RECONSTRUCTION 2023, Jan, 16 | 12:00 am

Two Stage Revision for Infected Total Hip Replacement

Introduction                       

Deep infection (Fig. 40.1) following total hip replacement is a challenging complication for both the patient and the surgeon. The reported risk of infection following arthroplasty varies from 0.3%, reported by the British Medical Research Council1 to 2.2% in a large review by Sculco.2 Although the percentages appear small, given that the number of hip replacements is increasing, it relates to a large number of patients with periprosthetic infections who utilize a substantial amount of health-care resources and the Swedish Hip Registry reports that 7.3% of revisions are carried out for infection.3

In a study of 112 prosthetic joint infections, the most frequently isolated organisms were coagulase negative staphylococci (47% patients) and methicillin-sensitive Staphylococcus aureus (MSSA, 44% patients). 8% grew methicillin-resistant Staphylococcus aureus (MRSA) and 7% grew anaerobes.4 Another study found that 43% of positive tissue cultures were coagulase negative staphylococci of which approximately 50% were methicillin resistant suggesting that screening for methicillin resistant Staphylococcus epidermidis in addition to MRSA may become necessary.5

Fitzgerald et al6 classified prosthetic joint infections into Stage-I infections (Acute

fulminating infections) usually within six weeks, Stage-II infections (Delayed sepsis—chronic indolent infection) and Stage-III infections (Late hematogenous infections in a previously

 

 

 

 

Figure 40.1: Shows erythema and profuse discharge from wound

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well functioning hip replacement). Tsukayama et al7 proposed a fourth type where a positive culture is found at the time of revision surgery, without previous evidence of infection.

Total Hip Arthroplasty

 

Treatment options for an infected total hip replacement include chronic antibiotic suppression or excision arthroplasty for the very infirm or complex, debridement and replacement of exchangeable modular parts for the acutely infected hip, or revision by either a one stage [direct exchange] or two stage procedure. Both of these procedures require removal of the implant, radical debridement, and long-term antibiotic treatment. Eradication of the infection is difficult because of the high resistance of the bacteria to antibiotics, devascularised bone, poor penetration of antibiotics into infected bone,8,9 and in the case of direct exchange the adherence of bacteria to foreign bodies within biofilms.10,11

 

Indications                        

Surgery in the form of a one or two stage revision followed by antibiotic therapy is the mainstay of treatment for the infected arthroplasty. The precise indications for one-stage and two-stage revisions have not been completely delineated. However, there are certain indications where a two stage procedure is preferred. These include; poor bone stock where bone grafting is necessary for reconstruction, unknown, polymicrobial or resistant infection, recurrent infection, insufficient soft tissue coverage, presence of sinuses and when cementless implants are to be used.

Central to both approaches is local administration of high-dose antibiotics through a biocompatible medium such as polymethylmethacrylate cement. Addition of antibiotics to bone cement reduces its mechanical properties but higher antibiotic levels can be achieved at the site of the infection, when compared to parenteral antibiotics.12

One-stage revision of an infected THR is attractive not only for the patient but has economic advantages and a reported success rate ranging from 77 to 100%.13-15 Factors associated with a successful direct exchange included: (1) absence of wound complications after the initial total hip replacement; (2) good general health of the patient; (3) favorable pathogens such as methicillin-sensitive Staphylococcus epidermidis, Staphylococcus aureus, and Streptococcus species; and (4) an organism that was sensitive to the antibiotic mixed into the bone cement. Factors associated with failure included: (1) polymicrobial infection;

(2) gram-negative organisms, especially Pseudomonas species; and (3) certain gram-positive organisms such as methicillin-resistant Staphylococcus epidermidis and Group D Streptococcus.16

Two stage revision requires a radical debridement, removal of the implant with the use of a spacer, preferably articulated. An antibiotic-impregnated cement spacer can maintain soft tissue tension, leg length and provide better function than a resection arthroplasty, but there is a significant risk of dislocation or fracture of the spacer. Most authors use 6 weeks of antibiotics as standard and longer courses have not been found to be beneficial between the 2 stages of surgery. Guidance should however be given by a local microbiologist with a specialist interest in infected arthroplasties.

