Purpose: Efforts to decrease polyethylene wear have lead to advances in polyethylene and counter-face technology for total hip replacement. In particular, the use of highly cross-linked polyethylene (XLPE) and more recently, oxidized zirconium (Oxinium) heads, have demonstrated significant in-vitro improvements in THR wear. This study reports on the early clinical performance and wear (measured with RSA) of an randomized controlled trial (RCT) comparing Oxinium and CoCr heads on XLPE and conventional polyethylene (CPE).

Method: Forty patients were enrolled in a RCT and stratified to receive either an Oxinium (Ox) or CoCr head against either XLPE or CPE (ie 10 patients in each group). All patients had otherwise identical THRs and had tantalum beads inserted in the pelvis and polyethylene for wear analysis. There were no significant differences between groups with respect to patient demographics and the average age was 68 years (range 57–76) at index procedure. RSA wear analysis was performed immediately post-op, at six weeks, three and six months and then at one and two years. All patients are a minimum of four years post-op (average 4.6, range 4 – 5.8). Patients were followed prospectively using validated clinical outcome scores (WOMAC, SF-12, Harris Hip scores) and radiographs.

Results: All health-related outcomes were significantly improved from pre-operative with a mean Harris Hip score and WOMAC at last follow-up of 90.9 and 80.2, respectively. Total 3D femoral head penetration at two years for each group were the following: CoCrXLPE (0.068±0.029mm); OxXLPE (0.115±0.038mm); CoCrCPE (0.187±0.079mm); and OxCPE (0.242±0.088mm). Thus, OxCPE was significantly higher than OxXLPE and CoCrXLPE but not CoCrCPE (p=0.001, p> 0.0001 and p=0.094, respectively). In other words, head penetration was higher with CPE compared to XLPE but there was no significant difference between Ox and CoCr heads. Similarily, regardless of head type (ie combining similar poly types), there was a significant difference in 3D head penetration at two years between CPE and XLPE ( CPE 0.213±0.086; XLPE 0.093±0.041, p> 0.0001).

Conclusion: The early results of this RCT, using RSA as the wear analysis tool, indicate a significant improvement in wear with XLPE compared to CPE. However, it failed to show a clear advantage to the use of Oxinium over CoCr against either polyethylene. Longer follow-up is required to determine steady-state wear rates (after bedding-in) and allow comparison between bearing groups.

Purpose: The Genesis II total knee arthroplasty system was introduced in 1996 as the next evolution in TKR design characterized by “built-in” femoral external rotation and improved trochlear design to optimize patellar tracking and femoral/tibial kinematics, as well as a polished tibial base plate and ethylene-oxide sterilized polyethylene to minimize wear. The purpose of this prospective study was to evaluate the long-term (minimum 10 year) clinical and radiographic results and survivorship of this novel TKA implant system.

Method: Between 1996 and 1999, 478 Genesis II Primary TKRs were implanted and followed prospectively in 414 patients (mean follow-up 11.25±1.11 years). Diagnosis at index surgery included: 94% osteoarthritis, 5% inflammatory arthritis, 1% other diagnoses. Average age at index TKR was 68 years (range 38 to 93 years). There were 149 posterior cruciate retaining (31%) and 329 cruciate sacrificing (69%) knees implanted. Patella resurfacing was performed on 89% (432) of the cases. Sixty-seven deaths occurred prior to 10 years follow-up. Patients were followed prospectively using validated clinical outcome scores (WOMAC, SF-12, Knee Society scores) and radiographs. Kaplan-Meier survival analysis was performed.

Results: All health-related outcomes were significantly improved from preoperative with a mean Knee Society Score and WOMAC at last follow-up of 162 and 69, respectively. To date, 16 revision procedures have been performed. Revisions for infection included six two-stage revisions and two cases of irrigation & debridement with polyethylene exchange. In addition, there were three re-operations for stiffness and one for patellar instability. To date, there have been only two revisions for aseptic loosening and/or osteolysis. Excluding revisions for infection, the Kaplan-Meier survivorship analysis of the total knee system was 98.9±0.5% at five years and 98.2±0.6% at 10 years.

Conclusion: The Genesis II total knee arthroplasty system, characterized by “built-in” femoral external rotation, improved trochlear design, a polished tibial base plate and ethylene-oxide sterilized polyethylene, has demonstrated excellent clinical & radiographic results and long-term survivorship (98% at 10 years) at our institution.

