Bridging Reconstruction of Massive Rotator Cuff Tears by Human Dermal Allograft Augmentation Compared to Superior Capsular Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Maintenance of Acromiohumeral Distance
研究概览
简要总结
To compare bridging reconstruction to superior capsular reconstruction using human dermal allograft augmentation for repair of massive rotator cuff tears.
详细描述
A total of 60 patients will be enrolled in the study. In the pre-operative period, there will be no additional time requirements for the patient, except for the informed consent process for the study. Routine radiographs including an AP and Y view of the shoulder as well as a pre-operative MRI are obtained for all patients undergoing rotator cuff surgery.
The patients will complete a structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant. The examination will consist of range of motion testing by goniometer as well as strength testing by hand dynamometer. The patient will also complete the WORC questionnaire.
Surgical Technique
All patients will undergo a 15-point arthroscopic shoulder examination as per the method outlined by Snyder. An arthroscopic acromioplasty will be performed if needed according to the technique described by Snyder. The bursal side of the tear will be evaluated. If the cuff can be re-approximated to its anatomic position on the greater tuberosity without excessive tension, a standard rotator cuff reconstruction will be attempted. If this is not possible the surgeon will determine that the cuff is "irreparable" and the randomization envelope will be opened.
Wong et al. described the surgical procedure for patients in the "Bridging" group. The bursa will be debrided thoroughly and rotator cuff edges will be shaved down to stable tissue. Following this, an acellular human dermal patch will be rehydrated in saline solution for 15 minutes. The patch is stretched to remove the manufacturing surface irregularities. The patch is then sewn in place with braided polyester suture material. Multiple sutures, approximately 5 to 10 mm apart from one another will be used. The medial sutures are placed into the remnants of supraspinatus and infraspinatus tendons. The patch is then attached to the greater tuberosity in a double row configuration.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Magnetic resonance imaging (MRI) proven diagnosis of a large or massive (>3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff
排除标准
- •Presence of subscapular tear
- •Presence of glenohumeral osteoarthritis
- •WORC score > 70%
- •Uncontrolled diabetes
- •Pregnancy
- •Presence of local or systemic infection
- •Paralysis of the shoulder
- •Poor nutritional state
- •Contracture of the shoulder
- •Presence of cuff tear arthropathy
- •MRI proven nonvascular surgical sites
结局指标
主要结局
Maintenance of Acromiohumeral Distance
时间窗: 24 months
The primary objective of this study is to compare the effect between the two surgical techniques, arthroscopic SCR for a massive, chronic irreparable tear of the rotator cuff vs. BRR with an acellular human dermal allograft implant, on the maintenance of the Acromiohumeral distance. Acromiohumeral Distance is measured in mm and determine through xray.
次要结局
- Changes in Patient Reported Outcomes using the Western Ontario Rotator Cuff Index (WORC)(24 months)
- Changes in Shoulder Range of Motion After Surgery(24 months)
- Changes in Shoulder Strength After Surgery(24 months)
研究者
Ivan Wong
Orthopaedic Surgeon MD FRCS(C), Dip. Sports Medicine
Nova Scotia Health Authority