 

Preoperative                   Planning                   

The diagnosis of an infected total hip replacement can be difficult especially in an immuno-compromised host. A thorough history and examination is vital in the investigation of a painful total joint replacement. The main symptoms of an infected arthroplasty are pain and persisting wound discharge. Approximately 40% of infected arthroplasty cases are obvious in the first two weeks after the surgery and will demonstrate a persisting discharge from the wound.17 A more delayed diagnosis is made in a further 40% of cases (i.e. after the wound has healed). Here a history of superficial wound infection in the postoperative period, prolonged antibiotic administration or persistent pain should be sought. In addition, one

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should ask about patient-related predisposing factors to infection such as diabetes, rheumatoid arthritis, oral steroids and other causes of immune compromise.18

Two Stage Revision for Infected Total Hip Replacement

 

A combination of clinical evaluation, blood investigations, imaging and microbiological assessment improves diagnostic ability. The white blood cell count is seldom raised in infected arthroplasty and therefore not a useful test. However both ESR and CRP are useful tests, particularly when multiple samples are used to reflect a trend.19-22 The downside of the ESR—erythrocyte sedimentation rate is that it can remain elevated for up to 1 year after an uncomplicated THR. CRP is more useful as it returns to normal approx 2-3 weeks post-op.19 If either the CRP or ESR is raised, a hip aspiration has a high sensitivity and specificity and is recommended.23-25 The aim is to discover the responsible organisms together with their antibiotic sensitivities, which will greatly aid treatment. There is consensus that antibiotics should be stopped for two weeks before the test. Liaising with an interested local consultant microbiologist about the case will help in identifying common local strains of organisms and their sensitivity. Sometimes an extended culture is helpful in identifying organisms with a low virulence. The leucocyte count of the aspirate has also been studied but has sensitivities ranging from 36 to 89% depending on the leucocyte count threshold

used.

Nuclear imaging results vary in the literature from as low as 38% sensitivity23 to 86% sensitivity 24of a leucocyte labelled scan. An area of research interest is the use of fluoro-deoxyglucose-positron emission tomography (FDP-PET) scans. However at present their results in infected arthroplasty are no better than standard Technetium scans.25

The features of sepsis on plain radiographs are sometimes present in chronic cases. They include; Periostitis, lucent lines and rapidly progressive osteolysis and periosteal new bone formation.

Knowing the specifics of the primary implant is important. Having appropriate implant specific removal devices are better than generic devices, for example, liner disengagement devices may vary dependent on the manufacturer. For cemented components we use the Moreland acetabular and femoral instruments that contain an array of long chisels and component extraction devices. For uncemented acetabular cups we use the Explant device and with this we have found that very little host bone is sacrificed. Removal of the uncemented stem which may be well fixed in spite of infection can be difficult. The implant manufacturer may have a specific technique or instrument to facilitate removal, and having long flexible osteotomes and an ultrasonic device such as Oscar for cement removal is essential.

 

Implant                     Features                     

For 2-stage revisions, we feel that the use of a spacer is an essential requirement. The benefit of a spacer is to maintain soft tissue length and to act as a medium for delivery of antibiotics. There are essentially two kinds of spacers: articulating spacers or void fillers such as cement beads or monoblocks (Figs 40.2 and 40.3).

We prefer to use an articulating cement spacer as it not only maintains soft tissue length but also provides hip stability and allows movement. Examples include; prosthesis of antibiotic-loaded acrylic cement (PROSTALAC; DePuy, Warsaw, Indiana) which is a temporary hip-replacement articulated spacer or a cement mould such as StageOne™ Hip Cement Spacer (Biomet, Warsaw, Indiana).26 Alternatively, a prefabricated spacer such as the Spacer G (Tecres S. PA, Sommacompagna, Verona, Italy)27 can be used (Figs 40.4 and 40.5).

Étienne et al,28 have shown good results by autoclaving the removed femoral component, coating it with a layer of cement and mating this with a cemented polyethylene acetabular liner. Additional antibiotics can be added to the cement as indicated by the culture results from the preoperative aspiration. This is possible in the PROSTALAC or StageOne spacer but not in the prefabricated spacers. The ideal antibiotic should be broad spectrum, bactericidal and have low resistance rate, high water solubility, thermal and chemical stability (Fig. 40.6).

