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Arthroscopic Partial Meniscectomy versus Sham Surgery for a Degenerative Meniscal Tear
关节镜半月板部分切除术与假手术治疗退行性半月板撕裂
Author Info & Affiliations
作者：Raine Sihvonen， M.D.， Mika Paavola， M.D.， Ph.D.， Antti Malmivaara， M.D.， Ph.D.， Ari Itälä， M.D.， Ph.D.， Antti Joukainen， M.D.， Ph.D.， Heikki Nurmi， M.D.， Juha Kalske， M.D.， and Teppo L.N. Järvinen， M.D.， Ph.D.， 芬兰退行性半月板病变研究 （FIDELITY） 组作者信息和隶属关系
作者：Raine Sihvonen， M.D.， Mika Paavola， M.D.， Ph.D.， Antti Malmivaara， M.D.， Ph.D.， Ari Itälä， M.D.， Ph.D.， Antti Joukainen， M.D.， Ph.D.， Heikki Nurmi， M.D.， Juha Kalske， M.D.， and Teppo L.N. Järvinen， M.D.， Ph.D.， 芬兰退行性半月板病变研究 （FIDELITY） 组作者信息和隶属关系
Published December 26, 2013
2013 年 12 月 26 日发布
2013 年 12 月 26 日发布
N Engl J Med 2013;369:2515-2524
DOI: 10.1056/NEJMoa1305189
DOI： 10.1056/NEJMoa1305189
DOI： 10.1056/NEJMoa1305189
Abstract 抽象
Background 背景
Arthroscopic partial meniscectomy is one of the most common orthopedic procedures, yet rigorous evidence of its efficacy is lacking.
关节镜下半月板部分切除术是最常见的骨科手术之一，但缺乏对其疗效的严格证据。
关节镜下半月板部分切除术是最常见的骨科手术之一，但缺乏对其疗效的严格证据。
Methods 方法
We conducted a multicenter, randomized, double-blind, sham-controlled trial in 146 patients 35 to 65 years of age who had knee symptoms consistent with a degenerative medial meniscus tear and no knee osteoarthritis. Patients were randomly assigned to arthroscopic partial meniscectomy or sham surgery. The primary outcomes were changes in the Lysholm and Western Ontario Meniscal Evaluation Tool (WOMET) scores (each ranging from 0 to 100, with lower scores indicating more severe symptoms) and in knee pain after exercise (rated on a scale from 0 to 10, with 0 denoting no pain) at 12 months after the procedure.
我们在 146 名 35 至 65 岁的患者中进行了一项多中心、随机、双盲、假对照试验，这些患者的膝关节症状符合退行性内侧半月板撕裂，且没有膝骨关节炎。患者被随机分配到关节镜下半月板部分切除术或假手术组。主要结局是Lysholm和Western Ontario半月板评估工具（WOMET）评分的变化（每个评分范围从0到100，分数越低表示症状越严重）和运动后膝关节疼痛的变化（评分从0到10,0表示没有疼痛）在手术后12个月。
我们在 146 名 35 至 65 岁的患者中进行了一项多中心、随机、双盲、假对照试验，这些患者的膝关节症状符合退行性内侧半月板撕裂，且没有膝骨关节炎。患者被随机分配到关节镜下半月板部分切除术或假手术组。主要结局是Lysholm和Western Ontario半月板评估工具（WOMET）评分的变化（每个评分范围从0到100，分数越低表示症状越严重）和运动后膝关节疼痛的变化（评分从0到10,0表示没有疼痛）在手术后12个月。
Results 结果
In the intention-to-treat analysis, there were no significant between-group differences in the change from baseline to 12 months in any primary outcome. The mean changes (improvements) in the primary outcome measures were as follows: Lysholm score, 21.7 points in the partial-meniscectomy group as compared with 23.3 points in the sham-surgery group (between-group difference, −1.6 points; 95% confidence interval [CI], −7.2 to 4.0); WOMET score, 24.6 and 27.1 points, respectively (between-group difference, −2.5 points; 95% CI, −9.2 to 4.1); and score for knee pain after exercise, 3.1 and 3.3 points, respectively (between-group difference, −0.1; 95% CI, −0.9 to 0.7). There were no significant differences between groups in the number of patients who required subsequent knee surgery (two in the partial-meniscectomy group and five in the sham-surgery group) or serious adverse events (one and zero, respectively).
在意向性治疗分析中，任何主要结局从基线到12个月的变化均无显著组间差异。主要结局指标的平均变化（改善）如下：部分半月板切除术组的Lysholm评分为21.7分，而假手术组为23.3分（组间差异为-1.6分;95%置信区间[CI]，-7.2至4.0）;WOMET评分分别为24.6分和27.1分（组间差异，-2.5分;95%CI，-9.2-4.1）;运动后膝关节疼痛得分分别为 3.1 分和 3.3 分（组间差异，-0.1;95% CI，-0.9-0.7）。在需要后续膝关节手术的患者数量（部分半月板切除术组为2例，假手术组为5例）或严重不良事件（分别为1例和0例）方面，两组之间没有显著差异。
在意向性治疗分析中，任何主要结局从基线到12个月的变化均无显著组间差异。主要结局指标的平均变化（改善）如下：部分半月板切除术组的Lysholm评分为21.7分，而假手术组为23.3分（组间差异为-1.6分;95%置信区间[CI]，-7.2至4.0）;WOMET评分分别为24.6分和27.1分（组间差异，-2.5分;95%CI，-9.2-4.1）;运动后膝关节疼痛得分分别为 3.1 分和 3.3 分（组间差异，-0.1;95% CI，-0.9-0.7）。在需要后续膝关节手术的患者数量（部分半月板切除术组为2例，假手术组为5例）或严重不良事件（分别为1例和0例）方面，两组之间没有显著差异。
Conclusions 结论
In this trial involving patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after arthroscopic partial meniscectomy were no better than those after a sham surgical procedure. (Funded by the Sigrid Juselius Foundation and others; ClinicalTrials.gov number, NCT00549172.)
在这项涉及没有膝骨关节炎但有退行性内侧半月板撕裂症状的患者的试验中，关节镜下半月板部分切除术后的结果并不比假手术后的结果好。（由西格丽德·朱塞利乌斯基金会（Sigrid Juselius Foundation）和其他机构资助;ClinicalTrials.gov 编号，NCT00549172。
在这项涉及没有膝骨关节炎但有退行性内侧半月板撕裂症状的患者的试验中，关节镜下半月板部分切除术后的结果并不比假手术后的结果好。（由西格丽德·朱塞利乌斯基金会（Sigrid Juselius Foundation）和其他机构资助;ClinicalTrials.gov 编号，NCT00549172。
Arthroscopic partial meniscectomy is the most common orthopedic procedure performed in the United States.1 The aim of the procedure is to relieve symptoms attributed to a meniscal tear by removing torn meniscal fragments and trimming the meniscus back to a stable rim. Most treated meniscal tears are associated with degenerative knee disease, which can range from mild chondral changes not visible on a radiograph to established knee osteoarthritis.2,3 The number of arthroscopic surgical procedures performed to treat established knee osteoarthritis, with or without a concomitant meniscal lesion, has decreased dramatically in the past 15 years.4,5 This trend has been attributed to two controlled trials6,7 showing a lack of efficacy of arthroscopic surgery. However, the number of arthroscopic partial meniscectomies performed has concurrently increased by 50%.4 Approximately 700,000 arthroscopic partial meniscectomies are performed annually in the United States alone,1 with annual direct medical costs estimated at $4 billion. A recent randomized trial8 showed that arthroscopic partial meniscectomy combined with physical therapy provides no better relief of symptoms than physical therapy alone in patients with a meniscal tear and knee osteoarthritis. We conducted a multicenter, randomized, double-blind, sham-controlled trial to assess the efficacy of arthroscopic partial meniscectomy in patients who have a degenerative tear of the medial meniscus without knee osteoarthritis.
