Periprosthetic joint infection (PJI) after total hip arthroplasty (THA) remains one of the most serious complications and a key challenge to orthopedic surgeons.1,2 The goals of treatment for PJI should be to minimize morbidity and mortality, maximize functional outcome, and eradicate the offending organism. Several treatment protocols have been reported and could be classified into irrigation and debridement with component retention,3 1-stage exchange,4 and 2-stage exchange protocol.5 Among these, the 2-stage exchange protocol is considered the most effective for eradication of chronic PJI and offers functional recovery of the hip joint in up to 90% of patients.6–8 The first stage consists of implant removal and thorough debridement, including cement, followed by a period of intravenous antibiotic therapy. After eradication of infection, delayed reimplantation of a new prosthesis is performed at the second stage.9 Recently, articulating prosthetic or cement spacers are commonly used for the purposes of effective local antibiotic delivery, maintenance of limb length, continued mobilization, and facilitation of reimplantation.2,5,10,11 Although these temporary spacers are usually supposed to be removed during the second-stage reimplantation, in practice not all patients can complete the second-stage reimplantation for various reasons and retain their spacers for a longer period than expected.12,13 However, the outcomes of unintended retention of temporary spacers have been sporadically reported, and the data on PJI after THA and total knee arthroplasty (TKA) have often been combined.2,12–15
The aim of this study was to investigate the clinical and radiographic outcomes of unintended retention of temporary articulating spacers in patients who underwent the first-stage operation of a planned 2-stage exchange protocol for the treatment of PJI after THA.
Materials and Methods
Between January 2007 and December 2014, 94 patients (95 hips) with PJI after THA were treated by a 2-stage exchange protocol using temporary articulating prosthetic spacers with antibiotic-loaded cement. Among the 94 patients, 46 patients (47 hips) completed the planned second-stage reimplantation, 8 patients (8 hips) died of reasons unrelated to surgery, and 5 patients (5 hips) were lost to follow-up within 12 months. The remaining 35 patients (35 hips) did not complete second-stage reimplantation and retained their temporary articulating spacers for more than 12 months. After obtaining institutional review board approval, the authors retrospectively analyzed the outcomes of these 35 patients.
There were 19 males and 16 females with a mean body mass index (BMI) of 22.6 kg/m2 (range, 14.5–32.1 kg/m2). Mean age at the time of first-stage operation for PJI of the hip was 64.5 years (range, 39–85 years). The mean follow-up period was 36.1 months (range, 12–89 months). The underlying diagnoses for primary THA were femoral neck fractures (n=13), trochanteric fractures (n=7), osteonecrosis of the femoral head (n=10), primary osteoarthritis (n=2), and secondary osteoarthritis (n=3). Primary THA was performed at the authors' institution in 14 patients and at another hospital in 21 patients. Infection occurred after primary THA in 16 patients, bipolar hemiarthroplasty in 12 patients, and revision THA in 7 patients. They underwent a mean of 1.8 operations (range, 1–4 operations) on the same hip. The mean interval from previous surgery to first-stage operation was 22.8 months (range, 1–86 months). Thirty patients had more than 1 medical problem, and 10 patients had diabetes mellitus at the time of first-stage operation. Patients were categorized according to the American Society of Anesthesiologists (ASA) classification16 to characterize their physical status: 9 cases of ASA I (normal healthy patients), 17 cases of ASA II (patients with mild systemic disease), and 9 cases of ASA III (patients with severe systemic disease that is not incapacitating).
The diagnosis of PJI was made according to the Workgroup of the Musculoskeletal Infection Society17 and classified as early postoperative (n=7), acute hematogenous (n=3), and chronic infections (n=25) based on the criteria of Tsukayama et al.18 Preoperative aspiration or intraoperative culture from periprosthetic soft tissue was performed to identify infecting organisms. Methicillin-resistant coagulase-negative Staphylococcus was the most common causative organism (n=11), followed by methicillin-resistant S aureus (n=6). There were 8 joints with negative culture results and 1 polybacterial infection (Table 1). During surgery, the authors tried to remove all of the possible implants and all foreign materials, including cement, devitalized bone, and soft tissue; however, they could not remove well-fixed cementless femoral stems in 18 patients. No extended trochanteric osteotomy was performed during the first-stage operation. After meticulous debridement and massive irrigation, temporary articulating spacers consisting of a new or resterilized prosthetic femoral stem (n=17) and an all-polyethylene acetabular cup (n=35) were inserted with antibiotic-loaded bone cement (2.0 g of vancomycin per 40 g of cement). All spacers were coated with doughy antibiotic-loaded cement before implantation and then inserted manually without extreme pressure to avoid excessive interdigitation of the cement into the cancellous bone (Figure 1).
