Hamilton Thomas W, Lineham Beth, Stocken Deborah D, Pandit Hemant, Muli A, Kelly R, Collier H, Mujica-Mota R, Metcalfe A, Simpson H, Murray D W, Sharma H, McGonagle D, Ellard D R, Croft J, Stokes J, Harwood P
Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
Bone Jt Open. 2025 Aug 6;6(8):886-893. doi: 10.1302/2633-1462.68.BJO-2024-0120.R2.
Knee joint distraction (KJD) has been proposed as a joint-preserving alternative to arthroplasty. The objective of this study was to evaluate the clinical and cost-effectiveness of KJD compared to arthroplasty for knee osteoarthritis.
This phase III multicentre, pragmatic, randomized controlled non-inferiority trial recruited adults aged ≤ 65 years with symptomatic osteoarthritis refractory to non-surgical treatment and suitable for knee arthroplasty. Patients were randomized to static, linear, KJD of 5 mm, produced with an external fixator construct for six-week duration, or total knee arthroplasty. The primary outcome measure was the Knee injury and Osteoarthritis Outcomes Score (KOOS) pain subscale 12 months post-surgery. The trial was terminated early due to failure to recruit following cessation of elective orthopaedic surgery during the COVID-19 pandemic.
A total of 24 participants were randomized with baseline characteristics balanced between groups. Improved median KOOS pain scores at 12 months postoperatively were observed in both treatment groups. The median KOOS pain score in the KJD group improved from 38.9 (IQR 30.6 to 41.7) at baseline to 55.6 (IQR 41.7 to 94.4) at 12 months, while corresponding scores in the arthroplasty group improved from 30.6 (IQR 11.1 to 36.1) to 75.0 (IQR 66.7 to 88.9). Similar improvements following KJD were seen across other KOOS subdomains and pain VAS, range of motion, or timed up-and-go test. The small sample size does not provide sufficient information to make meaningful comparisons between treatment groups. Pin site infection was seen in two patients, and a fracture through a pin site after frame removal following trauma in one patient.
KJD appears to be associated with improved pain and function compared to baseline. The clinical and cost-effectiveness of KJD compared to arthroplasty remains uncertain.
膝关节撑开术（KJD）已被提议作为一种保留关节的关节置换替代方法。本研究的目的是评估与膝关节置换术相比，KJD治疗膝关节骨关节炎的临床疗效和成本效益。
这项III期多中心、实用、随机对照非劣效性试验招募了年龄≤65岁、患有症状性骨关节炎且非手术治疗无效且适合膝关节置换术的成年人。患者被随机分为使用外固定架装置进行为期六周的5毫米静态线性KJD组或全膝关节置换术组。主要结局指标是术后12个月的膝关节损伤和骨关节炎疗效评分（KOOS）疼痛子量表。由于在COVID-19大流行期间择期骨科手术停止后未能招募到足够患者，该试验提前终止。
共有24名参与者被随机分组，两组的基线特征均衡。两个治疗组术后12个月的KOOS疼痛评分中位数均有所改善。KJD组的KOOS疼痛评分中位数从基线时的38.9（四分位间距30.6至41.7）提高到12个月时的55.6（四分位间距41.7至94.4），而关节置换术组的相应评分从30.6（四分位间距11.1至36.1）提高到75.0（四分位间距66.7至88.9）。在其他KOOS子领域以及疼痛视觉模拟评分、活动范围或计时起立行走测试方面，KJD后也有类似改善。样本量较小，无法提供足够信息以在治疗组之间进行有意义的比较。两名患者出现针道感染，一名患者在创伤后拆除框架后针道处发生骨折。
与基线相比，KJD似乎与疼痛和功能改善相关。与关节置换术相比，KJD的临床疗效和成本效益仍不确定。