关节镜下半月板部分切除术是美国最常见的骨科手术。 1 该手术的目的是通过去除撕裂的半月板碎片并将半月板修剪回稳定的边缘来缓解半月板撕裂引起的症状。大多数接受治疗的半月板撕裂都与退行性膝关节疾病有关，其范围从X光片上不可见的轻度软骨变化到已确诊的膝骨关节炎。 2,3 在过去 15 年中，为治疗已确诊的膝骨关节炎而进行的关节镜外科手术数量（伴有或不伴随半月板病变）数量急剧减少。 4,5 这种趋势归因于两项对照试验 6,7 ，显示关节镜手术缺乏疗效。然而，进行关节镜下部分半月板切除术的数量同时增加了 50%。 4 仅在美国，每年就进行约 700,000 例关节镜下半月板部分切除术， 1 每年的直接医疗费用估计为 40 亿美元。最近的一项随机试验 8 表明，对于半月板撕裂和膝骨关节炎患者，关节镜下半月板部分切除术联合物理治疗并不能比单独物理治疗更好地缓解症状。我们进行了一项多中心、随机、双盲、假对照试验，以评估关节镜下半月板部分切除术对无膝骨关节炎的内侧半月板退行性撕裂患者的疗效。
关节镜下半月板部分切除术是美国最常见的骨科手术。 1 该手术的目的是通过去除撕裂的半月板碎片并将半月板修剪回稳定的边缘来缓解半月板撕裂引起的症状。大多数接受治疗的半月板撕裂都与退行性膝关节疾病有关，其范围从X光片上不可见的轻度软骨变化到已确诊的膝骨关节炎。 2,3 在过去 15 年中，为治疗已确诊的膝骨关节炎而进行的关节镜外科手术数量（伴有或不伴随半月板病变）数量急剧减少。 4,5 这种趋势归因于两项对照试验 6,7 ，显示关节镜手术缺乏疗效。然而，进行关节镜下部分半月板切除术的数量同时增加了 50%。 4 仅在美国，每年就进行约 700,000 例关节镜下半月板部分切除术， 1 每年的直接医疗费用估计为 40 亿美元。最近的一项随机试验 8 表明，对于半月板撕裂和膝骨关节炎患者，关节镜下半月板部分切除术联合物理治疗并不能比单独物理治疗更好地缓解症状。我们进行了一项多中心、随机、双盲、假对照试验，以评估关节镜下半月板部分切除术对无膝骨关节炎的内侧半月板退行性撕裂患者的疗效。
Methods 方法
Trial Design 试验设计
We conducted this parallel-group study at five orthopedic clinics in Finland during the period from December 2007 through January 2013. Details of the trial design and methods have been published elsewhere.9 The patients, the people who collected and analyzed the data, and the authors were unaware of the study-group assignments. The protocol was approved by the institutional review board of the Pirkanmaa Hospital District. The first and last authors vouch for the accuracy and completeness of the reported data and analyses and for adherence of the study to the protocol, available with the full text of this article at NEJM.org.
我们在 2007 年 12 月至 2013 年 1 月期间在芬兰的五家骨科诊所进行了这项平行组研究。试验设计和方法的细节已在其他部分发表。 9 患者、收集和分析数据的人以及作者都不知道研究组的分配。该协议得到了 Pirkanmaa 医院区机构审查委员会的批准。第一作者和最后一位作者保证所报告的数据和分析的准确性和完整性，以及该研究对协议的遵守，可在 NEJM.org 查阅本文全文。
我们在 2007 年 12 月至 2013 年 1 月期间在芬兰的五家骨科诊所进行了这项平行组研究。试验设计和方法的细节已在其他部分发表。 9 患者、收集和分析数据的人以及作者都不知道研究组的分配。该协议得到了 Pirkanmaa 医院区机构审查委员会的批准。第一作者和最后一位作者保证所报告的数据和分析的准确性和完整性，以及该研究对协议的遵守，可在 NEJM.org 查阅本文全文。
The study was conducted in accordance with the Declaration of Helsinki. All patients gave written informed consent. On entering the study, patients were unequivocally informed that they might undergo sham surgery and that they would be allowed to consider crossing over to the other procedure (arthroscopic partial meniscectomy) 6 months or later after the sham procedure if they did not have adequate relief of symptoms.
这项研究是根据《赫尔辛基宣言》进行的。所有患者均给予书面知情同意书。在进入研究时，患者被明确告知他们可能会接受假手术，如果他们没有得到充分的症状缓解，他们将被允许考虑在假手术后 6 个月或更晚进行其他手术（关节镜部分半月板切除术）。
这项研究是根据《赫尔辛基宣言》进行的。所有患者均给予书面知情同意书。在进入研究时，患者被明确告知他们可能会接受假手术，如果他们没有得到充分的症状缓解，他们将被允许考虑在假手术后 6 个月或更晚进行其他手术（关节镜部分半月板切除术）。
Participants 参与者
We enrolled patients 35 to 65 years of age who had knee pain (for >3 months) that was unresponsive to conventional conservative treatment and had clinical findings consistent with a tear of the medial meniscus (Figure 1). Patients with an obvious traumatic onset of symptoms or with knee osteoarthritis as defined with the use of clinical criteria (American College of Rheumatology)10 or radiographic criteria (Kellgren–Lawrence grade >1)11 were excluded. On the Kellgren–Lawrence scale, grade 0 denotes no abnormalities, grade 1 minor degenerative changes (doubtful narrowing of the joint space and possible osteophytic lipping), and grade 2 knee osteoarthritis (definite narrowing of the joint line or an osteophyte). Preoperative magnetic resonance imaging (MRI) was performed to confirm the presence of a medial meniscus tear, but the eligibility of the patients was ultimately determined by arthroscopic examination. Detailed inclusion and exclusion criteria are provided in Table S1 in the Supplementary Appendix, available at NEJM.org.
我们招募了 35 至 65 岁的患者，他们的膝关节疼痛（>3 个月）对常规保守治疗无反应，临床表现与内侧半月板撕裂一致（图 1）。具有明显创伤性症状发作的患者或使用临床标准（美国风湿病学会） 10 或放射学标准（Kellgren-Lawrence >1 级） 11 定义的膝骨关节炎患者被排除在外。在 Kellgren-Lawrence 量表上，0 级表示无异常，1 级表示轻微退行性改变（关节间隙可疑变窄和可能的骨赘唇裂）和 2 级膝骨关节炎（关节线或骨赘明确变窄）。术前进行了磁共振成像 （MRI） 以确认内侧半月板撕裂的存在，但患者的资格最终通过关节镜检查确定。详细的纳入和排除标准在补充附录的表 S1 中提供，可在 NEJM.org 上查阅。
我们招募了 35 至 65 岁的患者，他们的膝关节疼痛（>3 个月）对常规保守治疗无反应，临床表现与内侧半月板撕裂一致（图 1）。具有明显创伤性症状发作的患者或使用临床标准（美国风湿病学会） 10 或放射学标准（Kellgren-Lawrence >1 级） 11 定义的膝骨关节炎患者被排除在外。在 Kellgren-Lawrence 量表上，0 级表示无异常，1 级表示轻微退行性改变（关节间隙可疑变窄和可能的骨赘唇裂）和 2 级膝骨关节炎（关节线或骨赘明确变窄）。术前进行了磁共振成像 （MRI） 以确认内侧半月板撕裂的存在，但患者的资格最终通过关节镜检查确定。详细的纳入和排除标准在补充附录的表 S1 中提供，可在 NEJM.org 上查阅。
Figure 1 图1
患者入组和随机分组。
Diagnostic Arthroscopy 诊断性关节镜检查
Arthroscopic examination of the knee was first performed in all patients with the use of standard anterolateral and anteromedial portals and a 4-mm arthroscope. The orthopedic surgeon evaluated the medial, lateral, and patellofemoral joint compartments and graded the intraarticular pathologic changes (Table S2 in the Supplementary Appendix).12,13
首先对所有患者进行膝关节镜检查，使用标准的前外侧和前内侧门静脉以及 4 毫米关节镜。骨科医生评估了内侧、外侧和髌股关节室，并对关节内病理变化进行了分级（补充附录中的表 S2）。 12,13
首先对所有患者进行膝关节镜检查，使用标准的前外侧和前内侧门静脉以及 4 毫米关节镜。骨科医生评估了内侧、外侧和髌股关节室，并对关节内病理变化进行了分级（补充附录中的表 S2）。 12,13
Randomization 随机化
During the diagnostic arthroscopic procedure, if a patient was confirmed to be eligible for the trial, the surgeon asked a research nurse to open an envelope containing the study-group assignment (arthroscopic partial meniscectomy or sham surgery) and reveal it to the surgeon; the assignment was not revealed to the patient. The sequentially numbered, opaque, sealed envelopes were prepared by a statistician with no involvement in the clinical care of patients in the trial. Randomization was performed in a 1:1 ratio with a block size of 4 (known only to the statistician). The randomization sequence involved stratification according to study site, age (35 to 50 or 51 to 65 years of age), sex, and the absence or presence of minor degenerative changes on a radiograph (Kellgren–Lawrence grade 0 or 1, respectively).11 Only the orthopedic surgeon and other staff in the operating room were made aware of the group assignment, and they did not participate in further treatment or follow-up of the patient.
在诊断性关节镜手术过程中，如果确认患者符合试验条件，外科医生要求研究护士打开一个包含研究组任务（关节镜部分半月板切除术或假手术）的信封并将其展示给外科医生;该任务没有向患者透露。按顺序编号的、不透明的、密封的信封是由统计学家准备的，没有参与试验中患者的临床护理。随机化以 1：1 的比例进行，块大小为 4（只有统计学家知道）。随机化顺序包括根据研究地点、年龄（35 至 50 岁或 51 至 65 岁）、性别以及 X 光片上是否存在轻微退行性变化（分别为 Kellgren-Lawrence 0 级或 1 级）进行分层。 11 只有整形外科医生和手术室的其他工作人员知道小组分配，他们没有参与患者的进一步治疗或随访。
在诊断性关节镜手术过程中，如果确认患者符合试验条件，外科医生要求研究护士打开一个包含研究组任务（关节镜部分半月板切除术或假手术）的信封并将其展示给外科医生;该任务没有向患者透露。按顺序编号的、不透明的、密封的信封是由统计学家准备的，没有参与试验中患者的临床护理。随机化以 1：1 的比例进行，块大小为 4（只有统计学家知道）。随机化顺序包括根据研究地点、年龄（35 至 50 岁或 51 至 65 岁）、性别以及 X 光片上是否存在轻微退行性变化（分别为 Kellgren-Lawrence 0 级或 1 级）进行分层。 11 只有整形外科医生和手术室的其他工作人员知道小组分配，他们没有参与患者的进一步治疗或随访。
Operative and Postoperative Procedures
手术和术后程序
During the arthroscopic partial meniscectomy, the damaged and loose parts of the meniscus were removed with the use of arthroscopic instruments (a mechanized shaver and meniscal punches) until solid meniscal tissue was reached. The meniscus was then probed to ensure that all loose and weak fragments and unstable meniscus had been successfully resected, with preservation of as much of the meniscus as possible. No other surgical procedure was performed.
