Monoclonal antibody scans utilized for imaging of bones and joints had a sensitivity of 90 per cent, a specificity of 85 per cent, and an accuracy of 88 per cent in a series of fifty-three patients8, and they had a sensitivity of 93 per cent, a specificity of 89 per cent, and an accuracy of 90 per cent in sixty-two patients in another series47.

Aspiration of the joint has been controversial. Studies of the aspirate should include culture, determination of the glucose level in synovial fluid, and a cell count. In a series of seventy-two infections at the sites of joint arthroplasties, aspiration had a positive predictive value of 75 per cent and a negative predictive value of 94 per cent73. Barrack and Harris found that cultures of material aspirated from the hip were positive for six of ten infected hips and thirty-four of 291 non-infected hips7. Lachiewicz et al., in a study of aspiration performed before 193 revision total hip arthroplasties, found an accuracy of 96 per cent, a specificity of 97 per cent, and a sensitivity of 92 per cent68. Those authors recommended aspiration if the prosthesis had been in place for less than five years and the erythrocyte sedimentation rate was abnormal68. In another study, aspiration of sixty-four knees before revision had a sensitivity and specificity of 100 per cent26. Polymerase chain-reaction testing may provide increased sensitivity for the diagnosis of infection, but it also may increase the number of false-positive results83.

Pathological evaluation of tissue at the time of the operation may be necessary to confirm infection in difficult cases. Tissue should be obtained from the bone-cement or prosthesis-bone interface as well as from abnormal-appearing areas of synovial tissue. Five polymorphonuclear leukocytes per high-power field has been recommended as the criterion for the diagnosis of infection89. In a study of knee arthroplasty, there was pathological evidence of acute inflammation in fourteen of fifteen knees that were infected and in one of forty knees that were not infected26. In a series of thirty-three total hip and knee revisions, the sensitivity of analysis of frozen sections was 100 per cent and the specificity was 96 per cent31.

Therefore, a high index of suspicion is necessary for the diagnosis of infection following total joint arthroplasty. It is essential that a careful history be obtained to assess host risk factors and wound-healing. Physical examination of the affected joint, with assessment of the skin, effusion, and tenderness, should be performed. High-quality radiographs must be examined for areas of loosening and bone resorption. Ancillary evaluation with hematological tests, bone scans, and aspiration of the joint can provide additional information about selected patients. A final decision at the time of the revision may need to be made on the basis of the findings of pathological evaluation of tissue. There is no single test that can reliably predict a diagnosis of infection in all patients. The use of combined studies often can provide a reasonable indication of the probability of infection.


   Infection at the Site of a Total Hip Arthroplasty
Top
 Introduction
 Etiology
 Infection at the Site...
References
 
Options for the treatment of infection at the site of a total hip arthroplasty include long-term antibiotic suppression, débridement with retention of the prosthesis, definitive resection arthroplasty, arthrodesis, and reinsertion of another prosthesis (reimplantation)35. When feasible, reimplantation is generally the most desirable method of treatment for most patients as it has been associated with improved functional outcome and greater patient satisfaction. Contraindications to reimplantation include persistent infection; medical conditions preventing multiple operative procedures; severe soft-tissue damage, such as absent function of the abductor muscles or limited skin or muscle over the hip; and systemic conditions that highly predispose toward reinfection.

The central controversies with regard to reimplantation involve aspects of antibiotic therapy, such as use of local antibiotic-delivery systems; the proper time-interval between removal of the prosthesis and reimplantation; use of antibiotic-impregnated bone cement for fixation of the prosthesis; use of a prosthesis inserted without cement; and use of bone graft, specifically structural allograft, for reconstruction. The small numbers of patients in most reports have hindered accurate analysis of these controversial treatment variables. Furthermore, differences in outcome between older and more contemporary series may reflect differences in ancillary treatment modalities. Finally, analyses of the outcomes of treatment of infection following total hip arthroplasty should not include patients who have an endoprosthesis or an internal fixation device6,20,21,33,36,63,76,82,98. Cherney and Amstutz noted that "there was a higher infection rate in the patients who had had an infection following a prior total hip-joint replacement.... Infections following internal fixation of fractures or from hematogenous spread may be more readily curable."20

In the analyses that follow, only patients who had an infection at the site of a hip prosthesis are included when multiple series are combined to assess the effect of different treatment variables.

Antibiotic Therapy
The primary controversies with respect to antibiotic therapy include the duration and route of administration and the efficacy of local delivery systems.

