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Trauma

A RANDOMIZED TRIAL COMPARING GENDER SPECIFIC WITH GENDER NON SPECIFIC KNEE ARTHROPLASTY IMPLANTS

European Federation of National Associations of Orthopaedics and Traumatology (EFORT) - 12th Congress



Abstract

Introduction

We compared standard NexGen Cruciate substituting-flex prosthesis with gender-specific NexGen Cruciate substituting flex prosthesis in patients undergoing bilateral total knee arthroplasty with regard to Coverage of the bone by femoral component, Clinical outcome, Radiographic outcome, Survival and complication rates, with special emphasis on patellofemoral complications.

Material & Methods

30 female patients with osteo-arthritis of the knees with similar deformity and preoperative range of motion were randomized to have one knee replaced with a gender non-specific Nexgen Cruciate substituting (Zimmer) prosthesis and the other with Gender Cruciate substituting (Zimmer) prosthesis. Follow-up clinical evaluation was done at 6, and 12 months postoperatively and then at yearly interval using “Knee Society” Recommendations. Clinical assessment of the patellofemoral joint of the replaced knees was done with the help of “Hospital for Special Surgery” patellar scoring system. The overall patient satisfaction after surgery was evaluated with use of the British Orthopaedic Association patient satisfaction score.

Results

The mean age was 63.8 years (range 49–76 years). 14 patients had standard NexGen Cruciate substituting-flex gender knee prosthesis on right side and 16 patients had on left side. On the other sides, standard NexGen Cruciate substituting-flex prosthesis implant was used. Preop Clinical findings were similar in both groups. The average Preop range of motion was identical in both the groups. The average follow up was 2.5 years (2–3.8 years). The mean post-operative Knee Society knee scores were 88,90,94, (70 to 100) and 87,92, 93 (70 to 100) points and the function scores were 83,85,88 (60 to 100) and 84.86.88 (60 to 100) points for the standard implants and the gender-specific designs, respectively at 6 months, 1 year and 2 year follow up. Mean improvement in patella score was 65, 71.1 and 73.3 points in Gender group at the end of 6 month, 1 yr and 2 yr respectively as compared to 65.6, 71.1 and 72.2 in Nexgen group. No patient had malpositioning of components or radiolucencies at the end of 2 year follow up. Mean improvement in BOA functional score was 20.6, 22.6 and 24.1 points in Gender group at the end of 6 months, 1 year and 2 year respectively as compared to 20.7, 21.8 and 23.2 in Nexgen group. In those with a standard prosthesis, the femoral component was closely matched in 30 knees, overhung in 17 and undercovered the bone in 13. In those with a gender-specific prosthesis, it was closely matched in 45 knees and undercovered the bone in 15.

Conclusion

Although gender specific knee matched the femoral anatomy of Indian female knees better than the standard nexgen Knee, we found no significant differences between the two groups with regard to the clinical and radiological results, patient satisfaction or complication rate.