Infecting Organisms at First-Stage Operation
Antibiotic-loaded bone cement was mixed manually (A). All spacers were coated with doughy antibiotic-loaded cement before implantation and were inserted manually without extreme pressure (B).
The postoperative protocol was similar to that for conventional primary THA (early mobilization with tolerable weight bearing), and a 6-week period of organism-sensitive intravenous antibiotic therapy was applied in all patients. When the culture result was negative, empirical broad-spectrum antibiotic was given in consultation with an infectious disease specialist. The major reasons for not completing second-stage reimplantation included no desire for reimplantation due to satisfactory joint function without pain (n=25), inadequate patient conditions for surgery (n=6), and economic problems (n=4). Treatment success was defined according to the modified Delphi international multidisciplinary consensus definition19: (1) infection eradication, characterized by a healed wound without fistula, drainage, or pain and no infection recurrence caused by the same organism strain; and (2) no further surgical intervention for any reason after articulating spacer implantation.
The clinical evaluation included a physical examination, Harris Hip Score,20 and walking ability estimated according to Koval et al.21 Standard radiographs included an anteroposterior view of the pelvis and anteroposterior and lateral views of the proximal part of the femur. Radiographs obtained 4 weeks after the index operation served as the baseline for all subsequent comparisons. The authors described radiographic evaluations of the acetabular component using DeLee and Charnley22 zones and those of the femur using the system of Gruen et al.23 Components were considered radiographically loose when migration had occurred or progression of circumferential radiolucency of 2 mm or greater was noted at the cement-bone interface. Evidence of migration was measured on serial radiographs and defined when a linear change of greater than 5 mm or a rotational change of 5° or greater of the component was noted.24,25 In addition, the authors compared patient characteristics, classification of infection, presence of methicillin-resistant organisms, and surgical procedure (whether the previous femoral stem was retained) between the success and failure groups.
Statistical analysis was performed with SPSS software version 20.0 (IBM, Armonk, New York). Chi-square test and Fisher's exact test were used to compare categorical variables, and the Mann–Whitney U test was used to compare continuous variables between the 2 groups. Significance was set at P<.05.
Thirty-one (88.6%) of 35 patients had well-healed wounds without recurrent infection and did not receive further surgical intervention for any reason at the latest follow-up (Figures 2–3). Harris Hip Score of the success group improved from 45.2 points (range, 28–63 points) preoperatively to 86.5 points (range, 43–94 points) at the final follow-up. The mean walking ability was also improved from grade 3.5 (range, 1–6) preoperatively to grade 2.8 (range, 1–6) at the latest follow-up. Twenty-six (83.9%) patients could return to or were improved from their preoperative walking ability. There was 1 case of dislocation, which was treated with closed reduction 7 weeks after surgery. Although there was also 1 case of radiographic loosening of the acetabular component 27 months after surgery, the patient refused further surgery because of satisfactory joint function without recurrent infection.
Anteroposterior radiographs of a 65-year-old woman. She presented with an infected bipolar hemiarthroplasty (A). An articulating spacer with an all-polyethylene cup was inserted. The femoral stem was also revised during surgery (B). At 13 months of follow-up, the temporary articulating spacer was well maintained and infection was eradicated. She was able to walk with an assistive device (C).
Anteroposterior radiographs of a 40-year-old woman. She presented with an infected total hip arthroplasty (A). An articulating spacer with an all-polyethylene cup and new prosthetic femoral stem was inserted during the first-stage operation (B). At 77 months of follow-up, the temporary articulating spacer was well maintained and infection was eradicated. She was able to walk without any assistive device (C).