在关节镜下半月板部分切除术中，使用关节镜器械（机械化剃须刀和半月板打孔器）切除半月板的受损和松动部分，直到到达坚实的半月板组织。然后探查半月板，以确保所有松散和薄弱的碎片以及不稳定的半月板都被成功切除，并尽可能多地保留半月板。没有进行其他外科手术。
在关节镜下半月板部分切除术中，使用关节镜器械（机械化剃须刀和半月板打孔器）切除半月板的受损和松动部分，直到到达坚实的半月板组织。然后探查半月板，以确保所有松散和薄弱的碎片以及不稳定的半月板都被成功切除，并尽可能多地保留半月板。没有进行其他外科手术。
For the sham surgery, a standard arthroscopic partial meniscectomy was simulated. To mimic the sensations and sounds of a true arthroscopic partial meniscectomy, the surgeon asked for all instruments, manipulated the knee as if an arthroscopic partial meniscectomy was being performed, pushed a mechanized shaver (without the blade) firmly against the patella (outside the knee), and used suction. The patient was also kept in the operating room for the amount of time required to perform an actual arthroscopic partial meniscectomy.
对于假手术，模拟了标准的关节镜下半月板部分切除术。为了模仿真正的关节镜下半月板部分切除术的感觉和声音，外科医生要求使用所有器械，像进行关节镜下半月板部分切除术一样操纵膝盖，将机械化剃须刀（不带刀片）牢牢地推到髌骨（膝盖外侧）上，并使用抽吸。患者还被留在手术室进行实际关节镜下半月板部分切除术所需的时间。
对于假手术，模拟了标准的关节镜下半月板部分切除术。为了模仿真正的关节镜下半月板部分切除术的感觉和声音，外科医生要求使用所有器械，像进行关节镜下半月板部分切除术一样操纵膝盖，将机械化剃须刀（不带刀片）牢牢地推到髌骨（膝盖外侧）上，并使用抽吸。患者还被留在手术室进行实际关节镜下半月板部分切除术所需的时间。
No medication was instilled into the knee during arthroscopy. All procedures were standardized and recorded on video. In both the partial-meniscectomy group and the sham-surgery group, postoperative care was delivered according to a standardized protocol specifying that all patients receive the same walking aids and instructions for the same graduated exercise program (Fig. S1 in the Supplementary Appendix). Patients were instructed to take over-the-counter analgesic agents as required.
在关节镜检查期间，没有将药物滴入膝关节。所有程序均已标准化并记录在视频中。在部分半月板切除术组和假手术组中，术后护理均根据标准化方案进行，该方案规定所有患者接受相同的步行辅助设备和相同渐进式锻炼计划的指导（补充附录中的图 S1）。指示患者根据需要服用非处方镇痛药。
在关节镜检查期间，没有将药物滴入膝关节。所有程序均已标准化并记录在视频中。在部分半月板切除术组和假手术组中，术后护理均根据标准化方案进行，该方案规定所有患者接受相同的步行辅助设备和相同渐进式锻炼计划的指导（补充附录中的图 S1）。指示患者根据需要服用非处方镇痛药。
Outcome Measures 结果测量
Initially, our two primary outcomes were knee pain after exercise (during the preceding week) and the Lysholm knee score at 12 months after surgery. Knee pain was assessed on an 11-point scale ranging from 0 (no pain) to 10 (extreme pain). The Lysholm knee score is a validated,14 condition-specific outcome measure.15 After the Western Ontario Meniscal Evaluation Tool (WOMET),16 a meniscus-specific health-related quality-of-life instrument, was validated for patients with a degenerative meniscal tear,17 this measure was added as our third primary outcome (before any data analysis). The Lysholm and WOMET scores each range from 0 to 100, with 0 indicating the most severe symptoms and 100 an absence of symptoms. Secondary outcomes included the score for knee pain after exercise and the Lysholm and WOMET score measured at 2 and 6 months after surgery; knee pain at rest, measured at 12 months; and the score on 15D, a generic health-related quality-of-life instrument made up of 15 dimensions and scored on a scale of 0 (death) to 1 (full health), also measured at 12 months.18
最初，我们的两个主要结果是运动后（前一周）的膝关节疼痛和手术后 12 个月的 Lysholm 膝关节评分。膝关节疼痛以 11 分制评估，范围从 0（无疼痛）到 10（极度疼痛）。Lysholm 膝关节评分是一种经过验证的、 14 针对特定条件的结果测量。 15 在西安大略省半月板评估工具 （WOMET）（ 16 一种针对半月板的健康相关生活质量工具）对退行性半月板撕裂患者进行验证后， 17 该指标被添加为我们的第三个主要结果（在任何数据分析之前）。Lysholm 和 WOMET 评分范围均为 0 到 100，其中 0 表示症状最严重，100 表示没有症状。次要结局包括运动后膝关节疼痛评分以及术后2个月和6个月测量的Lysholm和WOMET评分;休息时膝关节疼痛，在 12 个月时测量;以及 15D 的分数，这是一种与健康相关的通用生活质量工具，由 15 个维度组成，评分范围为 0（死亡）到 1（完全健康），也在 12 个月时测量。 18
最初，我们的两个主要结果是运动后（前一周）的膝关节疼痛和手术后 12 个月的 Lysholm 膝关节评分。膝关节疼痛以 11 分制评估，范围从 0（无疼痛）到 10（极度疼痛）。Lysholm 膝关节评分是一种经过验证的、 14 针对特定条件的结果测量。 15 在西安大略省半月板评估工具 （WOMET）（ 16 一种针对半月板的健康相关生活质量工具）对退行性半月板撕裂患者进行验证后， 17 该指标被添加为我们的第三个主要结果（在任何数据分析之前）。Lysholm 和 WOMET 评分范围均为 0 到 100，其中 0 表示症状最严重，100 表示没有症状。次要结局包括运动后膝关节疼痛评分以及术后2个月和6个月测量的Lysholm和WOMET评分;休息时膝关节疼痛，在 12 个月时测量;以及 15D 的分数，这是一种与健康相关的通用生活质量工具，由 15 个维度组成，评分范围为 0（死亡）到 1（完全健康），也在 12 个月时测量。 18
Questionnaires were administered at baseline and at 2, 6, and 12 months after surgery. The follow-up questionnaires included a separate section on adverse events, defined as untoward medical occurrences that may or may not have had a causal relationship with the treatment administered. Adverse events were classified as serious if they necessitated hospitalization or prolonged inpatient hospital care, or if they were life-threatening or resulted in death. For the 12-month follow-up questionnaire, the patients also responded to the following four questions: Is your knee better than before the intervention? Are you satisfied with your knee at present? Would you choose to be operated on again if you were asked to make the decision now? Which procedure do you think you underwent? Responses to the first two questions were given on a 5-point Likert scale; the response to the third question was “yes” or “no.”
问卷调查在基线和手术后 2、6 和 12 个月进行。后续问卷包括一个关于不良事件的单独部分，不良事件被定义为可能与所接受的治疗有或没有因果关系的不良医疗事件。如果不良事件需要住院治疗或长期住院治疗，或者如果它们危及生命或导致死亡，则不良事件被归类为严重事件。对于为期 12 个月的随访问卷，患者还回答了以下四个问题：您的膝盖是否比干预前更好？你现在对你的膝盖满意吗？如果您现在被要求做出决定，您会选择再次接受手术吗？您认为您接受了哪种手术？对前两个问题的回答采用 5 分李克特量表;对第三个问题的回答是“是”或“否”。
问卷调查在基线和手术后 2、6 和 12 个月进行。后续问卷包括一个关于不良事件的单独部分，不良事件被定义为可能与所接受的治疗有或没有因果关系的不良医疗事件。如果不良事件需要住院治疗或长期住院治疗，或者如果它们危及生命或导致死亡，则不良事件被归类为严重事件。对于为期 12 个月的随访问卷，患者还回答了以下四个问题：您的膝盖是否比干预前更好？你现在对你的膝盖满意吗？如果您现在被要求做出决定，您会选择再次接受手术吗？您认为您接受了哪种手术？对前两个问题的回答采用 5 分李克特量表;对第三个问题的回答是“是”或“否”。
Statistical Analysis 统计分析
We powered the study to detect a minimal clinically important improvement in the Lysholm and WOMET scores (improvements of at least 11.5 and 15.5 points, respectively) and in the score for knee pain after exercise (improvement of at least 2.0 points) between the partial-meniscectomy and sham-surgery groups.9 The estimates of minimal clinically important improvement were based on the difference we noted in our prospective cohort of 377 patients with a degenerative meniscal injury who had undergone arthroscopic partial meniscectomy.9 For the study to have 80% power to show a clinically meaningful advantage of arthroscopic partial meniscectomy over sham surgery, under the assumption of a two-sided type 1 error rate of 5%, the required sample sizes were 40, 54, and 40 participants per group for the Lysholm score, the WOMET score, and the score for knee pain after exercise, respectively. Anticipating a loss to follow-up of at least 20%, we planned to recruit 70 patients per group.
