A Randomised Controlled Trial of Accelerated Rehabilitation Versus Standard Rehabilitation After Double-row Rotator Cuff Repair. Does Rehabilitation Regimen Affect Clinical Outcomes?
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Oxford Shoulder Score
研究概览
简要总结
This is a randomised controlled trial involving patients who have a double-row arthroscopic rotator cuff repair.
Null hypothesis: There is no difference in outcome between standard rehabilitation and accelerated rehabilitation after arthroscopic rotator cuff repair.
Following surgery, they will be randomised to one of two groups:
- Standard rehabilitation, with enforced sling use for 6 weeks and a structured exercise programme.
- Accelerated rehabilitation with no requirement to use a sling and a structured exercise programme.
The primary outcome measure will be the Oxford Shoulder Score at 6 months. We will also collect data on postoperative pain, range of shoulder movement and other subjective outcome measures. All patients will have MRI scans at 6 months postoperatively to assess the integrity of the repair, allowing comparison of failure rates between groups.
详细描述
This is a randomised controlled trial involving patients who have a double-row arthroscopic rotator cuff repair. We wish to compare clinical and radiological outcomes for patients undergoing standard rehabilitation protocols versus accelerated rehabilitation.
A double-row repair will be used in this study as it has been shown in laboratory testing to be stronger and withstand significantly more cyclical loads before failure.
Patients who have failed conservative treatment for their rotator cuff tears will be offered inclusion in the study. Baseline scores and measurements will be taken prior to surgery. After a successful surgical repair has been confirmed, patients will be randomised to one of two rehabilitation programmes. One programme will mandate use of a sling for 6 weeks, and another will not require use of a sling after the immediate postoperative period.
All patients will be followed up for one year, at intervals of 6 weeks, 3 months, 6 months and 12 months, using subjective outcome measures, objective measures of movement and an MRI scan to assess the integrity of the repair at 6 months.
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 (Outcomes Assessor)
盲法说明
The therapist assessing patients' range of movement and the radiologist assessing integrity of the repair will be blinded to the arm of the trial that the patient entered.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged over 40 with a degenerate full-thickness posterosuperior rotator cuff tear undergoing arthroscopic rotator cuff repair (+/- concomitant procedures such as biceps tenotomy and subacromial decompression).
排除标准
- •Other musculoskeletal disease affecting same limb
- •Massive rotator cuff tear
- •Subscapularis tear
- •Incomplete cuff repair
- •Repair under tension
- •Non-English speaker
- •Inability to follow postoperative instructions / restrictions
研究组 & 干预措施
Traditional Rehabilitation
In this arm, patients will undergo the standard rehabilitation protocol, with sling use for 6 weeks.
干预措施: Traditional rehabilitation protocol (Other)
Accelerated Rehabilitation
In this arm, patients will undergo the accelerated rehabilitation protocol, with no sling use outside the immediate postoperative period.
干预措施: Accelerated rehabilitation protocol (Other)
结局指标
主要结局
Oxford Shoulder Score
时间窗: 3 months
A validated patient-reported outcome measure of shoulder function. This score ranges from 0-48, with higher scores representing a better outcome.
次要结局
- Range of shoulder movement(6 weeks, 3 months, 6 months, 12 months postoperatively.)
- Oxford Shoulder Score(6 weeks, 3 months, 6 months, 12 months postoperatively.)
- EQ5D(6 weeks, 3 months, 6 months, 12 months postoperatively.)
- Postoperative pain score(6 weeks)
- Shoulder Pain and Disability Index(6 weeks, 3 months, 6 months, 12 months postoperatively.)
- Structural integrity of repair(6 months.)