The temporary articulating spacers failed in 4 (11.4%) patients (Figure 4). Harris Hip Score of the failure group was 42.4 points (range, 23–54 points) preoperatively and 59.0 points (range, 23–78 points) at the time of failure. The mean walking ability was worsened from grade 3.8 (range, 2–6) preoperatively to grade 4.6 (range, 2–6) at the time of failure. There were 2 cases of radiographic loosening of the acetabular component. One patient had an acetabular component migration with recurrent infection by the same organism (methicillin-resistant S aureus) 15 months after spacer insertion. He was treated by reimplantation of the articulating spacer with meticulous debridement. At the latest follow-up (8 months after reimplantation of articulating spacer), the patient showed no evidence of recurrent infection or radiographic loosening. The second patient had radiographic loosening of the acetabular component 37 months after spacer insertion. Although her wound was well healed and there was no sinus tract or fistula, laboratory findings were compatible with the definition of PJI. She was also treated by reimplantation of the articulation spacer with meticulous debridement. After 10 months of follow-up, this patient showed no evidence of recurrent infection or radiographic loosening and he could return to preoperative walking ability. The other 2 patients had purulent discharge from their wounds at 1 and 5 months, respectively, after articulating spacer insertion. These patients were treated by incision and debridement and showed well-functioning articulating spacers after 13 and 20 months of follow-up.
Anteroposterior radiographs of a 50-year-old woman. She was transferred to the authors' hospital with a septic loosening of the acetabular component (A). An articulating spacer with an all-polyethylene cup and new prosthetic femoral stem was inserted during the first-stage operation (B). Loosening of the acetabular cup was observed at 40 months after spacer insertion. The laboratory finding was compatible with the definition of periprosthetic infection (C). Re-revision was done with a new articulating spacer. Multiple screws were used due to the acetabular bone defect (D).
There were no statistically significant differences between the 2 groups in terms of age, sex, BMI, follow-up interval, ASA classification, presence of diabetes mellitus, or presence of resistant organism (Table 2). However, the success group underwent a mean of 1.6 operations (range, 1–4 operations) before articulating spacer insertion, and the failure group underwent a mean of 2.8 operations (range, 2–4 operations) before the index surgery (P=.04). There were 5 patients with early postoperative infection, 23 with chronic infection, and 3 with acute hematogenous infection in the success group and 2 patients with early postoperative and 2 patients with chronic infection in the failure group (P=.26). Although there were 14 patients whose cementless femoral stems were retained during the first-stage operation in the success group and 4 such patients in the failure group, the difference was not significant (P=.11).
Comparison of Demographics Between Success and Failure Groups
Although improvements in preoperative assessment, operating room discipline, surgical technique, and prophylactic use of antibiotics have reduced the incidence of PJI after THA,1,2 treatment of PJI remains a challenge. Among several treatment options for PJI of the hip, most studies have reported that the 2-stage exchange protocol has a more than 80% success rate.2,5,10,26–28 During the interim periods of this protocol, articulating prosthetic or cement spacers are commonly used. Theoretically, these temporary spacers are expected to be removed and replaced with new implants during the second-stage reimplantation; however, in practice, the reimplantation rate varies from 28.6% to 100%,26,29,30 and a considerable number of patients do not complete the second-stage reimplantation and retain their spacers for longer than expected.12,13 In the current study, 35 (36.8%) of 95 hips that underwent the first stage of the 2-stage exchange protocol did not undergo subsequent reimplantation surgery. This is a relatively high rate of spacer retention in comparison with that in most studies.27,31–33 Choi et al33 reported that the medical conditions of elderly patients are not always suitable for repeated extensive surgery and many patients are not eager to undergo second-stage reimplantation for the treatment of infection. In the current study, 19 (54.3%) of 35 patients were older than 65 years, and 25 (71.4%) patients did not want to undergo the second-stage reimplantation surgery because they were satisfied with their current level of function with the articulating spacer in situ. Furthermore, Gomez et al12 followed 504 cases of PJI (326 knees and 178 hips) for a mean of 56 months and reported that the type of the infecting organism and comorbid medical conditions might influence the likelihood of a patient completing both stages. The current authors also had 19 (54.3%) patients with PJI caused by methicillin-resistant organisms and 26 (74.3%) patients with ASA II or III. The results suggested that surgeons should be conscious of these factors before choosing the treatment options for PJI of the hip.