The optimum duration of antibiotic therapy has not been definitively established, and the use of antibiotic-impregnated cement has altered current recommendations. Although there are some general guidelines for the use of intravenous antibiotic therapy, there is no consensus on the proper use of oral antibiotic therapy for patients who have an infection at the site of a total hip arthroplasty. Recommendations have generally been for four to six weeks of intravenous administration; however, the reported durations have been extremely variable, ranging from zero to nine weeks of intravenous therapy and no oral therapy to more than two years of oral therapy17,18,55,88,93,121,125,141.

The most consistent results have been achieved with the duration of antibiotic therapy that is included in a two-stage reimplantation protocol consisting of resection arthroplasty, six weeks of intravenous administration of antibiotics in doses that achieve a serum bactericidal titer of at least 1:8, and subsequent reinsertion of a new prosthesis76,121,122. By definition, the use of this strict protocol prevents comparison of different durations of antibiotic therapy, but its rate of success is persuasive, with reinfection developing in only three (9 per cent) of thirty-two hips76. Of four patients who had a bactericidal titer of less than 1:8, two had a reinfection; this rate of reinfection was significantly higher than the rate for the other twenty-eight patients (p = 0.035)76. Those authors stated that reimplantation is contraindicated if a bactericidal titer of at least 1:8 cannot be achieved. The importance of the serum bactericidal titer in that report may have been overstated as both patients who had an inadequate titer and a reinfection had a number of other confounding variables. Both had had a polymicrobial infection; one was elderly, with multiple medical problems; and the other had needed multiple débridements and transposition of the vastus lateralis muscle for wound-healing. Additionally, the use of gentamicin-impregnated beads in four patients and of antibiotic-impregnated bone cement for fixation of the prosthesis in seventeen patients potentially affected the authors' conclusion regarding the efficacy and necessity of serum bactericidal-titer testing76. Finally, the method for this type of testing is difficult to duplicate consistently within and between laboratories, and the minimum inhibitory concentration achieved with use of agar or broth dilution appears to be the best guide for antibiotic therapy120.

In another retrospective study, thirty-five patients received antibiotics intravenously for less than four weeks and forty-four, for four weeks or more82. The strength of this study is that the confounding variables of antibiotic-impregnated beads or spacers and antibiotic-impregnated cement for fixation of the prosthesis were not present. Although reinfection occurred in seven (20 per cent) of the thirty-five patients who had therapy for less than four weeks compared with four (9 per cent) of the forty-four who had therapy for four weeks or more, this difference was not found to be significant with the number of patients available for study (p = 0.19)82. Multivariate analysis of a subgroup of the patients who were infected with an organism that was determined to be more virulent revealed that three of seven who were managed for less than four weeks had a reinfection compared with only one of thirteen who were managed for four weeks or more. Again, with the numbers available, this difference was not found to be significant (p = 0.055), but these findings strongly suggest that at least four weeks of intravenous therapy is probably advisable.

Although many investigators have thought that gram-negative infections are more difficult to treat16,20,22,63, others have found no difference in the prevalence of reinfection with gram-negative organisms36,76,82,98. Some bacteria form an exopolysaccharide-glycocalyx slime that shields microbial growth from antibodies and antibiotics44. It has been suggested that, when colonization takes place on a surface, resistance to antibiotics is related to bacterial metabolic changes that are specific to the organism and the type of biomaterial substrate95. Comparisons of susceptibility to antibiotics between suspended bacteria and surface-adherent bacteria have revealed consistently higher minimum inhibitory concentrations for adherent bacteria, and this effect was greater when bacteria had adhered to bone cement than when they had adhered to polyethylene95. This varying susceptibility to antibiotics, based on the specific organism as well as the specific biomaterial, has extraordinary relevance to many treatment concepts. For example, the increased resistance of the infecting organism to antibiotics that is induced by surface adherence to a retained piece of bone cement is not accounted for by serum bactericidal-titer and minimum inhibitory-concentration testing as currently performed.

Although it has been traditionally accepted that intravenous administration of antibiotics is more effective than oral administration, there are several factors that may call this tenet into question. Many new antibiotics that are given orally are absorbed more effectively than older antibiotics, and several of these new agents are effective against organisms that previously could be treated only intravenously. Given good patient compliance and serum-testing to evaluate the efficacy of absorption, many investigators currently are interested in whether oral administration can replace portions of the therapy formerly reserved for intravenous administration. If this approach proves equally effective, the potential benefits will include a marked reduction in overall health-care costs. Efficacy studies currently are being performed to evaluate different combinations of orally administered antibiotics for the treatment of infections at the sites of orthopaedic implants25. Oral administration also can be used to supplement a course of intravenous administration, either for a defined period or for chronic long-term suppression.

