A Prospective Randomized Study Comparing Suture Anchor and Soft Tissue Pectoralis Major Tendon Techniques for Biceps Tenodesis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 6
- 主要终点
- Change in Long Head of the Biceps Tendon Score (LHB)
研究概览
简要总结
This is a prospective randomized controlled trial comparing two common techniques of long head of biceps tendon tenodesis in shoulder surgery. Numerous techniques of biceps tenodesis currently exist and are commonly performed. We will be comparing the tenodesis procedure using a suture anchor device versus a technique where the tendon is simply sutured to the pectoralis major tendon.
详细描述
Biceps tenodesis is a commonly performed procedure in shoulder surgery. In many cases, it is performed in conjunction with a rotator cuff repair. Currently, biceps tenodesis is performed in many different ways depending on surgeon preference. First, the location of the tenodesis can vary, as surgeons may prefer a suprapectoral or subpectoral tenodesis location. In addition, the tenodesis fixation technique can also vary, as surgeons have the option to use a screw or suture anchor to perform the tenodesis. There have been numerous studies comparing these various techniques, including suprapectoral versus subpectoral techniques and screw versus suture anchor techniques. None of these studies have been conclusive, and there continues to be controversy as to the best technique.
The current study will compare two techniques of subpectoral biceps tenodesis. Specifically, we will compare tenodesis using a suture anchor versus a technique where the tendon is simply sutured to the pectoralis major tendon. The latter technique has been previously described and published.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 100 years
- •Able to provide written informed consent
- •Has: (a) partial- or full-thickness rotator cuff tear verified by preoperative magnetic resonance imaging (MRI) and arthroscopy; (b) concomitant biceps lesions (LHBT partial tear>50%, SLAP type II lesion, pulley lesion, or subluxation/dislocation of LHBT) that were diagnosed arthroscopically with concomitant symptoms; and (c) arthroscopic rotator cuff repair.
排除标准
- •Any medical illness that adversely impacts the patient's ability to complete the study procedures
- •Isolated glenohumeral pathological conditions
- •Any prior surgery on the same shoulder
- •Complete rupture of the LHBT assessed by MRI or at time of procedure
- •Incomplete repair of the rotator cuff
结局指标
主要结局
Change in Long Head of the Biceps Tendon Score (LHB)
时间窗: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.
The LHB score is a composite endpoint (maximum 100 points) that evaluates 'biceps pain and muscle cramps', 'cosmesis', and 'flexion strength at the elbow'. It is an outcome score specific for biceps tendon pathology. The score range is 0-100, with a higher score representing better function. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
次要结局
- Change in Visual Analogue Scale (VAS)(This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.)
- Change in Disabilities of the Arm, Shoulder, and Hand Score (DASH)(This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.)
- Change in Single Assessment Numeric Evaluation (SANE)(This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.)
- Change in American Shoulder and Elbow Surgeons (ASES) Shoulder Score(This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.)
研究者
Howard M Place
Department Chair
St. Louis University