Biceps Tenodesis Versus Tenotomy in the Treatment of Lesions of the Long Head of Biceps Brachii: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- American Should and Elbow Society (ASES)
研究概览
简要总结
The long head of biceps brachii tendon has been known to be a pain generator and a common cause of shoulder pain and dysfunction in patients with rotator cuff pathology. Both biceps tenotomy and tenodesis have been shown to produce comparable results, but there is no consensus to date due to a lack of level I evidence. The aim of this prospective, randomized, clinical trial is to compare subjective patient-reported outcomes and objective clinical results between biceps tenotomy and biceps tenodesis for treating lesions of the long head of the biceps brachii.
详细描述
Methodology
Patients will be screened in clinic and, if deemed appropriate for the study, will be approached by the research coordinator who will review the study and provide the opportunity for consenting to participate. The surgical procedure will be performed using standard arthroscopic technique and patients will be randomized intra-operatively via computer randomization when a biceps tendon lesion is confirmed. The type of anchor for the tenodesis, whether bioabsorbable or metal, and the manufacture of the anchor used is at the discretion of the surgeon. Duration of the surgery will be between 60-120 minutes.
Surgical Technique
The technique can be done using a biceps groove or a subpectoral level of fixation depending on surgeon preference. Shoulder arthroscopy is conducted in the lateral decubitus or beach chair position. Diagnostic arthroscopy is performed using a standard posterior portal and the biceps tendon is assessed with an arthroscopic probe using a standard anterior interval portal. Once study eligibility was confirmed via identification of tearing or degeneration of the long head of biceps, the patient was randomized to undergo either tenodesis or tenotomy.
For patients who undergo biceps tenotomy the long head of biceps tendon is detached from its proximal anchor to the superior labrum using an arthroscopic biter, an electrothermal device, or a scalpel based on individual surgeon preference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Must benefit from arthroscopic rotator cuff surgery and inta-operative findings must confirm a lesion of the long head of biceps tendon
排除标准
- •Any significant comorbidities including previous surgery on affected shoulder
- •Active worker's compensation claims
- •Active joint or systemic infection, significant muscle paralysis, Charcot's arthropathy
- •Significant medical comorbidity that could alter the effectiveness of the surgical intervention (e.g., Cervical radiculopathy, polymyalgia rheumatica)
- •Major medical illness (life expectancy less then one year or unacceptably high operative risk)
- •Inability to speak or read English/French
- •Psychiatric illness that precludes informed consent
- •Unwillingness to be followed for 2 years.
结局指标
主要结局
American Should and Elbow Society (ASES)
时间窗: 24 months
次要结局
- Complications(24 months)
- Operative Time(24 months)
- Incidence of Revision(24 months)
- Strength(24 months)
- Range of Motion(24 months)
- Magnetic Resonance Imaging (MRI)(24 months)
研究者
Peter MacDonald
Department Head, Orthopaedics
Panam Clinic