When surgeons decide whether retention of articulating spacers is an alternative treatment, several factors, such as patients' functional recovery, longevity of retained spacers, and eradication of infection, might be considered. Durbhakula et al2 described 2 patients who retained their spacers as the definitive treatment for PJI after 41 and 67 months of follow-up, respectively. Both patients ambulated with an assistive device and minimal discomfort. In another study13 of 18 retained spacers for infected THA or TKA, it was reported that 15 patients had well-functioning articulating spacers and 11 patients were able to ambulate without pain. In the current study, the Harris Hip Score improved from a mean of 45 points to 86 points, and 30 patients could return to or be improved from their preoperative walking ability. There is some controversy regarding the longevity of retained spacers. Regis et al14 reported 1 case of 6 years of follow-up of retained antibiotic-loaded cement spacer and suggested that prolonged spacer implantation was not appropriate as a permanent solution due to remarkable radiologic changes (at 6 years) and a fatigue fracture of the stem of the spacer (at 2 years). Recently, Choi et al13 reported a case of mechanical loosening of the femoral component of the spacer at 74 months after spacer insertion and suggested that temporary prosthetic spacers can be expected to survive up to 6 years. In the current study, the mean follow-up period in the success group was 36.5 months (range, 12–89 months) and there was no mechanical loosening at the latest follow-up. These results suggest that retained articulating spacers can survive a short- to mid-term follow-up period and might be beneficial for selected patients who need to avoid the risk of major surgery.
Another concern about the retention of temporary spacers is eradication of infection. Recently, Gomez et al12 reported that of 39 patients with hip PJI who did not undergo second-stage reimplantation, 5 (12.8%) patients needed further surgical intervention, such as a Girdlestone procedure. However, other investigators reported that 5 patients who retained their temporary spacers demonstrated a 100% rate of infection control after a mean follow-up of 82 months (range, 38.8–143.4 months).26 In the current study, 4 (11.4%) patients needed further surgical intervention to control recurrent infection. Another important aspect of the current study is that the resistance of the infecting organism or retention of a well-fixed cementless femoral stem during spacer insertion did not significantly affect the results. This finding is similar to those of most other studies that used the 2-stage exchange protocol.2,5,10,26–28
Limitations of the current study included its retrospective design, which may have introduced bias; a relatively short follow-up period, which was not sufficient to estimate longevity of the spacer; a small number of patients, which made it difficult to determine prognostic or risk factors; various cementing techniques of the spacers, which depends on the surgeons' preference and may affect mechanical strength; and the fact that 18 well-fixed cementless femoral stems were not removed during surgery, which were not really temporary spacers and may affect the results. However, this was a consecutive series of PJI patients who were treated at the same institution using a consistent protocol, and the authors could follow the patients for up to 7 years despite their relatively old age. Although some of the spacers had an optimal cement-bone interface on postoperative radiographs, all spacers were coated with antibiotic-loaded cement before implantation and inserted without pressurization.
Although the retention of a temporary spacer may not be the standard technique for the treatment of PJI, 89% of the current patients who retained their articulating spacers functioned well after a mean follow-up of 3 years (up to 7 years). These results support the idea that retention of articulating prosthetic spacers could be considered an alternative treatment option for select patients who need to avoid the risk of major surgery. A further prospective randomized study would be required to determine the candidate for this technique and ascertain the factors that can affect the results.