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Total Hip Arthroplasty

 

Figures 40.2A to D: Hand made spacer using rush nail

 

Figure 40.3: Hand made spacer reinforced with K-wires

 

 

 

 

Figures 40.4A to D: Cement mold

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Figure 40.6: Autoclaved antibiotic cement coated implant used as spacer

Figure 40.5: Prostalac spacer

 

Two Stage Revision for Infected Total Hip Replacement

 

The choice of antibiotic is best made in advance by knowing the infective organism and culture results from a hip aspirate. If this is not available then discussion with the microbiologist regarding commonly found local strains of organisms can influence the choice of antibiotics. If the hip aspiration was negative, but other indices of infection were positive, we routinely added gentamicin and vancomycin since this would cover the sensitivity profile of most bacteria encountered in prosthetic joint infection. With vancomycin, we added 2 g of powder to each 40 g mix of cement.

The total amount of antibiotic that can be added to the cement varies considerably. There is no recommended amount but a heat stable, water-soluble antibiotic needs to be used with concentrations of up to 10% of the volume of cement. The antibiotic powder should be added to the cement powder in a fractionated manner, and when making a spacer hand mixing is preferred to vacuum to produce a more porous cement. The addition of any antibiotic will however have a detrimental effect upon the mechanical strength of the resulting cement.29

High doses of antibiotic in the cement have been shown not to cause systemic toxicity.30 Antibiotic release from PMMA is biphasic as demonstrated in in vivo and in vitro studies.31-37 The high release in the first 24 hours is then replaced by a prolonged elution at low concentrations. The elution rate of antibiotics from cement is variable and depends upon the porosity of cement and combinations of antibiotics used. Increased porosity of the cement allows more access for the extracellular fluid to contained antibiotic via channels and pores. Masri et al32 demonstrated in an in vivo experiment in humans that the elution of

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Total Hip Arthroplasty

 

vancomycin is improved with the addition of tobramycin in cement. They also found that at four months the spacer prosthesis was still eluting antibiotic concentrations above the minimum inhibitory concentration. One can add hydrophilic compounds to the PMMA in order to significantly boost antibiotic release, e.g. calcium carbonate in Copal Spacem® cement [Heraeus Medical] which is designed for joint spacers. When comparing beads and spacers as antibiotic delivery systems, similar efficacy in eradication of infection was seen,33 but the additional advantages of spacers have been discussed above.

 

Surgery

 

APPROACH/EXPOSURE

The choice and extent of the surgical approach in 2 stage revision or any other revision arthroplasty depends upon previous surgical approach, experience of the surgeon and presence of acetabular or femoral bone loss. An ideal approach should provide satisfactory exposure of both components, protect neurovascular structures, minimize bone and soft tissue devitalization and allow for extension in case of complications.

The use of prior incisions is recommended when possible to avoid railroad-track scars and potential risk of intervening skin necrosis. Laterally placed skin incisions can migrate with time and one could include the old scar in the new incision if skin laxity permits the correct facial incision underneath.

We prefer to use a posterior approach in all cases and position the patient on their side with appropriate supports. The advantages of a posterior approach are good circumferential exposure of the acetabulum without disturbance of the abductor mechanism, posterior column visualization, a lower rate of heterotrophic ossification and its extensile nature.38-40 Also in cases where an anterior or direct lateral approach has been used previously the posterior approach is easier to perform by going through virgin unscarred territory. A further advantage is the ease with which it can be extended distally by using the extended trochanteric osteotomy (Fig. 40.7).

The extended trochanteric osteotomy41,42 is an extremely useful technique when removing solidly fixed cemented and cementless stems even in a setting of infection. A posterior approach to the hip is extended distally along the posterolateral aspect of the femoral shaft. The vastus lateralis is elevated subperiosteally leaving a small cuff at its insertion to the linea aspera to prevent retraction of perforators beyond the intermuscular septum. Proximal

 

 

 

Figure 40.7: Stem removal using extended trochanteric osteotomy

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migration or displacement of the osteotomy is prevented by maintaining the attachment of vastus lateralis distally as a tether.

