Jennie M Scarvell1, Diana M Perriman2, Paul N Smith3, David G Campbell4, Warwick J M Bruce5, Bo Nivbrant6. 1. Faculty of Health, University of Canberra, Australian Capital Territory, Australia; Trauma and Orthopaedic Research Unit, Canberra Hospital, Australian Capital Territory, Australia. 2. Faculty of Health, University of Canberra, Australian Capital Territory, Australia; Trauma and Orthopaedic Research Unit, Canberra Hospital, Australian Capital Territory, Australia; ANU Medical School, Australian National University, Australian Capital Territory, Australia. 3. Trauma and Orthopaedic Research Unit, Canberra Hospital, Australian Capital Territory, Australia; ANU Medical School, Australian National University, Australian Capital Territory, Australia. 4. School of Medicine, Flinders University, Adelaide, South Australia, Australia; Wakefield Orthopaedic Clinic, Adelaide, South Australia, Australia. 5. Hip and Knee Clinic, New South Wales, Australia. 6. Faculty of Health and Medical Sciences, University of Western Australia, Perth, Western Australia, Australia; Department of Surgery, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia; Mount Hospital, Perth, Western Australia, Australia.
Abstract
BACKGROUND: The bicruciate-stabilized (BCS) knee arthroplasty was developed to replicate normal knee kinematics. We examined the hypothesis that patients with osteoarthritis requiring total knee arthroplasty (TKA) will have better functional outcome and satisfaction with the BCS implant compared with an established posterior cruciate-stabilized implant. METHODS: This multicenter, randomized, controlled trial compared the clinical outcomes of a BCS implant against an established posterior cruciate-stabilized implant with 2-year follow-up. Of the patients awaiting primary knee arthroplasty for osteoarthritis, 228 were randomized to receive either a posterior-stabilized or BCS implant. Primary outcomes were knee flexion and Oxford Knee Score. Secondary outcomes were rate of complications and adverse events (AEs). Tertiary outcomes included Knee Society Score, University of California, Los Angeles, activity score, Patella scores, EQ-5D, 6-minute walk time, and patient satisfaction. RESULTS: Complete data were recorded for 98 posterior-stabilized implants and 97 BCS implants. Twelve patients had bilateral knee implants. There was no difference between the groups for any of the measures at either 1 or 2 years. At 2 years, knee flexion was 119 ± 0.16 and 120 ± 1.21 degrees for the posterior-stabilized and BCS implants, respectively, (mean, standard error, P = .538) and Oxford Knee Scores were 40.4 ± 0.69 and 40.0 ± 0.67 (P = .828), respectively. There were similar device-related AEs and revisions in each group (AEs 18 vs 22; P = .732; revisions 3 vs 4; P = .618). CONCLUSION: There was no evidence of clinical superiority of one implant over the other at 2 years.
RCT Entities:
BACKGROUND: The bicruciate-stabilized (BCS) knee arthroplasty was developed to replicate normal knee kinematics. We examined the hypothesis that patients with osteoarthritis requiring total knee arthroplasty (TKA) will have better functional outcome and satisfaction with the BCS implant compared with an established posterior cruciate-stabilized implant. METHODS: This multicenter, randomized, controlled trial compared the clinical outcomes of a BCS implant against an established posterior cruciate-stabilized implant with 2-year follow-up. Of the patients awaiting primary knee arthroplasty for osteoarthritis, 228 were randomized to receive either a posterior-stabilized or BCS implant. Primary outcomes were knee flexion and Oxford Knee Score. Secondary outcomes were rate of complications and adverse events (AEs). Tertiary outcomes included Knee Society Score, University of California, Los Angeles, activity score, Patella scores, EQ-5D, 6-minute walk time, and patient satisfaction. RESULTS: Complete data were recorded for 98 posterior-stabilized implants and 97 BCS implants. Twelve patients had bilateral knee implants. There was no difference between the groups for any of the measures at either 1 or 2 years. At 2 years, knee flexion was 119 ± 0.16 and 120 ± 1.21 degrees for the posterior-stabilized and BCS implants, respectively, (mean, standard error, P = .538) and Oxford Knee Scores were 40.4 ± 0.69 and 40.0 ± 0.67 (P = .828), respectively. There were similar device-related AEs and revisions in each group (AEs 18 vs 22; P = .732; revisions 3 vs 4; P = .618). CONCLUSION: There was no evidence of clinical superiority of one implant over the other at 2 years.