Lovisenberg Deakonal Hospital, Lovisenberggaten 17, 0440 Oslo, Norway.
BMC Musculoskelet Disord. 2010 Oct 7;11:228. doi: 10.1186/1471-2474-11-228.
Surgery for type II SLAP (superior labral anterior posterior) lesions of the shoulder is a promising but unproven treatment. The procedures include labral repair or biceps tenodesis. Retrospective cohort studies have suggested that the benefits of tenodesis include pain relief and improved function, and higher patient satisfaction, which was reported in a prospective non-randomised study. There have been no completed randomised controlled trials of surgery for type II SLAP lesions. The aims of this participant and observer blinded randomised placebo-controlled trial are to compare the short-term (6 months) and long-term (2 years) efficacy of labral repair, biceps tenodesis, and placebo (diagnostic arthroscopy) for alleviating pain and improving function for type II SLAP lesions.
METHODS/DESIGN: A double-blind randomised controlled trial are performed using 120 patients, aged 18 to 60 years, with a history for type II SLAP lesions and clinical signs suggesting type II SLAP lesion, which were documented by MR arthrography and arthroscopy. Exclusion criteria include patients who have previously undergone operations for SLAP lesions or recurrent shoulder dislocations, and ruptures of the rotator cuff or biceps tendon. Outcomes will be assessed at baseline, three, six, 12, and 24 months. Primary outcome measures will be the clinical Rowe Score (1988-version) and the Western Ontario Instability Index (WOSI) at six and 24 months. Secondary outcome measures will include the Shoulder Instability Questionnaire (SIQ), the generic EuroQol (EQ-5 D and EQ-VAS), return to work and previous sports activity, complications, and the number of reoperations.
The results of this trial will be of international importance and the results will be translatable into clinical practice.
[ClinicalTrials.gov NCT00586742].
对于肩二型 SLAP（上盂唇前后向）病变的手术治疗是一种有前途但未经证实的治疗方法。手术包括盂唇修复或二头肌肌腱固定术。回顾性队列研究表明，肌腱固定术的益处包括缓解疼痛和改善功能，以及更高的患者满意度，这在一项前瞻性非随机研究中得到了报道。对于二型 SLAP 病变的手术治疗，目前还没有完成的随机对照临床试验。本参与者和观察者盲法随机安慰剂对照试验的目的是比较盂唇修复、二头肌肌腱固定术和安慰剂（诊断性关节镜检查）在缓解疼痛和改善二型 SLAP 病变功能方面的短期（6 个月）和长期（2 年）疗效。
方法/设计：一项双盲随机对照临床试验，纳入 120 名年龄在 18 至 60 岁之间的患者，这些患者有二型 SLAP 病变的病史和临床体征，这些体征通过 MR 关节造影和关节镜检查记录。排除标准包括以前接受过 SLAP 病变手术或复发性肩关节脱位以及肩袖或二头肌肌腱撕裂的患者。结局将在基线、3 个月、6 个月、12 个月和 24 个月进行评估。主要结局指标是 6 个月和 24 个月时的临床 Rowe 评分（1988 版）和 Western Ontario 不稳定指数（WOSI）。次要结局指标包括肩不稳定问卷（SIQ）、通用欧洲五维健康量表（EQ-5 D 和 EQ-VAS）、重返工作和以前的运动活动、并发症以及再次手术的次数。
该试验的结果具有国际重要性，结果将转化为临床实践。
[ClinicalTrials.gov NCT00586742]。