 

PROCEDURE

Two Stage Revision for Infected Total Hip Replacement

 

The sciatic nerve is identified by direct exposure and marked with a nerve tape to establish its location and highlight it through the procedure. An extensive debridement of potentially infected or contaminated periarticular soft tissue performed. A radical debridement is paramount to the success of eradicating infection since all foreign material and abnormal tissue must be removed. A complete capsulectomy is necessary and osseous debridement must also be radical. No compromise should be made to simplify a subsequent reconstruction. Multiple samples are obtained for microbiology before antibiotics are administered. Altogether a minimum 5 samples, each taken with fresh instruments, is recommended; a swab of joint fluid, capsular tissue, acetabular membrane, femoral membrane and any other abnormal tissue (e.g. granulation tissue). A few specimens are sent for histology. Atkins et al43 have demonstrated that the isolation of indistinguishable microorganisms from three or more independent operative specimens is highly predictive of the presence of acute inflammatory cells in specimens examined histologically which confirms infection. They also recommend that the culture of five or six specimens obtained during surgery is necessary to produce a diagnostic test that is both sensitive and specific. Extended cultures of 14 days are required to detect some organisms.

The success of the second stage revision to a great extent relies upon the quality of host bone remaining following implant removal. In chronic infection, the implants may be loose and easily removed. However, the removal of well fixed implants can be very technically demanding with potential for producing bone loss and fracture during the procedure. The goal is to minimize bone loss through careful preoperative planning and to ensure any specialized removal equipment that may be required is available.

The preoperative plan for removal should include good AP and lateral radiographs and if necessary Judet views for the acetabulum are obtained. It is essential to know the implant manufacturer, size of implants, type of locking mechanism for the liner, and the type of screw heads if used from implant record labels in the case notes. If necessary the details should be obtained from the original surgeon or institution where the previous operation was performed.

 

REMOVAL OF CEMENTED CUPS

Cemented cups are removed following a good exposure of the periphery of the cup to delineate the polyethelene, cement and bone interfaces. Curved specialized osteotomes are used to develop the cup-cement interface to avoid damage to underlying bone stock. Once adequately mobilized all around the circumference the cup can be levered out of the cement mantle gently or a threaded extractor may be inserted into the polyethylene through a drill hole to allow disimpaction and removal of the cup. The cement is then carefully divided using a range of curved narrow osteotomes and removed piecemeal, following which the key holes are cleared.

 

REMOVAL OF UNCEMENTED CUPS

The liner in an uncemented cup is removed first to allow access to any screws which may have been used. Many acetabular liners have locking mechanisms that may require specialized tools or techniques for removal. In other cases it may be possible to use a small lever behind the rim to pry the liner out of place. If a polyliner is used then a screw advanced through it will disengage the liner as the screw tip touches the metal shell. A tip is to use a size larger trial shell screwed onto a handle in reverse and use it to impact on the edge of the metal shell avoiding the ceramic liner thus disimpacting the morse taper and allowing removal of the liner.

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Total Hip Arthroplasty

 

Removal of an uncemented shell can be done using either the Explant system (Explant Acetabular Removal System; Zimmer, Warsaw, IN) or curved osteotomes as described above. The Explant system uses a curved blade specific to the diameter of the shell attached to a rotating handle device that is centered in the liner by a head component of appropriate size. First a short blade is used to open up the interface between host bone and shell and then a full length curved blade completely releases the implant from bone.

 

REMOVAL OF CEMENTED STEM

The principle in removing cemented stems is to remove the stem first followed by the cement. Following an adequate exposure, the proximal and lateral aspect of the femur is cleared of cement and soft tissue using a combination of narrow gouges and osteotomes to allow extraction of the stem. In a curved stem, it is essential to clear the cement beyond the shoulder before attempting stem removal which reduces the risk of fracture. It is best to work from the cement-stem interface outwards in order to avoid unnecessary damage to adjacent bone. Once the implant has been extracted safely, any remaining cement must be removed by carefully splitting the cement and developing the interface between cement and bone. This is done using special long cement splitting chisels and gouges. In case of textured or precoated cement stems, one could remove the stem by either loosening the stem from the cement

using thin/flexible osteotomes from above or an extended trochanteric osteotomy.

Apart from manual techniques, the options include use of high-energy ultrasound delivered directly to the cement mantle; this heats and softens the polymethylmethacrylate (PMMA), with little damage to cortical bone.44,45 Our preferred technique involves using narrow gouges to remove the proximal cement followed by use of OSCAR to breach the distal cement plug and then the use of reverse cutting narrow long osteotomes to remove the remaining cement from below upwards.

