Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
Centre for Deformity Correction and Joint Preserving Surgery, Kliniek ViaSana, Mill, The Netherlands.
PLoS One. 2020 Jan 22;15(1):e0227975. doi: 10.1371/journal.pone.0227975. eCollection 2020.
Knee joint distraction (KJD) has been evaluated as a joint-preserving treatment to postpone total knee arthroplasty in knee osteoarthritis patients in three clinical trials. Since 2014 the treatment is used in regular care in some hospitals, which might lead to a deviation from the original indication and decreased treatment outcome. In this study, baseline characteristics, complications and clinical benefit are compared between patients treated in regular care and in clinical trials.
In our hospital, 84 patients were treated in regular care for 6 weeks with KJD. Surgical details, complications, and range of motion were assessed from patient hospital charts. Patient-reported outcome measures were evaluated in regular care before and one year after treatment. Trial patients (n = 62) were treated and followed as described in literature.
Patient characteristics were not significantly different between groups, except for distraction duration (regular care 45.3±4.3; clinical trials 48.1±8.1 days; p = 0.019). Pin tract infections were the most occurring complication (70% regular care; 66% clinical trials), but there was no significant difference in treatment complications between groups (p>0.1). The range of motion was recovered within a year after treatment for both groups. WOMAC questionnaires showed statistically and clinically significant improvement for both groups (both p<0.001 and >15 points in all subscales) and no significant differences between groups (all differences p>0.05). After one year, 70% of patients were responders (regular care 61%, trial 75%; p = 0.120). Neither regular care compared to clinical trial, nor any other characteristic could predict clinical response.
KJD as joint-preserving treatment in clinical practice, to postpone arthroplasty for end-stage knee osteoarthritis patient below the age of 65, results in an outcome similar to that thus far demonstrated in clinical trials. Longer follow-up in regular care is needed to test whether also long-term results remain beneficial and comparable to trial data.
膝关节牵张术（KJD）已在三项临床试验中被评估为一种保留关节的治疗方法，以推迟膝骨关节炎患者的全膝关节置换术。自 2014 年以来，该治疗方法已在一些医院的常规护理中使用，这可能导致偏离原始适应证和治疗效果降低。在这项研究中，我们比较了在常规护理和临床试验中接受治疗的患者的基线特征、并发症和临床获益。
在我们医院，84 例患者在常规护理下接受 KJD 治疗 6 周。从患者的住院病历中评估手术细节、并发症和活动范围。在常规护理中，在治疗前和治疗后 1 年评估患者报告的结局测量指标。试验患者（n=62）按照文献中的描述进行治疗和随访。
两组患者的特征无显著差异，除了牵张时间（常规护理 45.3±4.3；临床试验 48.1±8.1 天；p=0.019）。钉道感染是最常见的并发症（常规护理 70%；临床试验 66%），但两组之间的治疗并发症无显著差异（p>0.1）。两组患者在治疗后一年内均恢复了活动范围。WOMAC 问卷显示两组均有统计学和临床显著改善（所有亚量表均 p<0.001，且均>15 分），且两组之间无显著差异（所有差异 p>0.05）。一年后，70%的患者为应答者（常规护理 61%，试验 75%；p=0.120）。常规护理与临床试验相比，或任何其他特征均不能预测临床反应。
在临床实践中，作为保留关节的治疗方法，KJD 用于推迟 65 岁以下终末期膝骨关节炎患者的关节置换术，结果与迄今为止在临床试验中显示的结果相似。在常规护理中需要进行更长时间的随访，以测试长期结果是否仍然有益且与试验数据相媲美。