Because there are not yet any established guidelines for the duration of oral antibiotic therapy, treatment must be individualized for each patient17,18,55,88,93,121,125,141. Many current drug trials are being performed to address the issue of the duration of oral administration. In general, the oral use of antibiotics for chronic suppression is reserved for elderly patients or for those in whom removal of the prosthesis would be prohibitively difficult. Also, the antibiotic must be relatively non-toxic and tolerated by the patient. If the patient is expected to live for a long duration, it is probably best to avoid prolonged oral therapy in order to prevent the emergence of multiresistant organisms, the formation of excessive scar tissue, and the progressive loss of bone stock.

Local Delivery of Antibiotics
The use of local antibiotic-delivery systems in the form of antibiotic-impregnated beads or spacers also has changed traditional regimens of intravenous antibiotic therapy. These delivery systems result in local levels of antibiotics that far exceed those attained with systemic antibiotic therapy. Despite remarkably high levels of antibiotics in adjacent cortical bone, the efficacy of antibiotic-impregnated cement in the treatment of infection at the site of a total hip arthroplasty has not been established with use of comparative clinical studies, to our knowledge; however, the clinical experience with antibiotic-impregnated cement has been widespread3,11,29,36,51,55,56,66,76,78,81,91,93,94,96,100,114,115,121,122,136-138,141,142. Several different factors, such as variability in the type and amount of antibiotic added to bone cement, probably account for the inability to demonstrate the efficacy of local delivery. Most of the commonly used antibiotics leach from a variety of different acrylic bone cements5,9,27,28,53,54,67,71,72,84. The antibiotics that are most frequently added to bone cement in the United States include tobramycin, gentamicin, and vancomycin51. It is important to note that some antibiotics should not be mixed with bone cement. Lincomycin and tetracycline are deactivated by the bone-cement polymerization process, and rifampin produces a black, tacky composite that does not harden for several days9,72.

There are many variables affecting elution of antibiotics from bone cement. Antibiotics elute in greater amounts and over more sustained time-intervals from Palacos bone cement than from Simplex-P, CMW, or Sulfix acrylic bone cement9,54. Most investigators have determined that vancomycin elutes effectively and maintains bioactivity after elution from bone cement9,67,71,105. The total elution of an antibiotic is highly dependent on the porosity and surface characteristics of the bone cement as well as on the type of antibiotic being used14,27,86,105. A combination of two antibiotics improves the elution of both agents105. Large amounts (as much as eight or nine grams) of antibiotic powder may be added to cement beads or spacers. However, only one to two grams of antibiotic powder per forty grams of cement is recommended for fixation of the prosthesis so as to avoid major mechanical weakening of the bone cement.

A distinct disadvantage of the use of cement beads about the hip joint is the extreme difficulty in removing these beads after approximately six weeks of implantation. Biodegradable antibiotic delivery systems that are currently under investigation should eliminate this problem. An alternative method is the use of antibiotic-impregnated spacers, which allows local delivery of antibiotics, minimizes limb-shortening, limits scar formation, and facilitates reimplantation27,56,100,142. (This method will be discussed later, in the section on delayed reconstruction.) However, the efficacy of this antibiotic-depot method has not yet been proved in a clinical trial. Additional investigation is necessary to elucidate the numerous issues related to antibiotic therapy.

Timing of the Reconstruction and Use of Antibiotic-Impregnated Bone Cement
The choice of operative technique (direct exchange or delayed reconstruction) is one of the principal decisions with regard to the treatment of infection at the site of a total hip arthroplasty. Potential advantages of direct exchange include less morbidity (because the need for resection arthroplasty is avoided), reductions in cost (because a second hospitalization and operative procedure are not needed), and avoidance of technical difficulties associated with delayed implantation. A distinct disadvantage of direct exchange is the inability to use bone cement mixed with specific antibiotics selected on the basis of cultures of tissue samples obtained intraoperatively. Some reports have detailed success of direct exchange as the final outcome of repeated exchanges16,77; however, the final outcome and total cost of initial treatment with direct exchange have not been fully elucidated. In contrast to direct exchange, delayed reconstruction allows observation of the patient's response to therapy. Disadvantages include the hardships associated with resection arthroplasty, technical difficulties, and the cost of a second operative procedure.

In a comparative study of direct exchange, reimplantation within four weeks (average, 2.1 weeks), and reimplantation delayed for more than four weeks (average, 12.7 weeks), the group that had two-stage early reimplantation had the best functional results, the lowest rate of mortality, and the best rate of resolution of the infection66. The primary interests of proponents of delayed reconstruction include determining the shortest acceptable delay between resection arthroplasty and reimplantation in order to minimize hardship to the patient, improving the functional results, and decreasing the difficulty of revision procedures while maintaining the lowest possible rate of reinfection.

