Massachusetts General Hospital Department of Orthopaedic Surgery, Sports Medicine Center, Boston, Massachusetts, USA.
Department of Orthopaedic Surgery, University of Kentucky, Lexington, Kentucky, USA.
Am J Sports Med. 2021 Apr;49(5):1199-1208. doi: 10.1177/0363546521990789. Epub 2021 Mar 3.
Previous observational studies have suggested poor results of arthroscopic surgery for the treatment of acetabular labral tears in patients older than 40 years.
To compare hip arthroscopy versus nonoperative management for symptomatic labral tears in patients older than 40 years who have limited radiographic osteoarthritis.
Randomized controlled trial; Level of evidence, 1.
In this single-surgeon, parallel randomized controlled trial, patients older than 40 years who had symptomatic, MRI-confirmed labral tears and limited radiographic osteoarthritis (Tönnis grades 0-2) were randomized 1:1 to arthroscopic surgery with postoperative physical therapy (SPT) or physical therapy alone (PTA) using an electronic randomization program. PTA patients who achieved unsatisfactory improvement were permitted to cross over to SPT after completing ≥14 weeks of physical therapy. The primary outcomes were International Hip Outcome Tool (iHOT-33) and modified Harris Hip Score (mHHS) at 12 months after randomization, and secondary outcomes included other patient-reported outcome measures and the visual analog scale. Outcomes were assessed at baseline and at 3, 6, and 12 months after randomization. Primary analysis was performed on an intention-to-treat basis using linear mixed-effect models. Sensitivity analyses included modified as-treated analysis and treatment-failure analysis. Due to infeasibility, patients and health care providers were both unblinded.
The study enrolled 90 patients (46 [51.1%] SPT; 44 [48.9%] PTA); of these, 81 patients (42 [51.9%] SPT; 39 (48.1%) PTA) completed 12-month follow-up. A total of 28 of the 44 PTA patients crossed over to SPT within the study period (63.6% crossover). Intention-to-treat analysis revealed significantly greater iHOT-33 scores (+12.11; = .007) and mHHS scores (+6.99 points; = .04) in the SPT group than the PTA group at 12 months. Modified as-treated analysis revealed that these differences exceeded the minimal clinically important difference of 10.0 points (SPT-PTA iHOT-33, +11.95) and 8.0 points (SPT-PTA mHHS, +9.76), respectively.
In patients older than 40 years with limited osteoarthritis, arthroscopic acetabular labral repair with postoperative physical therapy led to better outcomes than physical therapy alone. Thus, age over 40 years should not be considered a contraindication to arthroscopic acetabular labral repair.
NCT03909178 (ClinicalTrials.gov identifier).
先前的观察性研究表明，对于 40 岁以上患者的髋关节镜手术治疗髋臼唇撕裂效果不佳。
比较髋关节镜手术与非手术治疗对有症状的髋臼唇撕裂且影像学局限性骨关节炎（Tönnis 分级 0-2 级）的 40 岁以上患者的效果。
随机对照试验；证据等级，1 级。
在这项单外科医生、平行随机对照试验中，招募了有症状、MRI 证实的髋臼唇撕裂且影像学局限性骨关节炎（Tönnis 分级 0-2 级）的 40 岁以上患者，按 1:1 比例随机分为关节镜手术联合术后物理治疗（SPT）或单纯物理治疗（PTA）组，使用电子随机分组程序。PTA 患者如果在完成至少 14 周的物理治疗后仍未达到满意的改善，则允许交叉到 SPT 组。主要结局指标为随机分组后 12 个月时的国际髋关节结果工具（iHOT-33）和改良 Harris 髋关节评分（mHHS），次要结局指标包括其他患者报告结局指标和视觉模拟评分。在基线时和随机分组后 3、6 和 12 个月时进行评估。主要分析采用意向治疗原则，使用线性混合效应模型进行。敏感性分析包括修正后处理分析和治疗失败分析。由于不切实际，患者和医疗保健提供者均未设盲。
该研究纳入了 90 例患者（SPT 组 46 例[51.1%]；PTA 组 44 例[48.9%]），其中 81 例患者（SPT 组 42 例[51.9%]；PTA 组 39 例[48.1%]）完成了 12 个月的随访。在研究期间，共有 44 例 PTA 患者中的 28 例（63.6%）交叉到 SPT 组。意向治疗分析显示，SPT 组的 iHOT-33 评分（+12.11； =.007）和 mHHS 评分（+6.99 分； =.04）在 12 个月时显著高于 PTA 组。修正后处理分析显示，这些差异超过了 10.0 分（SPT-PTA iHOT-33，+11.95）和 8.0 分（SPT-PTA mHHS，+9.76）的最小临床重要差异。
对于影像学局限性骨关节炎的 40 岁以上患者，关节镜髋臼唇修复术后联合物理治疗比单纯物理治疗效果更好。因此，40 岁以上不应该被认为是关节镜髋臼唇修复术的禁忌证。
NCT03909178（ClinicalTrials.gov 标识符）。
