Roos Ewa M, Hare Kristoffer Borbjerg, Nielsen Sabrina Mai, Christensen Robin, Lohmander L Stefan
Department of Sport and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.
Department of Orthopaedics, Slagelse Hospital, Slagelse, Denmark.
BMJ Open. 2018 Feb 2;8(2):e019461. doi: 10.1136/bmjopen-2017-019461.
Compare arthroscopic partial meniscectomy to a true sham intervention.
Sham-controlled superiority trial performed in three county hospitals in Denmark comparing arthroscopic partial meniscectomy to skin incisions only in patients aged 35-55 years with persistent knee pain and an MRI-confirmed medial meniscus lesion. A computer-generated table of random numbers generated two comparison groups. Participants and outcome assessors were blinded to group allocation. Exclusions were locking knees, high-energy trauma or severe osteoarthritis. Outcomes were collected at baseline, 3 and 24 months. We hypothesised no difference between groups. The primary outcome was the between-group difference in change from baseline to 2 years in the mean score across all five normalised Knee injury and Osteoarthritis Outcome Score (KOOS) subscales (KOOS).
Forty-four patients (of the estimated 72) underwent randomisation; 22 in each group. Sixteen participants (36%) were non-blinded and eight participants (36%) from the sham group crossed over to the surgery group prior to the 2-year follow-up. At 2 years, both groups reported clinically relevant improvements (surgery 21.8, skin incisions only 13.6), the mean difference between groups was 8.2 in favour of surgery, which is slightly less than the cut-off of 10 prespecified to represent a clinically relevant difference; judged by the 95% CI (-3.4 to 19.8), a possibility of clinically relevant difference could not be excluded. In total, nine participants experienced 11 adverse events; six in the surgery group and three in the skin-incisions-only group.
We found greater improvement from arthroscopic partial meniscectomy compared with skin incisions only at 2 years, with the statistical uncertainty of the between-group difference including what could be considered clinically relevant. Because of the study being underpowered, nearly half in the sham group being non-blinded and one-third crossing over to surgery, the results cannot be generalised to the greater patient population.
NCT01264991.
比较关节镜下部分半月板切除术与真正的假手术干预。
在丹麦的三家县级医院进行了一项假手术对照的优效性试验，将关节镜下部分半月板切除术与仅做皮肤切口的手术在年龄35 - 55岁、患有持续性膝关节疼痛且经磁共振成像（MRI）确诊为内侧半月板损伤的患者中进行比较。通过计算机生成的随机数字表产生两个比较组。参与者和结果评估者对分组情况不知情。排除标准为膝关节交锁、高能创伤或重度骨关节炎。在基线、3个月和24个月时收集结果。我们假设两组之间无差异。主要结局是所有五个标准化的膝关节损伤和骨关节炎结局评分（KOOS）子量表的平均得分从基线到2年的组间变化差异。
（估计的72名患者中的）44名患者进行了随机分组；每组22名。16名参与者（36%）未被成功设盲，并且在2年随访前，假手术组中有8名参与者（36%）转而接受手术组治疗。在2年时，两组均报告了具有临床意义的改善（手术组21.8，仅皮肤切口组13.6），组间平均差异为8.2，有利于手术组，略低于预先设定的代表临床相关差异的临界值10；根据95%置信区间（-3.4至19.8）判断，不能排除存在临床相关差异的可能性。总共9名参与者经历了11次不良事件；手术组6次，仅皮肤切口组3次。
我们发现与仅做皮肤切口相比，关节镜下部分半月板切除术在2年时改善更大，组间差异存在统计学不确定性，包括可能被认为具有临床意义的差异。由于该研究样本量不足、假手术组近一半未被设盲且三分之一转而接受手术治疗，因此结果不能推广至更广泛的患者群体。
NCT01264991。