 

REMOVAL OF UNCEMENTED STEMS

Removal of proximally coated cementless stems can be done using long thin flexible osteotomes from above and the extent of the coating must be known in advance. This can be difficult in some cases where the distal portion of the stem may have a rough surface with bone ongrowth. In such situations and in the case of fully coated stems, an extended trochanteric osteotomy is preferred.

After implant removal, the bony debridement includes reaming the acetabulum and femur, curettage of cavitary defects, and excision of sclerotic bone or thorough debridement with a high-speed bur. Thorough records of the bony defects are made which will help planning for the 2nd stage reconstruction.

Following debridement, the cavity can managed with antibiotic beads/blocks or an articulating spacer. Despite more than a 90% eradication of infection rate, controversy exists regarding which of the 2-stage techniques has the best clinical outcome. Traditionally, all implants are removed and antibiotic beads implanted to deliver antibiotics in high concentration. However, this technique leaves the patient with a shortened limb, higher energy requirements for gait, loss of tissue planes, and contracted soft tissues. Techniques using antibiotic-laden cement articulating spacers allow patients limited weight-bearing mobilization and thus have gained popularity. Reported advantages of the articulating spacers include maintenance of soft tissue length and tension, and making revision surgery technically easier. Furthermore, the infection eradication rates have been reported to be similar to other 2-stage techniques.

 

Postoperative                 Management                

After resection of all of the affected tissues and implantation of an antibiotic-impregnated cement spacer, patients typically receive a 6-week course of antibiotics, based on the

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sensitivities and in conjunction with the microbiologists. The second stage is performed 2 to 4 weeks after completion of antibiotic therapy and a further aspiration is performed. Outpatient monitoring included clinical examination and assessment of inflammatory markers such as erythrocyte sedimentation rate (ESR) and the level of C-reactive protein (CRP). When the soft tissues were quiescent and the serological markers were satisfactory (ESR < 20 mm/hr CRP < 10 mg/l), the patients were considered for a second-stage reconstruction. If there was evidence of persistent infection the first-stage procedure is repeated. During the second-stage revision, the cement spacer is removed and further multiple specimens are obtained to evaluate for persistent infection.

 

Complications                      

Apart from all the risks associated with any primary hip arthroplasty, revision surgery for any reason is fraught with a higher incidence of complications.

The risk of femoral perforation during cement, removal, canal preparation or the insertion of the prosthesis is very high especially in infections where there may be thin cortical bone additionally weakened by the disease and numerous revisions. Small femoral perforations are generally well tolerated and as long as the deficiency is bypassed by the stem by at least 2 cortical diameters, the risk of postoperative periprosthetic fractures is reduced. The risk of femoral and acetabular fractures is greatest during dislocation, removal of prosthesis, removal of cement and during implantation of the new component. Vascular injuries are rare but do occur more frequently during removal of a migrated intrapelvic acetabular component. Preoperative angiography is recommended in these cases. Apart from implant migration, scaring and abscesses can cause adhesions to vessels rendering them at risk. Scar tissue from previous surgical procedures can alter the anatomy and can risk femoral or sciatic nerve palsy during exposure. An awareness of potential pitfalls and careful preoperative planning is essential to reduce these risks and to counsel the patient appropriately.

 

Two Stage Revision for Infected Total Hip Replacement

 

Summary                        

A total of 7,136 hip revision procedures were reported in 2009 in the National Joint Registry,46 83% were single stage revision procedures and 13% were two stage revisions. 3% of all single stage revisions and 80% of all two stage revisions were carried out for infections.

Numerous studies of two stage hip revision have demonstrated over 90% efficacy in eradication of infection47-52 and as a result this treatment is considered to be the gold standard. The use of antibiotic-loaded cement at revision has been shown to reduce the rates of re-infection. Gentamicin-loaded cement was associated with eradication in 95% of patients at five years in one study.53 Hanssen and Rand54 had a cure rate of 82% without antibiotic cement at the second stage, compared with 90% when an antibiotic was used. A further aspiration of the hip prior to the second stage after a two week antibiotic holiday is mandatory and in one study there was a recurrence rate of 3% among those who underwent aspiration compared with 14% in those who did not.55

The main advantages over direct exchange are better control of infection, ability to observe response to treatment, ability to use bone graft or uncemented prosthesis at reimplantation. The main disadvantages are prolonged treatment and hospitalisation, inferior functional outcome in the interval and increased cost. The use of articulated spacers can however improve the situation.