Purpose: The range of motion after TKA depends on many patient, surgical technique, and implant factors. Recently, high-flexion designs have been introduced as a means of ensuring or gaining flexion after TKA. We therefore evaluated factors affecting postoperative flexion to determine whether implant design influences long-term flexion.

Method: We prospectively collected data on patients receiving a primary Genesis II total knee replacement with a minimum of 1-year followup (mean, 5.4 years; range, 1–13 years). We recorded pre – and postoperative outcome measures, patient demographics, and implant design (cruciate retaining [CR, n = 160], posterior stabilized [PS, n = 1177], high-flex posterior stabilized [HF-PS, n = 197]).

Results: Backward stepwise linear regression modeling revealed the following factors that significantly affected postoperative flexion: preoperative flexion, gender, body mass index, and implant design. Independent of gender, body mass index, and preoperative flexion, patients who received a HF-PS and PS design implant resulted in 8° and 5° more flexion, respectively, than those who received a CR implant. Based on analysis examining pre-operative flexion categories, patients with low flexion preoperatively (< 100°) were more likely to gain flexion, whereas those with high flexion preoperatively (> 120°) were most likely to maintain or lose flexion postoperatively. Controlling for implant design, patients with high flexion preoperatively (> 120°) were more likely to gain flexion with the HF-PS design implant (HF-PS = 32.0%; PS = 15.1%; CR = 4.5%).

Conclusion: In summary, our data demonstrate postoperative range of motion after TKA is related to several factors, confirming the important role of the patient’s preoperative range of motion. In addition, our review suggests knee design and, in particular, the use of a so called “high-flexion” PS polyethylene design may be advantageous in maintaining or improving flexion postoperatively, especially in those patients with good pre-operative range of motion.

Purpose: The purpose of this study was to determine the greater than 20 year survivorship of the PCA total hip arthroplasty (THA) in patients with severe hip osteoarthritis.

Method: A prospective follow-up of 315 consecutive patients treated with a PCA cementless THA in patients with hip osteoarthritis was performed. Patients had postoperative assessments and radiographs every two years. Overall THA, femoral stem and acetabular cup revisions and Kaplan-Meier survivorship was determined. Revision rates and survivorship was also investigated across gender.

Results: The mean age of our patients was 61 years old (range 20 to 86) with 47% female patients. 226 cases used a 26mm articulation and 89 cases a 32mm articulation. At 23 years follow-up, 188(60%) patients were alive with retained implants while 85(27%) were deceased with still implants that were functioning well. Forty-two cases (13%) were revised (30 sockets, 13 stems), five of which later deceased. The 20 year Kaplan Meier survivorship for the overall THA, stem component and acetabular cup were 86%, 97% and 90% respectively. Survivorship of the acetabular cup for 26mm and 32mm articulations was 92% and 85% respectively (p=0.016). Females had a worse THA survivorship than males, 82% and 91% respectively (p=0.036).

Conclusion: The PCA cementless THA has performed well beyond 20 years with 26 mm articulations doing better than 32 mm, and male gender associated with better outcomes. The authors postulate that polyethylene thickness is key to predicting failure.

Purpose: The purpose of this study was to investigate the mid to long term (minimum 10 years follow-up) survivorship of the AMK total knee arthroplasty (TKA), as well as determine the effect of implant fixation on outcome.

Method: Between 1988 and 2000, 1074 AMK primary total knee arthroplasties were preformed on 843 patients. All diagnosis included, the distribution was 90% osteoarthritis (971), 7% inflammatory arthritis (76) and 3% other diagnoses (27). Average time from surgery was 15 years (range 10–21 years). Average age at primary procedure was 68 years (range 22–99). Fifty-six percent were female (599) and 44% male (475). Preoperative alignment consisted of 56% varus (601) and 17% valgus (182). Ninety percent (968) had patella resurfacing performed, 62% (661) received cemented TKA fixation, on 32% hybrid fixation (cemented femoral component, cementless tibial tray) was performed and 6% (66) had cementless fixation. Two hundred thirty-seven cases were deceased before 20 years follow-up (22%).