我们为该研究提供动力，以检测部分半月板切除术组和假手术组之间的 Lysholm 和 WOMET 评分（分别至少提高 11.5 分和 15.5 分）以及运动后膝关节疼痛评分（至少改善 2.0 分）的临床重要改善微小。 9 对最小临床重要改善的估计是基于我们在377例接受关节镜下半月板部分切除术的退行性半月板损伤患者的前瞻性队列中注意到的差异。 9 为了使该研究有 80% 的功效显示关节镜下半月板部分切除术相对于假手术具有临床意义的优势，在双侧 1 型错误率为 5% 的假设下，所需的样本量为 40、54 和 40 名参与者每组 Lysholm 评分、WOMET 评分和运动后膝关节疼痛评分， 分别。预计随访损失至少为 20%，我们计划每组招募 70 名患者。
我们为该研究提供动力，以检测部分半月板切除术组和假手术组之间的 Lysholm 和 WOMET 评分（分别至少提高 11.5 分和 15.5 分）以及运动后膝关节疼痛评分（至少改善 2.0 分）的临床重要改善微小。 9 对最小临床重要改善的估计是基于我们在377例接受关节镜下半月板部分切除术的退行性半月板损伤患者的前瞻性队列中注意到的差异。 9 为了使该研究有 80% 的功效显示关节镜下半月板部分切除术相对于假手术具有临床意义的优势，在双侧 1 型错误率为 5% 的假设下，所需的样本量为 40、54 和 40 名参与者每组 Lysholm 评分、WOMET 评分和运动后膝关节疼痛评分， 分别。预计随访损失至少为 20%，我们计划每组招募 70 名患者。
The trial was designed to ascertain whether arthroscopic partial meniscectomy is superior to sham surgery, at 12 months after the procedure, with regard to the three primary outcomes. Baseline characteristics were analyzed with the use of descriptive statistics. For the primary analysis, the change in each score (mean and 95% confidence interval) from baseline to 12 months was compared between the two study groups. This analysis was also performed after adjustment for the baseline score and for the stratifying variables used for randomization. Secondary analyses included between-group comparisons of the change in the 15D score and in the score for knee pain at rest, as well as comparisons of the frequencies of patients who reported satisfaction or subjective improvement, who had serious adverse events, or whose treatment assignment was revealed within 12 months after surgery (who required subsequent knee surgery). Analyses of the primary outcomes were also performed at 2 and 6 months, but these analyses were intended only to illustrate the trajectory of the treatment response.
该试验旨在确定关节镜下部分半月板切除术在手术后12个月的三个主要结局方面是否优于假手术。使用描述性统计分析基线特征。对于主要分析，比较了两个研究组之间从基线到 12 个月的每个分数（平均和 95% 置信区间）的变化。该分析也是在调整基线分数和用于随机化的分层变量后进行的。次要分析包括15D评分变化的组间比较和静息时膝关节疼痛评分的变化，以及报告满意度或主观改善、有严重不良事件的患者或手术后12个月内揭示治疗分配的患者（需要后续膝关节手术）的频率比较。主要结局的分析也在2个月和6个月时进行，但这些分析仅用于说明治疗反应的轨迹。
该试验旨在确定关节镜下部分半月板切除术在手术后12个月的三个主要结局方面是否优于假手术。使用描述性统计分析基线特征。对于主要分析，比较了两个研究组之间从基线到 12 个月的每个分数（平均和 95% 置信区间）的变化。该分析也是在调整基线分数和用于随机化的分层变量后进行的。次要分析包括15D评分变化的组间比较和静息时膝关节疼痛评分的变化，以及报告满意度或主观改善、有严重不良事件的患者或手术后12个月内揭示治疗分配的患者（需要后续膝关节手术）的频率比较。主要结局的分析也在2个月和6个月时进行，但这些分析仅用于说明治疗反应的轨迹。
Because knee osteoarthritis has been associated with poor outcomes after knee arthroscopy,19 our only prespecified subgroup analysis was performed with patients stratified according to the extent of radiographically assessed degenerative changes (Kellgren–Lawrence grade 0 [no degeneration] vs. grade 1 [minor degenerative changes]). A Student's t-test and nonparametric test were used to compare continuous variables (normally distributed and not normally distributed, respectively) between the groups, and Fisher's exact test was used with binomial and categorical variables. Univariate analysis was used to test for interaction in the subgroup analysis. All statistical analyses were performed on an intention-to-treat basis; no per-protocol analysis was performed, because the frequency of crossover was low. A P value of 0.05 was considered to indicate statistical significance. SPSS Statistics, version 20 (IBM), was used for all statistical analyses.
由于膝骨关节炎与膝关节镜检查后的不良结果有关， 19 因此我们唯一预先设定的亚组分析是根据放射学评估的退行性变化的程度对患者进行分层（Kellgren-Lawrence 0 级 [无退行性变性] vs 1 级 [轻微退行性变化]）。采用A学生t检验和非参数检验比较各组间连续变量（分别为正态分布和非正态分布），Fisher精确检验分别用于二项式变量和分类变量。采用单因素分析检验亚组分析中的交互作用。所有统计分析均在意向性治疗的基础上进行;由于交叉频率较低，因此未执行按协议进行的分析。P 值为 0.05 表示统计学意义。SPSS Statistics 版本 20 （IBM） 用于所有统计分析。
由于膝骨关节炎与膝关节镜检查后的不良结果有关， 19 因此我们唯一预先设定的亚组分析是根据放射学评估的退行性变化的程度对患者进行分层（Kellgren-Lawrence 0 级 [无退行性变性] vs 1 级 [轻微退行性变化]）。采用A学生t检验和非参数检验比较各组间连续变量（分别为正态分布和非正态分布），Fisher精确检验分别用于二项式变量和分类变量。采用单因素分析检验亚组分析中的交互作用。所有统计分析均在意向性治疗的基础上进行;由于交叉频率较低，因此未执行按协议进行的分析。P 值为 0.05 表示统计学意义。SPSS Statistics 版本 20 （IBM） 用于所有统计分析。
The writing committee developed and recorded two interpretations of the results on the basis of a blinded review of the primary outcome data (treatment A compared with treatment B), one assuming that treatment A was arthroscopic partial meniscectomy, and the other assuming that treatment A was sham surgery. Only after the committee members had agreed that there would be no further changes in the interpretation was the randomization code broken, the correct interpretation chosen, and the manuscript finalized (see the Supplementary Appendix).20
编写委员会根据对主要结局数据的盲法审查（治疗 A 与治疗 B 的比较）制定并记录了对结果的两种解释，一种假设治疗 A 是关节镜半月板部分切除术，另一种假设治疗 A 是假手术。只有在委员会成员同意不再对解释进行进一步更改后，随机化代码才被打破，正确的解释被选中，手稿才最终确定（见补充附录）。 20
编写委员会根据对主要结局数据的盲法审查（治疗 A 与治疗 B 的比较）制定并记录了对结果的两种解释，一种假设治疗 A 是关节镜半月板部分切除术，另一种假设治疗 A 是假手术。只有在委员会成员同意不再对解释进行进一步更改后，随机化代码才被打破，正确的解释被选中，手稿才最终确定（见补充附录）。 20
Results 结果
Characteristics of the Patients
患者的特征
Of the 205 patients who were eligible for enrollment, 59 were excluded; Figure 1 shows the reasons for exclusion. A total of 146 patients underwent randomization; 70 were assigned to undergo arthroscopic partial meniscectomy, and 76 were assigned to undergo sham surgery. The baseline characteristics of the two groups were similar (Table 1, and Table S2 in the Supplementary Appendix). The patients who declined to participate were similar to those who underwent randomization with respect to age, sex, and body-mass index, and all underwent arthroscopic partial meniscectomy. There was no loss to follow-up.
在符合入组条件的 205 名患者中，有 59 名被排除在外;图 1 显示了排除的原因。共有 146 名患者接受随机分组;70 人被分配接受关节镜下部分半月板切除术，76 人被分配接受假手术。两组的基线特征相似（补充附录表1和表S2）。拒绝参加的患者在年龄、性别和体重指数方面与接受随机分组的患者相似，并且都接受了关节镜下半月板部分切除术。随访没有损失。
在符合入组条件的 205 名患者中，有 59 名被排除在外;图 1 显示了排除的原因。共有 146 名患者接受随机分组;70 人被分配接受关节镜下部分半月板切除术，76 人被分配接受假手术。两组的基线特征相似（补充附录表1和表S2）。拒绝参加的患者在年龄、性别和体重指数方面与接受随机分组的患者相似，并且都接受了关节镜下半月板部分切除术。随访没有损失。
Table 1 表1
根据研究组的患者基线特征。
Primary Outcomes 主要结局
Although marked improvement from baseline to 12 months was seen in the three primary outcomes in both study groups (Figure 2 and Table 2), there were no significant between-group differences in the change from baseline to 12 months in any of these measures. The mean between-group difference in improvement in the Lysholm knee score was −1.6 points (95% confidence interval [CI], −7.2 to 4.0), that in the WOMET score was −2.5 points (95% CI, −9.2 to 4.1), and that in the score for knee pain after exercise was −0.1 points (95% CI, −0.9 to 0.7) (Table 2). These results did not materially change after adjustment for baseline scores and stratifying variables used for randomization (Table S3 in the Supplementary Appendix).
