Functional and Anatomical Results Following Arthroscopic Cuff Repair
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Rate of re-tear at 1 year
研究概览
简要总结
There are two ways in which surgeons repair rotator cuff tears. An open method involves making an incision (cut) 5-6 inches in length in the skin and repairing the tear with the skin open, while the arthroscopic method involves making small holes in the skin and using a guiding camera and special equipment to repair the tear. This clinical study is being conducted to study the rate of re-tear (one year following surgery) of rotator cuffs that have been repaired using the arthroscopic technique.
详细描述
While many studies have researched re-tear rate for rotator cuff tears following open repair, to date there have been no studies evaluating re-tear rate following arthroscopic surgery. Arthroscopic rotator cuff repair is less invasive and exposes the patient to fewer risks than open surgery. Once this pilot study is completed the next step will be to compare the rate of re-tear, as assessed via Magnetic Resonance Imaging (MRI) between the two techniques. If the rate of re-tear is lower following arthroscopic surgery this will provide validation for use of the arthroscopic technique. If, however, the rate of re-tear is higher using the arthroscopic technique, then use of this technique is not justified.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of rotator cuff tear which will involve one of the following:1) history of shoulder pain or weakness 2) ability to illicit pain or weakness with one of the following signs: tenderness of the rotator cuff insertion, palpable crepitus of the subacromial bursa or a palpable defect of the cuff insertion, impingement signs and weakness of the rotator cuff musculature 3) radiological evidence of rotator cuff tear from ultrasound, arthrogram or MRI. Failed non-operative treatment. Size of tear of less than 5 cm and involving 2 or fewer tendons
排除标准
- •Clinical:
- •Tear as defined by significant muscular wasting, inability to actively forward-flex (strength grade 2/5 or worse), positive drop sign or hornblowers
- •Significant tenderness of acromioclavicular or sternoclavicular joints on affected side
- •Presence of comorbid shoulder instability or evidence of SLAP lesion
- •Previous surgery on affected shoulderRadiological:
- •Bony abnormality on standardized series of x-rays consisting of a minimum of an antero-posterior view, lateral “Y” view in the scapular plane, and an axillary view.
- •Presence of massive cuff tear on MRI or ultrasound (defined as > 5 cm or greater than 2 tendons torn).Arthroscopic:
- •Presence of massive cuff tear as defined above on arthroscopic examination of the joint
- •Presence of comorbid conditions: Bankart lesion, SLAP lesion
- •Inability to complete the repair arthroscopically (eg. partial repair by marginal convergence without direct repair to bone)Other:Patients who have any contraindication to MRI (including claustrophobia, intracranial aneurism clip, cardiac pacemaker, middle ear prosthesis, metallic heart valve prosthesis, prior metal fragment in eye (intraocular lens implant) etc.
结局指标
主要结局
Rate of re-tear at 1 year
时间窗: 1 year
The rate of rotator cuff re-tear will be measured 1-year post-operatively using a Magnetic Resonance Imaging (MRI) Arthrogram.
次要结局
- Functional Status Anatomical integrity(1 year)