Results: At 10 to 21 years follow-up, 129 revisions were performed (12%). The most common reasons for revision were polyethylene wear, particle induced osteolysis, instability and pain (43% of revisions). Implant fixation significantly influenced the rate of revision with cemented fixation having a 6.7% rate of revision (44/661), hybrid fixation a 14% revision rate (47/336) and cementless a 36.4% revision rate (24/66). Excluding infections (11 cases), overall Kaplan-Meier survivorship at five, 10 and 15 years was 96.4%, 91.9% and 85.8%, respectively. At 20 years the predicted Kaplan-Meier survivorship was estimated at 83.5% (no revisions beyond 17.5 years). Cemented fixation was associated with significantly better survivorship than hybrid and cementless fixation (p< 0.0001). At 5, 10 and 15 years cemented AMK TKA survivorship was 97.5%, 94.9% and 91.9% respectively (no revision performed beyond 13.5 years). For hybrid fixation the survival at 5, 10 and 15 years was 97.8%, 92.2% and 85.1% respectively. Cementless AMK THA had a Kaplan-Meier survivor-ship of 88.9%, 78.2% and 57.4% at 5, 10 and 15 years respectively.

Conclusion: Cemented fixation had superior outcomes compared to cementless and hybrid fixation with the most common reasons for revision being polyethylene wear and osteolysis. To our knowledge this the first medium to long term follow-up of the AMK TKA and it demonstrates that method of fixation had a major influence on revision rates and survivorship.

Purpose: Approximately, 10% of two-stage TKA revisions for deep sepsis become re-infected. The purpose of this study was to determine the success in terms of sepsis eradication and factors associated with failure of repeat two-stage revision TKA.

Method: Between 1991 and 2006, 129 two-stage revision TKRs for deep sepsis were performed. Ten cases which became re-infected were identified. These unfortunate patients, representing 8% of all the two-stage TKA revisions performed during this time period, are the focus of this study. Their progress and treatment interventions were followed for the purposes of this study.

Results: Ten patients were identified with a two-stage revision TKA which became re-infected. Mean patient age was 72 with 40 % being female. Following recurrent sepsis all patients went on to require more than one further two-stage revision (mean 3.67 further revision surgeries). Infection was only successfully eradicated in 28.7% of cases, the remaining require chronic suppressive therapy or have ongoing active infection. Two patients went on to have an arthrodesis (both remain on suppressive anti-biotics) and one patient had trans-femoral amputation. Staph Aureus and Coagulase neg Staph accounted for 80% of primary infective organisms with only one primary infection with methicillin resistant staph aureus (MRSA). Cultures at subsequent revisions were the same organism in 67% cases. Additional organism cultured included Pseudomonas and Propionibacterium. These patients had an increased incidence of multiple medical co-morbidities including Type-2 Diabetes Mellitus and Rheumatoid Arthritis.

Conclusion: Patients with recurrent sepsis after a two-stage revision for infection in TKR all required multiple further surgeries. Eradication of infection was only achieved in 28.7% cases. Risk factors for recurrent sepsis include Rheumatoid Arthritis and Type-2 Diabetes Mellitus.

Purpose: There is no consensus whether the posterior cruciate ligament (PCL)should be preserved (CR) or sacrificed (CS) during primary total knee replacement (TKR). The purpose of this study was to compare the greater than 10 year survivorship and health related outcomes of CR and CS TKRs using a single implant system.

Method: Between 1996 and 2000, 478 Genesis II Primary TKRs were inserted in 414 patients. Excluding those with a primary diagnosis other than osteoarthritis, body mass index greater then 40, history of prior patellectomy, fusion or osteotomy, 358 cases in 310 patients were included. 134 (37%) had a PCL preserving (CR) and 224 (63%) had a PCL sacrificing implant (CS). The two patient cohorts were compared for Kaplan-Meier survivorship, health-related outcomes (Knee Society scores, WOMAC, SF-12), range of motion (ROM) and radiographic loosening or wear.

Results: Mean follow-up was 11.87±1.04 years for CR and 10.96±0.87 years for CS (p=0.001). Four cases were revised for infection. No significant differences were noted between the CR and CS Genesis II cohorts at 10 year Kaplan-Meier survivorship excluding infections (CR 0.984±0.011, CS 0.986±0.008, p=0.30). Overall revisions were two for CR (1.5%, no infections) and seven for CS (1.7%, four for infection; 1.3% excluding infections). Revision rates were not significantly different between groups including or excluding infections (p=0.493 and p=1.00 respectively). CS had significantly greater postoperative ROM than CR (CS=114.20±13.60, CR=111.35±12.38, p=0.024). At 10 years, no differences were observed in satisfaction, health-related outcomes or radiographic wear/loosening. Crepitus was reported more frequently in CS design.

Conclusion: Most studies comparing PCL sacrificing (CS) versus retaining (CR) TKRs are short term. In this large, long term, single implant CR versus CS study, no differences were found in Kaplan-Meier survivorship, health-related outcomes or patient satisfaction. The CS design had more range of motion, but also a higher incidence of peripatellar crepitus than the CR design. We conclude that both CR and CS TKR designs can yield excellent long term clinical outcomes.