There are controversies regarding the duration of antibiotic cover, length of interval between the 2 stages and whether to operate after normalization of inflammatory markers. Recent studies have indicated that prolonged administration of systemic antibiotics may not be essential to achieve a high rate of success in the eradication of gram-positive chronic periprosthetic hip infection.56,57 Stockley et al recommend the use of antibiotics only in the cement without the use of prolonged intravenous or oral antibiotic therapy between the two

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stages. They demonstrated an 87.7% success in eradication of infection in a series of 114 patients.58

Total Hip Arthroplasty

 

The essentials of two stage revision in our institution are a radical debridement, identification of the pathogen and its sensitivities, knowledge of the implant to be removed with the availability of specific equipment when necessary, close cooperation with a dedicated microbiologist, the use of articulated cement spacers, monitoring of the trends in the blood indices, re-aspiration after a two week antibiotic holiday and the willingness to repeat the first stage if necessary.

Illustrations courtesy of the Palacademy Panel of International Experts (Heraeus GmbH), particularly Mr P Partington, Mr M Reed and Dr M Villanueva.

 

References                       

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  3. Swedish National Arthroplasty Register, Annual Report 2006 – full report accessed at http:// www.jru.orthop.gu.se/

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  20. Spangehl MJ, Masri BA, Oconnell JX, Duncan CP. Prospective analysis of preoperative and intraoperative investigations for the diagnosis of infection at the sites of two hundred and two revision total hip arthroplasties. J Bone Joint Surg Am 1999;81(5):672-82.

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  23. Lachiewicz PF, Rogers GD, Thomason HC. Aspiration of the hip joint before revision total hip arthroplasty. Clinical and laboratory factors influencing attainment of a positive culture. J Bone Joint Surg Am 1996;78(5):749-54.

  24. *Spangehl MJ, Younger ASE, Masri BA, Duncan CP. Diagnosis of infection following total hip arthroplasty. J Bone Joint Surg Am 1997;79:1578-88.

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  34. Springer BD, Lee GC, Osmon D, et al. Systemic safety of high-dose antibiotic-loaded cement spacers after resection of an infected total knee arthroplasty. Clin Orthop 2004;427:47-51.

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  36. Masri BA, Duncan CP, Beauchamp CP. Long-term elution of antibiotics from bone-cement: an in vivo study using the prosthesis of antibiotic-loaded acrylic cement (PROSTALAC) system. J Arthroplasty 1998;13(3):331-8.

  37. Hsieh P, Shin C, Chang Y, Lee MS, Shin H, Yang W. Two stage revision hip arthroplasty for infection. J Bone Joint Surg Am 2004;86(9):1989-97.

  38. Hardinge K. The direct lateral approach to the hip. J Bone Joint Surg Br 1982;64:17-9.

  39. Ramesh M, O Byrne JM, McCarthy N, Jarvis A, Mahalingham K, Cashman WF. Damage to the superior gluteal nerve after the Hardinge approach to the hip. J Bone Joint Surg Br 1996;78:903-6.

  40. Horwitz BR, Rockowitz NL, Goll SR, et al. A prospective randomized comparison of two surgical approaches to total hip arthroplasty. Clin Orthop 1993;291:154-63.

  41. Younger TI, Bradford MS, Magnus RE, Paprosky WG. Extended proximal femoral osteotomy: A new technique for femoral revision arthroplasty. J Arthroplasty 1995;10:329-38.

  42. Andrew R Noble, Daniel B Branham, Mark C Willis, John R Owen, Benjamin W Cramer, Jennifer S Wayne, William A Jiranek. Mechanical Effects of the Extended Trochanteric Osteotomy. J Bone Joint Surg Am 2005;87:521-9.

  43. Atkins BL, Athanasou N, Deeks JJ, Crook DW, Simpson H, Peto TE, et al. Prospective evaluation of criteria for microbiological diagnosis of prosthetic-joint infection at revision arthroplasty. The OSIRIS Collaborative Study Group. J Clin Microbiol 1998;36(10):2932-9.

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  44. Brooks AT, Nelson CL, Stewart CL, Skinner RA, Siems ML: Effect of an ultrasonic device on temperatures generated in bone and on bone-cement structure. J Arthroplasty 1993;8:413-8.

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