Tendon Transfer Techniques for Massive Rotator Cuff Tear Repairs: An Integrated Prospective Randomized Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 12-point difference in American Shoulder and Elbow Surgeon (ASES) scores
研究概览
简要总结
This is a prospective randomized study on using muscle tendons to repair tears of the muscles on the shoulder. There are 3 muscles covering the shoulder joint- supraspinatus, infraspinatus and subscapularis. Large tears involving these muscles can be treated by using some muscle from another location of the body known as Tendon transfer techniques. These muscle tendons may be from the lower back (Latissimus Dorsi), upper pack (lower trapezius) or chest (pectoralis). There are currently no studies to show which tendon transfer technique has better outcomes.
This study comprises two trials and a total of 84 participants would be enrolled. Each trial comparing the patient reported outcomes between two tendon transfer techniques. Large tears involving the supraspinatus and infraspinatus would be repaired using either the Latissimus dorsi technique or Lower trapezius technique. 21 patients would be randomly assigned to either groups. The second trial would be comparing the Latissimus dorsi technique and pectoralis technique in large tears of the subscapularis muscle. Another 21 patients would be randomly assigned to either groups.
The investigators are studying to see if the Lower Trapezius and Pectoralis transfer techniques for muscle tear repairs would have better post-surgical outcomes compared with Latissimus Dorsi transfer technique.
For both trials, participants would be followed up for 2 years and post-surgical outcomes would be compared between treatment groups.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have massive, irreparable tear of the posterior-superior rotator cuff
- •Subjects between 18 years and 65 years (≥ 18 and ≤ 65 years of age).
- •Diagnosis of no to minimal glenohumeral arthritis- Hamada 1 and 2
- •Subject with irreparable subscapularis tendon tear (Arms 3 and 4 ONLY)
排除标准
- •Subjects having severe glenohumeral arthritis
- •History of prior tendon transfer
- •Axillary nerve injury
- •Deltoid deficiency
- •Subjects with pseudo paralysis
- •History of post-operative deep shoulder infection
- •Non-English-speaking subjects.
- •Subject has any condition, that in the opinion of the investigator, would prevent them from completing this study
- •Subject with irreparable subscapularis tendon tear (Arms 1 and 2 ONLY)
研究组 & 干预措施
Cuff tear without subscapularis tear-Lower Trapezius group
Rotator cuff tears excluding the subscapularis muscle repaired using Lower Trapezius tendon
干预措施: Lower Trapezius Tendon Transfer Technique (Procedure)
Cuff tear without subscapularis tear-Latissimus Dorsi group
Rotator cuff tears excluding the subscapularis muscle repaired using Latissimus Dorsi tendon
干预措施: Latissimus Dorsi Tendon Transfer Technique (Procedure)
Cuff tear involving subscapularis tear-Pectoralis group
Rotator cuff tears involving the subscapularis muscle repaired using Pectoralis tendon
干预措施: Pectoralis Tendon Transfer Technique (Procedure)
Cuff tear involving subscapularis tear-Latissimus Dorsi group
Rotator cuff tears involving the subscapularis muscle repaired using Latissimus Dorsi tendon
干预措施: Latissimus Dorsi Tendon Transfer Technique (Procedure)
结局指标
主要结局
12-point difference in American Shoulder and Elbow Surgeon (ASES) scores
时间窗: At one year post-operative follow-up visit
The American Shoulder and Elbow Surgeon (ASES) score is a validated and reliable outcomes measure in patients with a wide variety of shoulder disorders. The ASES questionnaire examines two domains- pain (50 points) and function (50 points)- in a self-reported questionnaire and is scored on a 100-point scale. The minimum score is zero and the maximum is 100. A higher score means better outcome.
次要结局
未报告次要终点
研究者
Ashfaq Hasan
Associate Professor
University of Maryland, Baltimore