Patch Study: a Single-center, Prospective, Single-blind, Randomized, Two-arm Controlled Study of Outcomes Following Synthetic Polyester Patch-augmented Rotator Cuff Repair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Rotator cuff retear rate
研究概览
简要总结
This single-center, prospective, randomized controlled study will compare patients allocated to two treatment arms who are undergoing surgery to repair rotator cuff tears: (1) arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch, and (2) arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch. The primary objective is to compare complications (primarily retear rates) and the secondary objective is to compare mid- and long-term clinical and radiological outcomes using standard orthopedic assessments, such as the subjective shoulder value and the Constant-Murley score.
详细描述
This single-center, prospective, randomized controlled study will compare patients allocated to two treatment arms who are undergoing surgery to repair rotator cuff tears: (1) arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch, and (2) arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch. The primary objective is to compare complications (primarily retear rates) and the secondary objective is to compare mid- and long-term clinical and radiological outcomes using standard orthopedic assessments, such as the subjective shoulder value and the Constant-Murley score.
The Pitch-Patch is a single-use synthetic polyester patch (Pitch-Patch, neoligamentsTM, Leeds, UK) intended to reinforce the rotator cuff following or during repair by sutures or suture anchors where weakness exists in the soft tissue. The surgical group will be randomly assigned, and each group will include 150 patients. After surgery, patients will be followed for two years and undergo clinical and radiological assessments.
The main research question to be answered by this investigation is whether synthetic patch augmentation can significantly improve outcomes in patients with rotator cuff tears from either degenerative or traumatic origins versus patients with no patch augmentation.
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)
盲法说明
Single blind study in which only patients will not be aware of treatment (with or without rotator cuff augmentation with polyester patch)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with massive rotator cuff tear
- •Tear must affect at least two tendons
- •Primary surgery only
- •Origin of tear can be either degenerative or traumatic
- •German language speaking
排除标准
- •Fatty infiltration grade 4 (according to Goutallier)
- •Bilateral tears
- •Cases of arthritis or severe osteoarthritis
- •Structural or pathological condition of the bone or soft tissue that could impair healing
- •Unable or unwilling to restrict activities to prescribed levels or follow rehabilitation guidelines
- •Unable or unwilling to give consent (language barrier or cognitive impairment)
- •Unwilling or unable to be assessed at 1- and 2-year follow-up assessment visits
结局指标
主要结局
Rotator cuff retear rate
时间窗: Up to two years postoperative
Occurence of retear following rotator cuff reconstruction to treat massive tear (measured using radiological imaging/ultrasound)
次要结局
- Pain levels(Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits))
- Complication rate (adverse event greater than grade 2)(Up to two years postoperative)
- Healing rate(6-week and 1-year exams (postoperative))
- Range of motion(Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits))