Comparison of Repair Integrity and Functional Outcomes Between Knot-tying and Knotless Suture-bridge Arthroscopic Rotator Cuff Repair: a Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Koray Sahin
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Sugaya classification of rotator cuff integrity
研究概览
简要总结
Suture-bridge technique has been widely used for rotator cuff tears with many studies showing superior clinical results and lower failure rates compared to other techniques. This study aims to compare clinical outcomes and radiological integrity of arthroscopic rotator cuff repair between knot-tying and knotless suture-bridge techniques. The possibility of tendon strangulation and necrosis at the medial row when performing a suture-bridge technique may lead to retear and structural failure. In order to avoid this complication, the knots used at the medial row and their tension might be a factor to consider. Our hypothesis is that a knotless suture-bridge technique might avoid tendon strangulation thus might have lower retear rates.
详细描述
This study has been planned as a prospective randomized clinical trial. We used a completely computer-generated list in order to randomize all participants to receive one of two treatments (https://www.random.org/sequences/).
Rotator cuff tear diagnosis will be made by physical examination and magnetic resonance imaging. Participants who agree to be enrolled to study will be examined one day prior to surgery. Half of the participants will undergo an arthroscopic rotator cuff repair with knot-tying suture-bridge technique, while the other half will receive a knotless suture-bridge technique. All the surgeries will be performed by the same senior surgeon experienced in shoulder surgery under general anesthesia with participant in beach-chair position.
All participants will receive a standard postoperative rehabilitation program starting immediately after surgery with active elbow and passive shoulder exercises. The operated upper extremity will be placed in a sling for 6 weeks. Active-assisted exercises will be started at 6 weeks postoperatively.
Postoperative evaluations will be performed regularly at 2 weeks, 6 weeks, 3 months, 6 months, 12 months postoperatively and each following year. The results of last follow-up will be analyzed. To assess repair integrity and tendon healing, a postoperative magnetic resonance imaging scan will be performed to all participants at 6 months postoperatively. The results of prospective clinical follow-up data and radiological evaluation will be analyzed in order to compare clinical outcomes, failure rates and patterns of knot-tying and knotless suture-bridge arthroscopic rotator cuff repair techniques.
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 (Participant)
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
- •Full thickness rotator cuff tear repaired by arthroscopic suture-bridge technique
排除标准
- •Partial thickness rotator cuff tear
- •Presence of a full thickness subscapularis tear that requires a repair
- •History of a neurological disease
- •Presence of severe glenohumeral or acromioclavicular arthritis
- •Presence of a metal implant which prevents magnetic resonance imaging scan
- •Tears repaired with other techniques
- •Revision surgeries
结局指标
主要结局
Sugaya classification of rotator cuff integrity
时间窗: 6 months postoperatively
This is a classification system described by Sugaya et al. which uses magnetic resonance imaging in order to evaluate tendon integrity after rotator cuff repair. Postoperative cuff integrity is classified into 5 categories: type I, sufficient thickness with homogenously low intensity; type II, sufficient thickness with partial high intensity; type III, insufficient thickness without discontinuity; type IV, presence of minor discontinuity; type V, presence of major discontinuity
Constant shoulder score
时间窗: Change from baseline Constant shoulder score at 12 months
This is a clinical functional assessment test used for shoulder disorders. The score consists of 4 sections: pain, activities of daily living, mobility and strength.
次要结局
- Shoulder range of motion(Change from baseline range of motion at 12 months)
- Visual analog scale for pain(Change from baseline visual analog scale for pain at 12 months)
- Retear patterns of rotator cuff tendons(6 months postoperatively)
研究者
Koray Sahin
Resident in orthopedics and traumatology department
Istanbul University