Direct Exchange
To our knowledge, the largest reported experience with direct-exchange procedures involved 577 hips that were infected after a total hip arthroplasty16. The findings suggested that overall results can be improved by careful selection of patients, as gram-positive infections were associated with a better prognosis than were gram-negative infections. General contraindications to the direct-exchange technique included the presence of a gram-negative organism, an actively discharging sinus, or overt purulence at the time of revision16. In a study in which these strict selection criteria had been used and in which antibiotic-impregnated cement had been employed for fixation of the prosthesis, all thirty patients had had resolution of the infection at the time of follow-up, at two to eight years94. When these generally accepted criteria had not been used, in a study of direct exchange in fifty-seven hips that had an infection with a draining sinus at the site of a total arthroplasty, the rate of resolution of the infection was 86 per cent (forty-nine hips) at an average of seven years114.

The use of antibiotic-impregnated bone cement for fixation of the prosthesis seems to be quite important when the direct-exchange method is employed. A review of multiple series revealed that direct exchange with use of plain bone cement was successful in forty (60 per cent) of sixty-seven hips that had an infection after total hip arthroplasty20,57,58,63,70. These results are in marked contrast to the reported success rate of 1352 (83 per cent) of 1630 hips after use of antibiotic-impregnated cement3,16,18,29,36,52,55,58,62,66,77,78,88,92-94,114,125,137,141. Although the direct-exchange technique has been used far more commonly in Europe than in North America, if it is thought appropriate for an individual patient, use of strict preoperative selection criteria as well as antibiotic-impregnated cement for fixation of the prosthesis is strongly recommended. The ratio of antibiotics in bone cement that is needed for fixation of the prosthesis is not universally accepted. In a twelve-year survival analysis of 239 hip prostheses, there was no demonstrable difference with regard to mechanical loosening between hips in which a ratio of less than 2.5 grams of antibiotic per forty-gram batch of bone cement had been used and those in which a ratio of 2.5 to 4.5 grams per forty grams of cement had been used28. The current recommendation in North America is for 0.6 to 1.2 grams of tobramycin combined with 0.5 to 1.0 gram of vancomycin per forty-gram batch of bone cement27.

Delayed Reconstruction
The success that has been achieved with use of delayed-reconstruction techniques in the absence of antibiotic-impregnated bone cement strongly supports the concept that delayed reconstruction is an important variable. A review of multiple series of hips treated with delayed reconstruction and bone cement without antibiotics revealed that 130 (82 per cent) of 159 hips had a successful result at the time of the latest follow-up11,20,39,57,58,76,82,135,139. It is important to note that none of the patients in these series were managed with antibiotic-impregnated beads or spacers between the time of the resection arthroplasty and the reimplantation. A review of multiple series of patients managed with delayed reimplantation and use of antibiotic-impregnated cement for fixation of the prosthesis revealed that 354 (90 per cent) of 392 had a successful outcome3,18,28,36,50,55,56,76,93,125,136,142. A separate analysis of hips treated with antibiotic-impregnated beads or spacers for local delivery of antibiotics showed that a successful outcome was achieved in 174 (92 per cent) of 189 hips36,50,55,56,125,142. It is difficult to determine, from these data, whether local delivery of antibiotics has an independent beneficial effect. If reimplantation is being performed because of reinfection after a previous attempt at reimplantation for the treatment of infection, then delayed reconstruction with use of antibiotic-impregnated cement provides the best chance for a successful outcome102.

The prosthesis of antibiotic-loaded acrylic cement (PROSTALAC) was developed in an effort to reduce morbidity and decrease the technical difficulties associated with delayed reconstruction27,64,142. This concept is, in reality, a hybrid of direct exchange and delayed reconstruction. The prosthesis consists of a thin polyethylene acetabular component and a modular stainless-steel femoral endoskeleton coated with antibiotic-loaded cement, which acts as a local antibiotic-delivery system to maintain limb length and anatomical relationships and to facilitate mobility while the patient awaits definitive reconstruction. The rate of success with use of these implants has been encouraging; in one series, only three (6 per cent) of forty-eight hips had a reinfection142. The PROSTALAC implant merits further evaluation to explore the possibility of lower health-care costs as a result of the patient being more independent and having a higher level of function and to assess the effect of local delivery of antibiotics.