尽管两个研究组的三个主要结局从基线到12个月都有明显的改善（图2和表2），但这些指标中的任何一项从基线到12个月的变化都没有显著的组间差异。Lysholm膝关节评分改善的平均组间差异为-1.6分（95%置信区间[CI]，-7.2至4.0），WOMET评分为-2.5分（95%CI，-9.2至4.1），运动后膝关节疼痛评分为-0.1分（95%CI，-0.9至0.7）（表2）。在调整基线分数和用于随机化的分层变量后，这些结果没有实质性变化（补充附录中的表S3）。
尽管两个研究组的三个主要结局从基线到12个月都有明显的改善（图2和表2），但这些指标中的任何一项从基线到12个月的变化都没有显著的组间差异。Lysholm膝关节评分改善的平均组间差异为-1.6分（95%置信区间[CI]，-7.2至4.0），WOMET评分为-2.5分（95%CI，-9.2至4.1），运动后膝关节疼痛评分为-0.1分（95%CI，-0.9至0.7）（表2）。在调整基线分数和用于随机化的分层变量后，这些结果没有实质性变化（补充附录中的表S3）。
Figure 2 图2
Primary Outcomes in the Partial-Meniscectomy Group and the Sham-Surgery Group.
部分半月板切除术组和假手术组的主要结果。
部分半月板切除术组和假手术组的主要结果。
Lysholm knee scores (Panel A), Western Ontario Meniscal Evaluation Tool (WOMET) scores (Panel B), and scores for knee pain after exercise (Panel C) over the 12-month follow-up period are shown. Lysholm knee scores and WOMET scores range from 0 to 100, with lower scores indicating more severe symptoms; scores for knee pain after exercise range from 0 to 10, with higher scores indicating more severe pain. I bars denote 95% confidence intervals. A single value was missing for one patient in the sham-surgery group at the 6-month follow-up and for one patient in the partial-meniscectomy group at the 12-month follow-up; these values were not imputed.
Table 2 表2
关节镜检查后 12 个月的主要和次要结果。
Secondary and Other Outcomes
次要结局和其他结局
No significant between-group differences were found in any of the secondary outcomes, in the frequency of the need for subsequent knee surgery, or in the frequency of serious adverse events (Table 2, and Table S4 in the Supplementary Appendix). Also, in the prespecified subgroup analysis, no significant between-group differences were found in the primary outcomes at 12 months when the study groups were stratified according to the Kellgren–Lawrence grade, and there were no significant interactions by grade (Table S5 in the Supplementary Appendix). In an additional, post hoc subgroup analysis, we likewise found no significant benefit of arthroscopic partial meniscectomy over sham surgery among patients who reported a sudden onset of symptoms (Table S6 in the Supplementary Appendix).
在任何次要结局、需要后续膝关节手术的频率或严重不良事件的频率方面，均未发现组间显着差异（补充附录中的表2和表S4）。此外，在预先指定的亚组分析中，当研究组根据Kellgren-Lawrence等级进行分层时，在12个月时的主要结局中没有发现显著的组间差异，并且按等级划分没有显着的交互作用（补充附录中的表S5）。在一项额外的事后亚组分析中，我们同样发现，在报告症状突然发作的患者中，关节镜下半月板部分切除术比假手术没有显着益处（补充附录中的表S6）。
在任何次要结局、需要后续膝关节手术的频率或严重不良事件的频率方面，均未发现组间显着差异（补充附录中的表2和表S4）。此外，在预先指定的亚组分析中，当研究组根据Kellgren-Lawrence等级进行分层时，在12个月时的主要结局中没有发现显著的组间差异，并且按等级划分没有显着的交互作用（补充附录中的表S5）。在一项额外的事后亚组分析中，我们同样发现，在报告症状突然发作的患者中，关节镜下半月板部分切除术比假手术没有显着益处（补充附录中的表S6）。
Two patients in the partial-meniscectomy group and five patients in the sham-surgery group reported persistent symptoms after surgery that were sufficiently severe to lead to revealing of the study-group assignment (at an average of 8 months after the index operation) and to consequent additional surgery. Of the two patients who underwent additional knee surgery after arthroscopic partial meniscectomy, one had a total knee replacement 10 months after the index procedure because of MRI-verified aseptic necrosis of the medial femoral condyle, and the other underwent a second resection of the meniscus 5 months after the index procedure because of a recurrence of symptoms.
部分半月板切除术组的 2 名患者和假手术组的 5 名患者报告术后症状持续存在，这些症状严重到足以导致揭示研究组分配（指标手术后平均 8 个月）并导致额外手术。在关节镜下半月板部分切除术后接受额外膝关节手术的两名患者中，一名患者在指标手术后 10 个月进行了全膝关节置换术，原因是 MRI 证实的股内侧髁无菌性坏死，另一名患者在指标手术后 5 个月接受了第二次半月板切除术，因为症状复发。
部分半月板切除术组的 2 名患者和假手术组的 5 名患者报告术后症状持续存在，这些症状严重到足以导致揭示研究组分配（指标手术后平均 8 个月）并导致额外手术。在关节镜下半月板部分切除术后接受额外膝关节手术的两名患者中，一名患者在指标手术后 10 个月进行了全膝关节置换术，原因是 MRI 证实的股内侧髁无菌性坏死，另一名患者在指标手术后 5 个月接受了第二次半月板切除术，因为症状复发。
Patients in the sham-surgery group were not significantly more likely than patients in the partial-meniscectomy group to guess that they had undergone a sham procedure (47% and 38%, respectively; P=0.39).
与部分半月板切除术组患者相比，假手术组患者猜测自己接受过假手术的可能性并不显著（分别为 47% 和 38%;P=0.39）。
与部分半月板切除术组患者相比，假手术组患者猜测自己接受过假手术的可能性并不显著（分别为 47% 和 38%;P=0.39）。
Discussion 讨论
This multicenter, randomized, sham-controlled trial involving patients with a degenerative medial meniscus tear showed that arthroscopic partial meniscectomy was not superior to sham surgery, with regard to outcomes assessed during a 12-month follow-up period. Although both groups had significant improvement in all primary outcomes, the patients assigned to arthroscopic partial meniscectomy had no greater improvement than those assigned to sham surgery.
这项涉及退行性内侧半月板撕裂患者的多中心、随机、假对照试验表明，在 12 个月的随访期间评估的结果方面，关节镜下半月板部分切除术并不优于假手术。尽管两组在所有主要结局上都有显着改善，但分配到关节镜下部分半月板切除术的患者没有比分配到假手术的患者有更大的改善。
这项涉及退行性内侧半月板撕裂患者的多中心、随机、假对照试验表明，在 12 个月的随访期间评估的结果方面，关节镜下半月板部分切除术并不优于假手术。尽管两组在所有主要结局上都有显着改善，但分配到关节镜下部分半月板切除术的患者没有比分配到假手术的患者有更大的改善。
We are aware of one previous randomized, sham-controlled trial of arthroscopic treatment for degenerative knee disease.6 In patients with established knee osteoarthritis, arthroscopic lavage or débridement did not result in better outcomes than a sham procedure (skin incisions only). In a subsequent trial that did not involve a sham control, arthroscopic surgery coupled with optimized physical and medical therapy showed no significant benefit over optimized physical and medical therapy alone.7 In previous trials assessing the benefit of arthroscopic partial meniscectomy in the treatment of a degenerative meniscal tear in patients with varying degrees of knee osteoarthritis,8,21,22 arthroscopic surgery and exercise therapy were not superior to exercise therapy alone.
我们知道之前有一项关于关节镜治疗退行性膝关节疾病的随机、假对照试验。 6 在确诊膝骨关节炎的患者中，关节镜灌洗或清创术并没有比假手术（仅皮肤切口）产生更好的结果。在随后的一项不涉及假对照的试验中，关节镜手术与优化的物理和药物治疗相比，与单独的优化物理和药物治疗相比没有显着益处。 7 在先前评估关节镜部分半月板切除术治疗不同程度膝骨关节炎患者退行性半月板撕裂的益处的试验中， 8,21,22 关节镜手术和运动疗法并不优于单独的运动疗法。
我们知道之前有一项关于关节镜治疗退行性膝关节疾病的随机、假对照试验。 6 在确诊膝骨关节炎的患者中，关节镜灌洗或清创术并没有比假手术（仅皮肤切口）产生更好的结果。在随后的一项不涉及假对照的试验中，关节镜手术与优化的物理和药物治疗相比，与单独的优化物理和药物治疗相比没有显着益处。 7 在先前评估关节镜部分半月板切除术治疗不同程度膝骨关节炎患者退行性半月板撕裂的益处的试验中， 8,21,22 关节镜手术和运动疗法并不优于单独的运动疗法。
Whereas these earlier trials assessed whether arthroscopic surgery confers a benefit in ordinary health care settings (i.e., they were effectiveness trials involving patients with typical degenerative knee disease and varying degrees of knee osteoarthritis),6–8,21,22 we assessed whether arthroscopic partial meniscectomy is effective under “ideal” circumstances.9,23 Accordingly, we selected patients who would be expected to benefit from arthroscopic partial meniscectomy — those with a degenerative tear of the medial meniscus24,25 and no osteoarthritis19 — and the surgeons performing the operations were highly experienced. The use of a sham-surgery control, with study-group assignments concealed from patients as well as from those collecting data and analyzing outcomes, further increased the rigor of our trial. Because the act of performing surgery itself has a profound placebo effect,6,26,27 a true treatment effect is impossible to distinguish from nonspecific (placebo) effects without a sham comparison group.28 Such bias is a particular concern in trials with subjective end points.29 The proportion of patients who guessed that they had undergone a sham procedure was similar in the two groups, which indicates that the study-group assignments were concealed effectively and probably also contributed to the low treatment conversion rate (7% [5 of 76 patients]) in the sham-surgery group.