Purpose: High contact stresses and wear after total knee replacement (TKR) has been a problem. Mobile bearing TKRs have been advocated as a means to increase load bearing area, reduce contact stresses and minimize wear. The purpose of this study was to compare two, large, consecutive cohorts of TKR patients with greater than 10 years follow-up, one with a fixed bearing and one with a mobile bearing design.

Method: One hundred and three SAL II mobile bearing TKR’s were compared to a gender, age, BMI and time from surgery matched fixed bearing Genesis II cohort of equal size. All surgeries were performed between September 1993 and December 2000 (average follow-up, 11.64±1.64 years). Inclusion criteria included patients with osteoarthritis of the knee. Exclusion criteria included revision arthroplasty, inflammatory arthritis, a prior osteotomy or a prior patellectomy. The > 10 year Kaplan-Meier survivorship, health-related outcomes (Knee Society scores, WOMAC and SF-12), radiographs and retrieved implants for the fixed and mobile bearing TKR cohorts were compared.

Results: Fixed bearing TKRs demonstrated better 10 year Kaplan-Meier survivorships for any re-operation, 1.000±0.000 compared to 0.969±0.018 for mobile bearings (Genesis II and SAL I/II respectively). Revision rates were significantly different between groups with fixed bearing having no revisions and mobile four revisions (3.9%). No cases were revised for sepsis. Mobile bearing revisions were for pain (1), patellar maltracking (1), polyethylene wear (1) and aseptic loosening (1). At 10 years, health-related outcomes were similar between the two cohorts. Fixed bearing TKRs demonstrated more range of motion (111.42±12.76 vs 107.19±14.74 degrees) although not significant (p=0.052). Wear was more frequently noted in mobile bearing TKRs on > 10 year radiographs.

Conclusion: In this comparison of two contemporary TKRs, the fixed bearing TKR outperformed the mobile bearing TKR.

Purpose: The Synergy femoral component was introduced in late 1996 as a second generation titanium proximally porous-coated tapered stem with dual offsets (standard & high) to help better restore femoral offset at THR. The purpose of this prospective study was to evaluate the long-term (minimum 10 year) clinical and radiographic results and survivorship of this second-generation femoral component at our institution.

Method: From December 1996 to December 1999, 256 cementless Synergy femoral components were inserted and followed prospectively in 254 patients requiring THR. 185 were standard offset stems(72.3%) while 71 stems (27.7%) were high offset. The average follow-up was 11.2 years (range 10.0 to 12.9 years). Average age at index THR was 58.9 years (range 19 to 86 years). Two hundred eight stems had standard porous coating while 48 had additional HA coating. Fifty-two cases were either lost to follow-up or had died prior to 10 years follow-up. Patients were followed prospectively using validated clinical outcome scores (WOMAC, SF-12, Harris Hip scores) and radiographs. Kaplan-Meier survival analysis was performed.

Results: All health-related outcomes were significantly improved from pre-operative with a mean Harris Hip score and WOMAC at last follow-up of 91.6 and 81.8, respectively. From the initial 256 femoral stems inserted, only 5 stems have been revised. Two stems have been revised for infection. To date, only one stem has been revised due to subsidence at nine months following surgery likely, as a result of a calcar fracture occurring at the index THR. Two stems were revised for peri-prosthetic fracture as a result of patient falls at six months and 9.8 years post-op. Radiographic review of remaining stems in-situ identified no cases of loosening with all stems showing evidence of osseous integration. The Kaplan-Meier survivorship analysis of the femoral component, with revision for aseptic loosening, was 99.2%±0.008 at five, 10 and 12 years.

Conclusion: The Synergy femoral component, a second generation titanium proximally porous-coated tapered stem design with dual offsets, has demonstrated excellent clinical & radiographic results and long-term survivorship (99% at 10 years) at our institution.

Purpose: The purpose of this prospective blinded randomized control trial was to compare the stem migration of two cemented stem designs using radiostereometric analysis (RSA). This was essentially a safety study in which our hypothesis was that the newer design (CPCS, Smith and Nephew Inc) would demonstrate similar micro-motion to the well-established Exeter (Stryker) design.

Method: Thirty patients were consented and enrolled into a blinded RCT in which 15 patients received a dedicated RSA CPCS stem and 15 patients received a RSA Exeter stem. Both stems are collarless tapered polished cemented stems, the only difference being a slight lateral to medial taper with the CPCS design. Outcome measures were compared (Hip Society Score, WOMAC, SF-12). RSA analysis was conducted immediately postoperatively, at 6 weeks, 3 months, 6 months, 1 year and 2 years.

