Department of Orthopaedic Surgery, Joint Research, OLVG Amsterdam, Amsterdam, the Netherlands.
Department of Human Movement Sciences, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands.
JAMA Netw Open. 2022 Jul 1;5(7):e2220394. doi: 10.1001/jamanetworkopen.2022.20394.
There is a paucity of high-quality evidence about the long-term effects (ie, 3-5 years and beyond) of arthroscopic partial meniscectomy vs exercise-based physical therapy for patients with degenerative meniscal tears.
To compare the 5-year effectiveness of arthroscopic partial meniscectomy and exercise-based physical therapy on patient-reported knee function and progression of knee osteoarthritis in patients with a degenerative meniscal tear.
DESIGN, SETTING, AND PARTICIPANTS: A noninferiority, multicenter randomized clinical trial was conducted in the orthopedic departments of 9 hospitals in the Netherlands. A total of 321 patients aged 45 to 70 years with a degenerative meniscal tear participated. Data collection took place between July 12, 2013, and December 4, 2020.
Patients were randomly allocated to arthroscopic partial meniscectomy or 16 sessions of exercise-based physical therapy.
The primary outcome was patient-reported knee function (International Knee Documentation Committee Subjective Knee Form (range, 0 [worst] to 100 [best]) during 5 years of follow-up based on the intention-to-treat principle, with a noninferiority threshold of 11 points. The secondary outcome was progression in knee osteoarthritis shown on radiographic images in both treatment groups.
Of 321 patients (mean [SD] age, 58 [6.6] years; 161 women [50.2%]), 278 patients (87.1%) completed the 5-year follow-up with a mean follow-up time of 61.8 months (range, 58.8-69.5 months). From baseline to 5-year follow-up, the mean (SD) improvement was 29.6 (18.7) points in the surgery group and 25.1 (17.8) points in the physical therapy group. The crude between-group difference was 3.5 points (95% CI, 0.7-6.3 points; P < .001 for noninferiority). The 95% CI did not exceed the noninferiority threshold of 11 points. Comparable rates of progression of radiographic-demonstrated knee osteoarthritis were noted between both treatments.
In this noninferiority randomized clinical trial after 5 years, exercise-based physical therapy remained noninferior to arthroscopic partial meniscectomy for patient-reported knee function. Physical therapy should therefore be the preferred treatment over surgery for degenerative meniscal tears. These results can assist in the development and updating of current guideline recommendations about treatment for patients with a degenerative meniscal tear.
ClinicalTrials.gov Identifier: NCT01850719.
对于退行性半月板撕裂患者,关节镜下半月板部分切除术与基于运动的物理治疗相比,长期效果(即 3-5 年及以后)的高质量证据很少。
比较关节镜下半月板部分切除术和基于运动的物理治疗对退行性半月板撕裂患者膝关节功能和膝关节骨关节炎进展的 5 年疗效。
设计、地点和参与者:这是一项非劣效性、多中心随机临床试验,在荷兰 9 家医院的骨科进行。共有 321 名年龄在 45 至 70 岁之间的退行性半月板撕裂患者参与。数据收集于 2013 年 7 月 12 日至 2020 年 12 月 4 日之间进行。
患者被随机分配接受关节镜下半月板部分切除术或 16 次基于运动的物理治疗。
主要结局是基于意向治疗原则的 5 年随访期间患者报告的膝关节功能(国际膝关节文献委员会主观膝关节评分(范围,0 [最差]至 100 [最佳]),非劣效性阈值为 11 分。次要结局是两组放射图像上显示的膝关节骨关节炎进展。
在 321 名患者(平均[标准差]年龄,58[6.6]岁;161 名女性[50.2%])中,278 名(87.1%)完成了 5 年随访,平均随访时间为 61.8 个月(范围,58.8-69.5 个月)。从基线到 5 年随访,手术组的平均(标准差)改善为 29.6(18.7)分,物理治疗组为 25.1(17.8)分。两组间的粗差值为 3.5 分(95%置信区间,0.7-6.3 分;P<.001 表示非劣效性)。95%置信区间未超过 11 分的非劣效性阈值。两种治疗方法的放射学显示的膝关节骨关节炎进展率相当。
在这项非劣效性随机临床试验中,5 年后,基于运动的物理治疗在患者报告的膝关节功能方面仍然不劣于关节镜下半月板部分切除术。因此,对于退行性半月板撕裂,物理治疗应优于手术。这些结果可以帮助制定和更新当前关于退行性半月板撕裂患者治疗的指南建议。
ClinicalTrials.gov 标识符:NCT01850719。