虽然这些早期的试验评估了关节镜手术在普通医疗保健环境中是否有益（即，它们是涉及患有典型退行性膝关节疾病和不同程度膝骨关节炎的患者的有效性试验）， 6–8,21,22 但我们评估了关节镜下半月板部分切除术在“理想”情况下是否有效。 9,23 因此，我们选择了有望从关节镜下半月板部分切除术中受益的患者——那些内侧半月板退行性撕裂 24,25 且没有骨关节炎的患者 19 ——并且进行手术的外科医生经验丰富。使用假手术对照，对患者以及收集数据和分析结果的人隐瞒研究组分配，进一步提高了我们试验的严谨性。由于进行手术的行为本身具有深刻的安慰剂效应，因此 6,26,27 如果没有假对照组，就无法将真正的治疗效果与非特异性（安慰剂）效应区分开来。 28 在具有主观终点的试验中，这种偏倚是一个特别值得关注的问题。 29 在两组中，猜测自己接受过假手术的患者比例相似，这表明研究组的分配被有效地隐藏了，并且可能也导致了假手术组的低治疗转化率（7% [76 名患者中的 5 名]）。
虽然这些早期的试验评估了关节镜手术在普通医疗保健环境中是否有益（即，它们是涉及患有典型退行性膝关节疾病和不同程度膝骨关节炎的患者的有效性试验）， 6–8,21,22 但我们评估了关节镜下半月板部分切除术在“理想”情况下是否有效。 9,23 因此，我们选择了有望从关节镜下半月板部分切除术中受益的患者——那些内侧半月板退行性撕裂 24,25 且没有骨关节炎的患者 19 ——并且进行手术的外科医生经验丰富。使用假手术对照，对患者以及收集数据和分析结果的人隐瞒研究组分配，进一步提高了我们试验的严谨性。由于进行手术的行为本身具有深刻的安慰剂效应，因此 6,26,27 如果没有假对照组，就无法将真正的治疗效果与非特异性（安慰剂）效应区分开来。 28 在具有主观终点的试验中，这种偏倚是一个特别值得关注的问题。 29 在两组中，猜测自己接受过假手术的患者比例相似，这表明研究组的分配被有效地隐藏了，并且可能也导致了假手术组的低治疗转化率（7% [76 名患者中的 5 名]）。
Some limitations of our trial warrant discussion. Our results are directly applicable only to patients with nontraumatic degenerative medial meniscus tears, because a traumatic onset of the condition was an exclusion criterion. However, results of a post hoc subgroup analysis limited to patients who had a sudden onset of symptoms likewise showed no significant benefit of arthroscopic partial meniscectomy over sham surgery, although the sample for this analysis was small. It is possible that some enrolled patients had knee osteoarthritis that was not apparent with the use of the clinical10 and radiological11 criteria we used for diagnosis, but our approach to diagnosing osteoarthritis was consistent with earlier controlled trials6,7 and with clinical practice. The observed 95% confidence intervals around the between-group differences indicate that a clinically significant benefit of arthroscopic partial meniscectomy was unlikely.
我们试验的一些局限性值得讨论。我们的研究结果仅直接适用于非创伤性退行性内侧半月板撕裂的患者，因为该病症的创伤性发作是排除标准。然而，一项仅限于突然出现症状的患者的事后亚组分析结果同样显示，关节镜下半月板部分切除术与假手术相比没有显着益处，尽管该分析的样本很小。一些入组患者可能患有膝骨关节炎，这在使用我们用于诊断的临床 10 和放射学 11 标准时并不明显，但我们诊断骨关节炎的方法与早期的对照试验 6,7 和临床实践一致。观察到的组间差异周围的 95% 置信区间表明，关节镜下半月板部分切除术不太可能有临床显着的益处。
我们试验的一些局限性值得讨论。我们的研究结果仅直接适用于非创伤性退行性内侧半月板撕裂的患者，因为该病症的创伤性发作是排除标准。然而，一项仅限于突然出现症状的患者的事后亚组分析结果同样显示，关节镜下半月板部分切除术与假手术相比没有显着益处，尽管该分析的样本很小。一些入组患者可能患有膝骨关节炎，这在使用我们用于诊断的临床 10 和放射学 11 标准时并不明显，但我们诊断骨关节炎的方法与早期的对照试验 6,7 和临床实践一致。观察到的组间差异周围的 95% 置信区间表明，关节镜下半月板部分切除术不太可能有临床显着的益处。
The patients enrolled in our trial reported medial-joint-line symptoms that are commonly attributed to a meniscal tear. Arthroscopic partial meniscectomy is typically advocated for patients with these symptoms in whom a tear is confirmed by MRI, particularly those without concomitant knee osteoarthritis.30 However, increasing evidence suggests that a degenerative meniscal tear may be an early sign of knee osteoarthritis rather than a separate clinical problem requiring meniscal intervention.2,31–33 For example, one study showed no significant association between the presence of meniscal damage and the development of frequent knee pain in middle-aged and older adults, once the co-occurrence of osteoarthritis at baseline was taken into account.34
参加我们试验的患者报告了内侧关节线症状，这些症状通常归因于半月板撕裂。关节镜下半月板部分切除术通常适用于有这些症状且 MRI 证实撕裂的患者，尤其是没有合并膝骨关节炎的患者。 30 然而，越来越多的证据表明，退行性半月板撕裂可能是膝骨关节炎的早期征兆，而不是需要半月板干预的单独临床问题。 2,31–33 例如，一项研究表明，一旦考虑到基线时骨关节炎的共同发生，半月板损伤的存在与中老年人频繁膝关节疼痛的发展之间没有显着关联。 34
参加我们试验的患者报告了内侧关节线症状，这些症状通常归因于半月板撕裂。关节镜下半月板部分切除术通常适用于有这些症状且 MRI 证实撕裂的患者，尤其是没有合并膝骨关节炎的患者。 30 然而，越来越多的证据表明，退行性半月板撕裂可能是膝骨关节炎的早期征兆，而不是需要半月板干预的单独临床问题。 2,31–33 例如，一项研究表明，一旦考虑到基线时骨关节炎的共同发生，半月板损伤的存在与中老年人频繁膝关节疼痛的发展之间没有显着关联。 34
Previous cohort studies have suggested that progression of osteoarthritis may be more rapid in persons who have undergone arthroscopic partial meniscectomy35,36; it is uncertain whether this is an effect of the surgery.37 Long-term follow-up of patients in the present trial and in other trials8,38 is needed to address this question.
先前的队列研究表明，接受过关节镜下半月板部分切除术 35,36 的人，骨关节炎的进展可能更快;目前尚不确定这是否是手术的影响。 37 在本试验和其他试验 8,38 中，需要对患者进行长期随访来解决这个问题。
先前的队列研究表明，接受过关节镜下半月板部分切除术 35,36 的人，骨关节炎的进展可能更快;目前尚不确定这是否是手术的影响。 37 在本试验和其他试验 8,38 中，需要对患者进行长期随访来解决这个问题。
In conclusion, the results of this randomized, sham-controlled trial show that arthroscopic partial medial meniscectomy provides no significant benefit over sham surgery in patients with a degenerative meniscal tear and no knee osteoarthritis. These results argue against the current practice of performing arthroscopic partial meniscectomy in patients with a degenerative meniscal tear.
总之，这项随机、假对照试验的结果表明，关节镜下部分内侧半月板切除术对退行性半月板撕裂且无膝骨关节炎的患者没有显着的益处。这些结果反对目前在退行性半月板撕裂患者中进行关节镜下半月板部分切除术的做法。
总之，这项随机、假对照试验的结果表明，关节镜下部分内侧半月板切除术对退行性半月板撕裂且无膝骨关节炎的患者没有显着的益处。这些结果反对目前在退行性半月板撕裂患者中进行关节镜下半月板部分切除术的做法。
Notes 笔记
Supported by grants from the Sigrid Juselius Foundation, the Competitive Research Fund of Pirkanmaa Hospital District, and the Academy of Finland.
得到了 Sigrid Juselius 基金会、Pirkanmaa 医院区竞争性研究基金和芬兰学院的资助。
得到了 Sigrid Juselius 基金会、Pirkanmaa 医院区竞争性研究基金和芬兰学院的资助。
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
作者提供的披露表格可与本文全文一起查阅，网址为 NEJM.org。
作者提供的披露表格可与本文全文一起查阅，网址为 NEJM.org。
We thank Heini Huhtala and Seppo Sarna for their help with the statistical analyses; Gordon Guyatt for his help with blinded data interpretation; research coordinator Pirjo Toivonen for her role in the implementation of the trial; research nurses Saara-Maija Hinkkanen, Marja-Liisa Sutinen, Pekka Karppi, Johanna Koivistoinen, and Sari Karesvuori for their assistance; Kari Tikkinen and Ghassan Alami for their critical comments on the manuscript; and Virginia Mattila for linguistic expertise and language revisions.