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- Durbhakula SM, Czajka J, Fuchs MD, Uhl RL. Spacer endoprosthesis for the treatment of infected total hip arthroplasty. J Arthroplasty. 2004;19(6):760–767. doi:10.1016/j.arth.2004.02.037 [CrossRef] PMID:15343538
- Bryan AJ, Abdel MP, Sanders TL, Fitzgerald SF, Hanssen AD, Berry DJ. Irrigation and debridement with component retention for acute infection after hip arthroplasty: improved results with contemporary management. J Bone Joint Surg Am. 2017;99(23):2011–2018. doi:10.2106/JBJS.16.01103 [CrossRef] PMID:29206791
- Ilchmann T, Zimmerli W, Ochsner PE, et al. One-stage revision of infected hip arthroplasty: outcome of 39 consecutive hips. Int Orthop. 2016;40(5):913–918. doi:10.1007/s00264-015-2833-4 [CrossRef] PMID:26224611
- Biring GS, Kostamo T, Garbuz DS, Masri BA, Duncan CP. Two-stage revision arthroplasty of the hip for infection using an interim articulated Prostalac hip spacer: a 10- to 15-year follow-up study. J Bone Joint Surg Br. 2009;91(11):1431–1437. doi:10.1302/0301-620X.91B11.22026 [CrossRef] PMID:19880885
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- Lieberman JR, Callaway GH, Salvati EA, Pellicci PM, Brause BD. Treatment of the infected total hip arthroplasty with a two-stage reimplantation protocol. Clin Orthop Relat Res. 1994;(301):205–212. doi:10.1097/00003086-199404000-00032 [CrossRef] PMID:8156676
- Cui Q, Mihalko WM, Shields JS, Ries M, Saleh KJ. Antibiotic-impregnated cement spacers for the treatment of infection associated with total hip or knee arthroplasty. J Bone Joint Surg Am. 2007;89(4):871–882. doi:10.2106/JBJS.E.01070 [CrossRef] PMID:17403814
- Etienne G, Waldman B, Rajadhyaksha AD, Ragland PS, Mont MA. Use of a functional temporary prosthesis in a two-stage approach to infection at the site of a total hip arthroplasty. J Bone Joint Surg Am. 2003;85-A(suppl 4):94–96. doi:10.2106/00004623-200300004-00011 [CrossRef] PMID:14652398
- Pattyn C, De Geest T, Ackerman P, Audenaert E. Preformed gentamicin spacers in two-stage revision hip arthroplasty: functional results and complications. Int Orthop. 2011;35(10):1471–1476. doi:10.1007/s00264-010-1172-8 [CrossRef] PMID:21116817
- Gomez MM, Tan TL, Manrique J, Deirmengian GK, Parvizi J. The fate of spacers in the treatment of periprosthetic joint infection. J Bone Joint Surg Am. 2015;97(18):1495–1502. doi:10.2106/JBJS.N.00958 [CrossRef] PMID:26378265
- Choi HR, Freiberg AA, Malchau H, Rubash HE, Kwon YM. The fate of unplanned retention of prosthetic articulating spacers for infected total hip and total knee arthroplasty. J Arthroplasty. 2014;29(4):690–693. doi:10.1016/j.arth.2013.07.013 [CrossRef] PMID:23932758
- Regis D, Sandri A, Magnan B, Bartolozzi P. Six-year follow-up of a preformed spacer for the management of chronically infected total hip arthroplasty. Arch Orthop Trauma Surg. 2010;130(9):1111–1115. doi:10.1007/s00402-009-0984-8 [CrossRef] PMID:19841926
- Jämsen E, Sheng P, Halonen P, et al. Spacer prostheses in two-stage revision of infected knee arthroplasty. Int Orthop. 2006;30(4):257–261. doi:10.1007/s00264-006-0102-2 [CrossRef] PMID:16565839
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Infecting Organisms at First-Stage Operation
|Success Group (n=31)||Failure Group (n=4)||Total|
|Gram-positive Staphylococcus aureus|
Comparison of Demographics Between Success and Failure Groups
|Variable||Success Group (n=31)||Failure Group (n=4)||P|
|Age, mean (range), y||64.3 (39–89)||66.8 (49–81)||.71|
|Sex, male:female, No.||16:15||3:1||.61|
|Body mass index, mean (range), kg/m2||22.5 (14.5–32)||22.8 (17.8–26.7)||.89|
|Follow-up, mean (range), mo||36.5 (12–89)||33 (12–57)||.86|
|Previous operations, mean (range), No.||1.6 (1–4)||2.8 (2–4)||.04|
|American Society of Anesthesiologists classification patients in grade I:grade II: grade III, No.||9:14:8||0:3:1||.40|
|Diabetes mellitus, No.||7 (22.6%)||3 (75%)||.06|
|Resistant organism, methicillin sensitive:methicillin resistant, No.||15:16||1:3||.61|