Matache Bogdan A, Berdusco Randa, Momoli Franco, Lapner Peter L C, Pollock J W
Division of Orthopaedic Surgery, University of Ottawa, Ottawa, Ontario, Canada.
Orthopedic Shoulder, Knee and Sports Injuries, Pan Am Clinic, University of Manitoba, Manitoba, Canada.
BMC Musculoskelet Disord. 2016 Jun 1;17:239. doi: 10.1186/s12891-016-1093-9.
Tennis elbow is a common elbow pathology typically affecting middle-aged individuals that can lead to significant disability. Most cases resolve within 2 years of symptom onset, but a subset of patients will develop persistent symptoms despite appropriate conservative management. There are several surgical approaches used to treat chronic tennis elbow, with arthroscopic surgery becoming an increasingly popular approach to address this pathology in North America. This procedure involves the arthroscopic release of the extensor carpi radialis brevis tendon (ECRB) origin at the elbow. The potential benefit of arthroscopic treatment of this condition is improved patient outcomes and shorter recovery time following surgery. The results of this technique have been reported only in the context of case series, which have shown positive results. However, in order to justify its widespread use and growing popularity, a high level of evidence study is required. The purpose of this prospective, randomized sham-controlled trial is to determine whether arthroscopic tennis elbow release is effective at treating chronic lateral epicondylitis.
We will conduct a prospective single center, double-blind, randomized sham-controlled parallel arm trial evaluating the efficacy of arthroscopic tennis elbow release in adult patients with symptoms for at least 6 months. Patients will undergo intraoperative randomization after diagnostic arthroscopy of the elbow to receive either ECRB release (through the creation of a lateral portal) or a sham lateral portal and no ECRB release. The primary outcome will be the Mayo Elbow Performance Score (MEPS) at 1 year follow-up. Secondary outcomes will be the abbreviated Disability of the Shoulder and Hand (DASH) score, American Shoulder and Elbow Surgeons elbow (ASES-e) score and grip strength at 3, 6, 12 and 24 months as well as return-to-work time, ability to return to full duty and adverse outcomes.
Results of this study will provide empirical high quality evidence to guide clinical decision-making in patients with chronic tennis elbow.
NCT02236689 (September 8, 2014).
网球肘是一种常见的肘部病变，通常影响中年人群，可导致严重残疾。大多数病例在症状出现后2年内缓解，但一部分患者尽管接受了适当的保守治疗仍会出现持续症状。有几种手术方法用于治疗慢性网球肘，在北美，关节镜手术成为治疗这种病变越来越受欢迎的方法。该手术包括在肘部关节镜下松解桡侧腕短伸肌腱（ECRB）起点。关节镜治疗这种疾病的潜在益处是改善患者预后并缩短术后恢复时间。该技术的结果仅在病例系列中报道过，显示出了积极的结果。然而，为了证明其广泛应用和日益普及的合理性，需要进行高水平证据的研究。这项前瞻性、随机假手术对照试验的目的是确定关节镜下网球肘松解术治疗慢性外侧上髁炎是否有效。
我们将进行一项前瞻性单中心、双盲、随机假手术对照平行组试验，评估关节镜下网球肘松解术对有至少6个月症状的成年患者的疗效。患者在肘部诊断性关节镜检查后进行术中随机分组，接受ECRB松解（通过建立外侧入路）或假外侧入路且不进行ECRB松解。主要结局将是1年随访时的梅奥肘关节功能评分（MEPS）。次要结局将是3、6、12和24个月时的简化肩手残疾（DASH）评分、美国肩肘外科医师学会肘关节（ASES-e）评分和握力，以及重返工作时间、恢复全职工作的能力和不良结局。
本研究结果将提供高质量的实证证据，以指导慢性网球肘患者的临床决策。
NCT02236689（2014年9月8日）。