我们感谢 Heini Huhtala 和 Seppo Sarna 在统计分析方面的帮助;戈登·盖亚特（Gordon Guyatt）在盲法数据解释方面的帮助;研究协调员皮尔霍·托伊沃宁（Pirjo Toivonen）在试验实施中的作用;研究护士 Saara-Maija Hinkkanen、Marja-Liisa Sutinen、Pekka Karppi、Johanna Koivistoinen 和 Sari Karesvuori 的协助;Kari Tikkinen 和 Ghassan Alami 对手稿的批评意见;以及 Virginia Mattila 的语言专业知识和语言修订。
我们感谢 Heini Huhtala 和 Seppo Sarna 在统计分析方面的帮助;戈登·盖亚特（Gordon Guyatt）在盲法数据解释方面的帮助;研究协调员皮尔霍·托伊沃宁（Pirjo Toivonen）在试验实施中的作用;研究护士 Saara-Maija Hinkkanen、Marja-Liisa Sutinen、Pekka Karppi、Johanna Koivistoinen 和 Sari Karesvuori 的协助;Kari Tikkinen 和 Ghassan Alami 对手稿的批评意见;以及 Virginia Mattila 的语言专业知识和语言修订。
Supplementary Material 补充材料
Protocol (nejmoa1305189_protocol.pdf)
协议 （nejmoa1305189_protocol.pdf）
协议 （nejmoa1305189_protocol.pdf）
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Kim, S, Bosque, J, Meehan, JP, Jamali, A, Marder, R. Increase in outpatient knee arthroscopy in the United States: a comparison of National Surveys of Ambulatory Surgery, 1996 and 2006. J Bone Joint Surg Am 2011;93:994-1000
Kim， S， Bosque， J， Meehan， JP， Jamali， A， Marder， R. 美国门诊膝关节镜检查的增加：1996 年和 2006 年全国门诊手术调查的比较。骨关节外科杂志 2011 年;93:994-1000
Kim， S， Bosque， J， Meehan， JP， Jamali， A， Marder， R. 美国门诊膝关节镜检查的增加：1996 年和 2006 年全国门诊手术调查的比较。骨关节外科杂志 2011 年;93:994-1000
5.
Holmes, R, Moschetti, W, Martin, B, Tomek, I, Finlayson, S. Effect of evidence and changes in reimbursement on the rate of arthroscopy for osteoarthritis. Am J Sports Med 2013;41:1039-1043
Holmes， R， Moschetti， W， Martin， B， Tomek， I， Finlayson， S. 证据和报销变化对骨关节炎关节镜检查率的影响。Am J 运动医学 2013;41:1039-1043
Holmes， R， Moschetti， W， Martin， B， Tomek， I， Finlayson， S. 证据和报销变化对骨关节炎关节镜检查率的影响。Am J 运动医学 2013;41:1039-1043
6.
Moseley, JB, O'Malley, K, Petersen, NJ, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 2002;347:81-88
7.
Kirkley, A, Birmingham, TB, Litchfield, RB, et al. A randomized trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 2008;359:1097-1107[Erratum, N Engl J Med 2009;361:2004.]
8.
Katz, JN, Brophy, RH, Chaisson, CE, et al. Surgery versus physical therapy for a meniscal tear and osteoarthritis. N Engl J Med 2013;368:1675-1684
9.
Sihvonen, R, Paavola, M, Malmivaara, A, Jarvinen, TL. Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of arthroscopic partial meniscectomy for patients with degenerative meniscus injury with a novel `RCT within-a-cohort' study design. BMJ Open 2013;3:e002510-e002510
10.
Altman, R, Asch, E, Bloch, D, et al. Development of criteria for the classification and reporting of osteoarthritis: classification of osteoarthritis of the knee. Arthritis Rheum 1986;29:1039-1049
11.
Kellgren, JH, Lawrence, JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis 1957;16:494-502
12.
Brittberg, M, Winalski, CS. Evaluation of cartilage injuries and repair. J Bone Joint Surg Am 2003;85:Suppl 2:58-69
13.
Cooper, DE, Arnoczky, SP, Warren, RF. Meniscal repair. Clin Sports Med 1991;10:529-548
14.
Briggs, KK, Kocher, MS, Rodkey, WG, Steadman, JR. Reliability, validity, and responsiveness of the Lysholm knee score and Tegner activity scale for patients with meniscal injury of the knee. J Bone Joint Surg Am 2006;88:698-705
15.
Tegner, Y, Lysholm, J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res 1985;198:43-49
16.
Kirkley, A, Griffin, S, Whelan, D. The development and validation of a quality of life-measurement tool for patients with meniscal pathology: the Western Ontario Meniscal Evaluation Tool (WOMET). Clin J Sport Med 2007;17:349-356
17.
Sihvonen, R, Jarvela, T, Aho, H, Jarvinen, TL. Validation of the Western Ontario Meniscal Evaluation Tool (WOMET) for patients with a degenerative meniscal tear: a meniscal pathology-specific quality-of-life index. J Bone Joint Surg Am 2012;94:e65-e65
18.
Sintonen, H. The 15D instrument of health-related quality of life: properties and applications. Ann Med 2001;33:328-336
19.
Fabricant, PD, Rosenberger, PH, Jokl, P, Ickovics, JR. Predictors of short-term recovery differ from those of long-term outcome after arthroscopic partial meniscectomy. Arthroscopy 2008;24:769-778
20.
Järvinen TLN, Sihvonen R, Bhandari M, et al. Blinded interpretation of study results can feasibly and effectively diminish interpretation bias. J Clin Epidemiol (in press).
21.
Herrlin, SV, Wange, PO, Lapidus, G, Hallander, M, Werner, S, Weidenhielm, L. Is arthroscopic surgery beneficial in treating non-traumatic, degenerative medial meniscal tears? A five year follow-up. Knee Surg Sports Traumatol Arthrosc 2013;21:358-364
22.
Yim, JH, Seon, JK, Song, EK, et al. A comparative study of meniscectomy and nonoperative treatment for degenerative horizontal tears of the medial meniscus. Am J Sports Med 2013;41:1565-1570
23.
Haynes, B. Can it work? Does it work? Is it worth it? The testing of healthcare interventions is evolving. BMJ 1999;319:652-653
24.
Hede, A, Larsen, E, Sandberg, H. Partial versus total meniscectomy: a prospective, randomised study with long-term follow-up. J Bone Joint Surg Br 1992;74:118-121
25.
Chatain, F, Adeleine, P, Chambat, P, Neyret, P. A comparative study of medial versus lateral arthroscopic partial meniscectomy on stable knees: 10-year minimum follow-up. Arthroscopy 2003;19:842-849
26.
Buchbinder, R, Osborne, RH, Ebeling, PR, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med 2009;361:557-568
27.
Kallmes, DF, Comstock, BA, Heagerty, PJ, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med 2009;361:569-579[Erratum, N Engl J Med 2012;366:970,]
28.
Buchbinder, R. Meniscectomy in patients with knee osteoarthritis and a meniscal tear? N Engl J Med 2013;368:1740-1741
29.
Finniss, DG, Kaptchuk, TJ, Miller, F, Benedetti, F. Biological, clinical, and ethical advances of placebo effects. Lancet 2010;375:686-695
30.
Lyman S, Oh LS, Reinhardt KR, et al. Surgical decision making for arthroscopic partial meniscectomy in patients aged over 40 years. Arthroscopy 2012;28(4):492.e1-501.e1.
31.
Bhattacharyya, T, Gale, D, Dewire, P, et al. The clinical importance of meniscal tears demonstrated by magnetic resonance imaging in osteoarthritis of the knee. J Bone Joint Surg Am 2003;85:4-9
32.
Ding, C, Martel-Pelletier, J, Pelletier, JP, et al. Meniscal tear as an osteoarthritis risk factor in a largely non-osteoarthritic cohort: a cross-sectional study. J Rheumatol 2007;34:776-784
33.
Englund, M, Guermazi, A, Roemer, FW, et al. Meniscal tear in knees without surgery and the development of radiographic osteoarthritis among middle-aged and elderly persons: the Multicenter Osteoarthritis Study. Arthritis Rheum 2009;60:831-839
34.
Englund, M, Niu, J, Guermazi, A, et al. Effect of meniscal damage on the development of frequent knee pain, aching, or stiffness. Arthritis Rheum 2007;56:4048-4054
35.
Roos, EM, Ostenberg, A, Roos, H, Ekdahl, C, Lohmander, LS. Long-term outcome of meniscectomy: symptoms, function, and performance tests in patients with or without radiographic osteoarthritis compared to matched controls. Osteoarthritis Cartilage 2001;9:316-324
36.
Englund, M, Lohmander, LS. Risk factors for symptomatic knee osteoarthritis fifteen to twenty-two years after meniscectomy. Arthritis Rheum 2004;50:2811-2819
37.
Katz, JN, Martin, SD. Meniscus -- friend or foe: epidemiologic observations and surgical implications. Arthritis Rheum 2009;60:633-635
38.
