Faculty of Health, University of Canberra, Australian Capital Territory, Australia; Trauma and Orthopaedic Research Unit, Canberra Hospital, Australian Capital Territory, Australia.
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.
J Arthroplasty. 2017 Nov;32(11):3356-3363.e1. doi: 10.1016/j.arth.2017.05.032. Epub 2017 May 22.
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.
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.
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).
There was no evidence of clinical superiority of one implant over the other at 2 years.
双髁稳定（BCS）膝关节置换术的发展是为了复制正常的膝关节运动学。我们假设，与已确立的后交叉稳定植入物相比，需要全膝关节置换术（TKA）的骨关节炎患者使用 BCS 植入物将具有更好的功能结果和满意度。
这项多中心、随机、对照试验比较了 BCS 植入物与已确立的后交叉稳定植入物的临床结果，随访时间为 2 年。在等待原发性膝关节骨关节炎进行膝关节置换的患者中，228 名患者被随机分为接受后稳定或 BCS 植入物。主要结果是膝关节屈曲度和牛津膝关节评分。次要结果是并发症和不良事件（AE）的发生率。三级结果包括膝关节学会评分、加利福尼亚大学洛杉矶分校活动评分、髌骨评分、EQ-5D、6 分钟步行时间和患者满意度。
记录了 98 个后稳定植入物和 97 个 BCS 植入物的完整数据。12 名患者有双侧膝关节植入物。在任何一年的任何测量指标中，两组之间均无差异。在 2 年时，后稳定植入物的膝关节屈曲度为 119±0.16°，BCS 植入物为 120±1.21°（平均值，标准误差，P=0.538），牛津膝关节评分分别为 40.4±0.69 和 40.0±0.67（P=0.828）。两组中均有类似的与器械相关的 AE 和翻修（AE 分别为 18 例和 22 例，P=0.732；翻修分别为 3 例和 4 例，P=0.618）。
在 2 年时，没有证据表明一种植入物比另一种具有临床优势。
