Arthroscopic Rotator Cuff Repair With and Without Arthroscopic Acromioplasty in the Treatment of Full Thickness Rotator Cuff
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Western Ontario Rotator Cuff Index (WORC)
研究概览
简要总结
Surgical repair of full thickness tears of the rotator cuff is a controversial issue, with several procedures currently being used to treat the tear. The two most common treatments at this point in time are arthroscopic cuff repair with and without acromioplasty. However, an arthroscopic cuff repair without acromioplasty may offer the same degree of improvement as one that includes acromioplasty, but without threatening the shoulder stability that is provided by the acromion and coracoacromial ligament. This prospective study examines the hypothesis that appropriate shoulder function can be restored through the execution of the traditional arthroscopic cuff repair without acromioplasty.
详细描述
There exists some controversy in the current trend in repair of full thickness tears of the rotator cuff. The two most common treatments at this point in time are arthroscopic cuff repair with and without acromioplasty. The purpose of acromioplasty is to create adequate space for the rotator cuff tendons. Arthroscopic acromioplasty involves the removal of the subacromial bursa, resection of the coracoacromial ligament and anteroinferior portion of the acromion, and resection of any osteophytes from the acromioclavicular joint that are thought to be contributing to impingement. However, acromioplasty without cuff repair has been reported to have both good and poor results, showing that the technique may be suspect in repair of full thickness tears alone.
The purpose of this study is to compare the effectiveness of arthroscopic cuff repair with acromioplasty to arthroscopic cuff repair without acromioplasty in repair of full thickness tears of the rotator cuff.
We hypothesize that there will be a significant clinical improvement in quality of life in patients who receive a rotator cuff repair without acromioplasty compared to those who receive a cuff repair with acromioplasty.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 or older
- •Complete rotator cuff tear up to 4 cm in size
- •Persistent pain and functional disability for at least 6 months
- •Failure of conservative treatment
- •Establishment of final eligibility based upon visual exam of rotator cuff tear during surgery and determination of repairability
排除标准
- •Evidence of significant osteoarthritis or cartilage damage in the shoulder
- •Evidence of glenohumeral instability including Bankart lesions and labral tears of any type
- •Previous surgeries of the shoulder
- •Evidence of major joint trauma, infection, or necrosis in the shoulder
- •Patients with partial thickness tears of the rotator cuff
- •Patients unable to provide informed consent due to language barrier or mental status
- •Patients with a major medical condition that would affect quality of life and influence the results of the study
- •Patients with worker compensation claims
- •Patients unwilling to be followed for the duration of the study
结局指标
主要结局
Western Ontario Rotator Cuff Index (WORC)
时间窗: 24 months
Calculated as percentage with an increase in score indicating an improvement in outcome.
American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)
时间窗: 24 months
Calculated as a percentage with an increase in score reflecting an improvement in outcome.
次要结局
- Shoulder Range of Motion(24 months)
- Upper Extremity Strength Grading(24 months)
研究者
Peter MacDonald
Department Head, Orthopaedics
Panam Clinic