The timing of the reconstruction and the use of antibiotic-impregnated cement are two closely linked variables that exert an independent influence on the outcome of treatment of infection at the site of a total hip arthroplasty. The apparent effect of these two variables is demonstrated by a review of the results of multiple series (Fig. 1). In the absence of antibiotic-impregnated bone cement, the results of direct-exchange techniques are vastly inferior. However, when the reconstruction is performed after a delay following removal of the implant, the results obtained without use of antibiotic-impregnated cement are similar to those achieved with direct exchange with use of antibiotic-impregnated cement. Finally, although analyses based on combined series have major shortcomings, delayed reconstruction combined with use of antibiotic-impregnated bone cement appears to provide the highest rate of success of treatment of infection at the site of a total hip arthroplasty.



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  		Fig. 1 Bar graph showing the effects of the timing of the reconstruction and the use of antibiotic-impregnated bone cement. Combination of the results from multiple series reveals that delayed reconstruction and antibiotic-impregnated bone cement exert independent, beneficial effects on the outcome of reimplantation performed because of infection at the site of a total hip arthroplasty. 1 = direct exchange with bone cement without antibiotics20,57,58,63,70, 2 = direct exchange with antibiotic-impregnated cement3,16,18,29,36,52,55,58,62,66,77,78,88,92-94,114,125,137,141, 3 = delayed reconstruction with bone cement without antibiotics11,20,39,57,58,76,82,135,139, 4 = delayed reconstruction with insertion of the prosthesis without cement11,46,69,98,138,139, and 5 = delayed reconstruction with antibiotic-impregnated cement3,18,28,36,50,55,56,76,93,125,136,142.

 

Insertion of the Prosthesis without Cement
Studies have demonstrated deleterious effects of bone cement on chemotaxis, phagocytosis, and opsonization of leukocytes in humans and higher rates of infection with use of polymethylmethacrylate than with use of other biomaterials in canine models60-62. Accordingly, the results of reimplantation of prostheses without cement have been investigated. When several series in which this approach was used are combined, the rate of successful eradication of infection is found to be 109 (87 per cent) of 126 patients11,46,69,98,138,139. The use of antibiotic-impregnated beads in the interval between resection arthroplasty and reimplantation yielded a successful result in fifty-one (88 per cent) of fifty-eight patients46,69. Again, it is difficult to determine, on the basis of this analysis, whether or not local delivery of antibiotics from the cement beads in these studies provided any substantial benefit. It is important to note that rather worrisome rates of loosening and inferior functional results have been reported after the insertion of femoral prostheses without cement for the treatment of infection at the site of a hip arthroplasty98,138. Insertion of the femoral component with cement combined with insertion of the acetabular component without cement has provided better functional results than have femoral and acetabular reconstructions done without cement138. Currently, most of the delayed reimplantations that we perform involve insertion of the acetabular component without cement and fixation of the femoral component with antibiotic-impregnated cement.

Bone-Grafting
The use of structural bone graft for reimplantation of a prosthesis in a patient who had had an infection at the site of a total hip arthroplasty was not associated with an increased risk of reinfection in several studies11,46,76,91,98,138; however, none of these studies involved the use of massive structural bone graft. Two reports on the use of massive structural allograft for reconstruction of large acetabular or femoral defects in a total of fifty-seven patients, with all components fixed with antibiotic-impregnated bone cement, did not reveal an increased risk of reinfection2,78.

An alternative method for the treatment of patients who have massive bone defects is a three-stage reconstruction98. The first stage consists of resection arthroplasty and subsequent therapy with antibiotics; the second stage, performed three to six months later, consists of bone-grafting with use of a 50-50 particulate mixture of cancellous autogenous graft and allograft; and the third stage, performed nine to twelve months after the bone-grafting, consists of insertion of a new prosthesis without cement. All of the patients in this small subset had a successful outcome98. This technique warrants consideration, particularly for the acetabulum, for patients who have extensive bone loss, as bone graft appears to incorporate more readily in this region than in the femur. The use of massive structural allografts for delayed reconstruction in patients who have an infection at the site of a total hip arthroplasty appears to be increasing.


   Footnotes
 
*Printed with permission of the American Academy of Orthopaedic Surgeons. This article will appear in Instructional Course Lectures, Volume 48, American Academy of Orthopaedic Surgeons, Rosemont, Illinois, March 1999.

{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}Department of Orthopedic Surgery, Mayo Clinic, 200 First Street S.W., Rochester, Minnesota 55905.

§Mayo Clinic Scottsdale, 13400 East Shea Boulevard, Scottsdale, Arizona 85259.


   References
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 Introduction
 Etiology
 Infection at the Site...
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