A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair: Soft Tissue or Bone Trephination, a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Western Ontario Rotator Cuff Index
研究概览
简要总结
This Clinical Trial is being conducted to study two adjunctive treatments for rotator cuff repair; soft tissue and bone trephination. "Trephination" is a procedure that involves making small perforations either in the torn tendon near its edge, or in the bone that the tendon is repaired to. The rotator cuff is repaired by sewing the tendon down to the bone in the shoulder. Trephination is a new technique that is used in addition to the standard method of repairing the rotator cuff tendon.
This study will help to determine whether this technique improves the speed of healing, the strength and the re-tear rate of the repair. You are being asked to take part in this study because you have a tear of the rotator cuff that requires surgical treatment. A total of 90 participants will participate in this study.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have failed standard non-surgical management of their rotator cuff tear, and who would benefit from a surgical repair of the cuff.
- •Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for 6 months.
- •Medical management will be defined as:
- •The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
- •Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc)
- •Activity modification
- •Imaging, and intra-operative findings confirming a full thickness tear of the rotator cuff.
排除标准
- •Characteristics of the cuff tear that render the cuff irrepairable: fatty infiltration in the muscles grade III (50%) or greater; superior subluxation of the humeral head; retraction of the cuff to the level of the glenoid rim.
- •Partial thickness cuff tears.
- •Significant shoulder comorbidities e.g. Bankart lesion, osteoarthritis
- •Previous surgery on affected shoulder e.g. Previous rotator cuff repair.
- •Patients with active worker's compensation claims
- •Active joint or systemic infection
- •Significant muscle paralysis
- •Rotator cuff tear arthropathy
- •Charcot's arthropathy
- •Significant medical comorbidity that could alter the effectiveness of the surgical intervention (eg. Cervical radiculopathy, polymyalgia rheumatica)
- •Major medical illness (life expectancy less then 1 year or unacceptably high operative risk)
- •Unable to speak or read English/French
- •Psychiatric illness that precludes informed consent
- •Unwilling to be followed for 1 year
- •Advanced physiologic age
结局指标
主要结局
Western Ontario Rotator Cuff Index
时间窗: From baseline to up until 24-Months Post-Operative
The Western Ontario Rotator Cuff Index (WORC) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WORC is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome. These scores are combined and translated into a percentage out of 100. A higher total score indicates a better outcome.
次要结局
- American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Scores(From baseline to up until 24-Months Post-Operative)
- The Constant Score(From baseline to up until 24-Months Post-Operative)
- Healing Rates(From surgery to up until 24-Months Post-Operative)