Hare, KB, Lohmander, LS, Christensen, R, Roos, EM. Arthroscopic partial meniscectomy in middle-aged patients with mild or no knee osteoarthritis: a protocol for a double-blind, randomized sham-controlled multi-centre trial. BMC Musculoskelet Disord 2013;14:71-71
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Copyright © 2013 Massachusetts Medical Society. All rights reserved.
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Published online: December 26, 2013
Published in issue: December 26, 2013
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From the Department of Orthopedics and Traumatology, Hatanpää City Hospital, Tampere (R.S.), the Department of Orthopedics and Traumatology, Helsinki University Central Hospital and University of Helsinki (M.P., J.K., T.L.N.J.), and the National Institute for Health and Welfare, Center for Health and Social Economics (A.M.), Helsinki, the Department of Orthopedics and Traumatology, University of Turku, Turku (A.I.), the Department of Orthopedics, Traumatology, and Hand Surgery, Kuopio University Hospital, Kuopio (A.J.), and the Department of Orthopedics and Traumatology, Central Finland Central Hospital, Jyväskylä (H.N.) — all in Finland.
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Primary Outcomes in the Partial-Meniscectomy Group and the Sham-Surgery Group.
Lysholm knee scores (Panel A), Western Ontario Meniscal Evaluation Tool (WOMET) scores (Panel B), and scores for knee pain after exercise (Panel C) over the 12-month follow-up period are shown. Lysholm knee scores and WOMET scores range from 0 to 100, with lower scores indicating more severe symptoms; scores for knee pain after exercise range from 0 to 10, with higher scores indicating more severe pain. I bars denote 95% confidence intervals. A single value was missing for one patient in the sham-surgery group at the 6-month follow-up and for one patient in the partial-meniscectomy group at the 12-month follow-up; these values were not imputed.
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References
References
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Cullen, KA, Hall, MJ, Golosinskiy, A. Ambulatory surgery in the United States, 2006. Natl Health Stat Rep 2009;11:1-25
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Englund, M, Guermazi, A, Gale, D, et al. Incidental meniscal findings on knee MRI in middle-aged and elderly persons. N Engl J Med 2008;359:1108-1115
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Metcalf, MH, Barrett, GR. Prospective evaluation of 1485 meniscal tear patterns in patients with stable knees. Am J Sports Med 2004;32:675-680
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Kim, S, Bosque, J, Meehan, JP, Jamali, A, Marder, R. Increase in outpatient knee arthroscopy in the United States: a comparison of National Surveys of Ambulatory Surgery, 1996 and 2006. J Bone Joint Surg Am 2011;93:994-1000
5.
Holmes, R, Moschetti, W, Martin, B, Tomek, I, Finlayson, S. Effect of evidence and changes in reimbursement on the rate of arthroscopy for osteoarthritis. Am J Sports Med 2013;41:1039-1043
6.
Moseley, JB, O'Malley, K, Petersen, NJ, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 2002;347:81-88
7.
Kirkley, A, Birmingham, TB, Litchfield, RB, et al. A randomized trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 2008;359:1097-1107[Erratum, N Engl J Med 2009;361:2004.]
8.
Katz, JN, Brophy, RH, Chaisson, CE, et al. Surgery versus physical therapy for a meniscal tear and osteoarthritis. N Engl J Med 2013;368:1675-1684
9.
Sihvonen, R, Paavola, M, Malmivaara, A, Jarvinen, TL. Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of arthroscopic partial meniscectomy for patients with degenerative meniscus injury with a novel `RCT within-a-cohort' study design. BMJ Open 2013;3:e002510-e002510
10.
Altman, R, Asch, E, Bloch, D, et al. Development of criteria for the classification and reporting of osteoarthritis: classification of osteoarthritis of the knee. Arthritis Rheum 1986;29:1039-1049
11.
Kellgren, JH, Lawrence, JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis 1957;16:494-502
12.
Brittberg, M, Winalski, CS. Evaluation of cartilage injuries and repair. J Bone Joint Surg Am 2003;85:Suppl 2:58-69
13.
Cooper, DE, Arnoczky, SP, Warren, RF. Meniscal repair. Clin Sports Med 1991;10:529-548
14.
Briggs, KK, Kocher, MS, Rodkey, WG, Steadman, JR. Reliability, validity, and responsiveness of the Lysholm knee score and Tegner activity scale for patients with meniscal injury of the knee. J Bone Joint Surg Am 2006;88:698-705
15.
Tegner, Y, Lysholm, J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res 1985;198:43-49
16.
Kirkley, A, Griffin, S, Whelan, D. The development and validation of a quality of life-measurement tool for patients with meniscal pathology: the Western Ontario Meniscal Evaluation Tool (WOMET). Clin J Sport Med 2007;17:349-356
17.
Sihvonen, R, Jarvela, T, Aho, H, Jarvinen, TL. Validation of the Western Ontario Meniscal Evaluation Tool (WOMET) for patients with a degenerative meniscal tear: a meniscal pathology-specific quality-of-life index. J Bone Joint Surg Am 2012;94:e65-e65
18.
Sintonen, H. The 15D instrument of health-related quality of life: properties and applications. Ann Med 2001;33:328-336
19.
Fabricant, PD, Rosenberger, PH, Jokl, P, Ickovics, JR. Predictors of short-term recovery differ from those of long-term outcome after arthroscopic partial meniscectomy. Arthroscopy 2008;24:769-778
20.
Järvinen TLN, Sihvonen R, Bhandari M, et al. Blinded interpretation of study results can feasibly and effectively diminish interpretation bias. J Clin Epidemiol (in press).
21.
Herrlin, SV, Wange, PO, Lapidus, G, Hallander, M, Werner, S, Weidenhielm, L. Is arthroscopic surgery beneficial in treating non-traumatic, degenerative medial meniscal tears? A five year follow-up. Knee Surg Sports Traumatol Arthrosc 2013;21:358-364
22.
Yim, JH, Seon, JK, Song, EK, et al. A comparative study of meniscectomy and nonoperative treatment for degenerative horizontal tears of the medial meniscus. Am J Sports Med 2013;41:1565-1570
23.
Haynes, B. Can it work? Does it work? Is it worth it? The testing of healthcare interventions is evolving. BMJ 1999;319:652-653
24.
Hede, A, Larsen, E, Sandberg, H. Partial versus total meniscectomy: a prospective, randomised study with long-term follow-up. J Bone Joint Surg Br 1992;74:118-121
25.
Chatain, F, Adeleine, P, Chambat, P, Neyret, P. A comparative study of medial versus lateral arthroscopic partial meniscectomy on stable knees: 10-year minimum follow-up. Arthroscopy 2003;19:842-849
26.
Buchbinder, R, Osborne, RH, Ebeling, PR, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med 2009;361:557-568
27.
Kallmes, DF, Comstock, BA, Heagerty, PJ, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med 2009;361:569-579[Erratum, N Engl J Med 2012;366:970,]
28.
Buchbinder, R. Meniscectomy in patients with knee osteoarthritis and a meniscal tear? N Engl J Med 2013;368:1740-1741
29.
Finniss, DG, Kaptchuk, TJ, Miller, F, Benedetti, F. Biological, clinical, and ethical advances of placebo effects. Lancet 2010;375:686-695
30.
Lyman S, Oh LS, Reinhardt KR, et al. Surgical decision making for arthroscopic partial meniscectomy in patients aged over 40 years. Arthroscopy 2012;28(4):492.e1-501.e1.
31.
Bhattacharyya, T, Gale, D, Dewire, P, et al. The clinical importance of meniscal tears demonstrated by magnetic resonance imaging in osteoarthritis of the knee. J Bone Joint Surg Am 2003;85:4-9
32.
Ding, C, Martel-Pelletier, J, Pelletier, JP, et al. Meniscal tear as an osteoarthritis risk factor in a largely non-osteoarthritic cohort: a cross-sectional study. J Rheumatol 2007;34:776-784
33.
Englund, M, Guermazi, A, Roemer, FW, et al. Meniscal tear in knees without surgery and the development of radiographic osteoarthritis among middle-aged and elderly persons: the Multicenter Osteoarthritis Study. Arthritis Rheum 2009;60:831-839
34.
Englund, M, Niu, J, Guermazi, A, et al. Effect of meniscal damage on the development of frequent knee pain, aching, or stiffness. Arthritis Rheum 2007;56:4048-4054
35.
Roos, EM, Ostenberg, A, Roos, H, Ekdahl, C, Lohmander, LS. Long-term outcome of meniscectomy: symptoms, function, and performance tests in patients with or without radiographic osteoarthritis compared to matched controls. Osteoarthritis Cartilage 2001;9:316-324
36.
Englund, M, Lohmander, LS. Risk factors for symptomatic knee osteoarthritis fifteen to twenty-two years after meniscectomy. Arthritis Rheum 2004;50:2811-2819
37.
Katz, JN, Martin, SD. Meniscus -- friend or foe: epidemiologic observations and surgical implications. Arthritis Rheum 2009;60:633-635
38.
Hare, KB, Lohmander, LS, Christensen, R, Roos, EM. Arthroscopic partial meniscectomy in middle-aged patients with mild or no knee osteoarthritis: a protocol for a double-blind, randomized sham-controlled multi-centre trial. BMC Musculoskelet Disord 2013;14:71-71