Results: No difference was found in any of the outcome measures pre-operatively or postoperatively. At 2 years, stem subsidence for the CPCS stem was approximately half that seen for the Exeter stem (0.565±0.189mm and 0.981±0.209mm respectively, p< 0.0001). In contrast, posterior (internal) rotation of the CPCS was approximately twice that of the Exeter stem (1.496±1.215° and 0.716±0.818° respectively, p=0.221). Other migration patterns were no different between stems.

Conclusion: As expected with this stem design, both stems showed some axial and rotational migration within the cement mantle. The subtle differences in design may explain the differences in migration patterns. Our data suggests that the newer CPCS design should perform well over the long-term.

Purpose: The growing trend of morbidly obese (BMI 40+) patients requiring a total joint replacement is becoming major concern in total knee Arthroplasty (TKA). The purpose of this study was to investigate the affects that BMI may have on implant longevity and clinical patient outcome using historical patient data.

Method: A consecutive cohort of 3083 TKA’s in 2048 patients since 1995 (minimum 2 years follow-up) were evaluated. Pre-operative scores, latest scores, and change in clinical outcome scores (KSCRS, SF12, WOMAC) were analyzed using ANOVA and Kaplan-Meier (K-M) survivorship was determined.

Results: K-M cumulative survival at 10 years by BMI group was 0.951±0.033 for Normal and Underweight (< 25, n=277), 0.944±0.024 for Overweight (25–29.9, n=915), 0.882±0.032 for Obese (30–39.9, n=1460) and 0.843±0.076 for Morbidly Obese (40+, n=352). Cumulative revision rates were 1.8% for Normal and Underweight, 1.9% for Overweight, 2.9% for Obese and 2.8% for Morbidly Obese. All pre-operative clinical scores were significantly different between the Morbidly Obese and all other BMI groups (p< 0.05), with the non-morbidly obese having higher scores in all cases. Significant difference was found in the change in WOMAC domain scores and the KSCRS knee score (p< 0.05) between the morbidly obese group and all other BMI groups, with the morbidly obese having the greatest improvement in all domains.

Conclusion: The morbidly obese patient cohort (BMI > 40) undergoing TKA demonstrated the most significant improvement in clinical outcome scores; however also had the lowest cumulative 10 year survivorship. This risk/benefit information is important in pre-operative discussions with this challenging, and increasingly prevalent, patient population.

Purpose: The purpose of this study was to determine why some TKR patients are satisfied and others are dissatisfied.

Method: 2,481 primary TKR patients who had completed a decision date WOMAC were randomly identified within the Ontario Joint Replacement Registry (OJRR) database. One year post-operatively, these patients were mailed a survey to determine satisfaction/expectations, willingness to undergo surgery again, Jaeschke self-reported clinical improvement, WOMAC scores and complications. The satisfied and not satisfied patient groups were identified, statistical analysis employed to determine variables that individually affect satisfaction and logistic regression used to identify significant factors which might lead to patient dissatisfaction.

Results: Only 70% of primary TKR patients felt that their expectations had been met and 15% reported that they had no expectations. Only 81% of patients reported that they were satisfied with their TKR. When asked whether they would have their surgery again, 96% of the satisfied patients reported that they would do so as compared to only 63% in the dissatisfied group (p< 0.0001). Using the Jaeschke self-reported clinical improvement scale, 87% of TKR patients reported that they were improved, but only 75% reported that they were a good, great or a very great deal improved. There was a high correlation with the WOMAC change score and the Jaeschke self-reported improvement and willingness to undergo surgery again questions. Significant differences were found between the satisfied and dissatisfied TKR patients in terms of a pre-operative WOMAC score of < 20 (p< 0.004), the WOMAC change score (p< 0.0001), expectations (p< 0.0001), complications (p< 0.0001), age (p< 0.002), referral status (p< 0.0005), living alone (p< 0.01) and comorbidities (p< 0.05). Logistic regression suggested that the most important predictive factors were a pre-operative WOMAC < 20 (p< 004), the WOMAC change score (p< 0.0001), expectations met (p< 0.0001) and complications (p< 0.0001).

Conclusion: Only one in five primary TKR patients are satisfied with their operative procedure. Significant risk factors for patient dissatisfaction after primary TKR include a pre-operative WOMAC < 20, a WOMAC change score of less than 33 points, expectations that were not met or a complication.