An Outcomes Study Utilizing Allomend(R) HD for Superior Capsular Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Acromiohumeral interval change
研究概览
简要总结
Rotator cuff tears can usually be repaired with excellent results, however some chronic, extensive rotator cuff tears are not reparable secondary to tendon retraction with inelasticity, muscle atrophy, and fatty infiltration. Arthroscopic superior capsular reconstruction (SCR) utilizing allograft or autograft tissue has been shown to restore superior glenohumeral stability and function of the shoulder joint in patients with irreparable rotator cuff tears. Grafts utilized for SCR have included fascia lata, hamstring autograft, human acellular dermal tissue matrix (HADTM), and acellular porcine dermal xenograft. Due to donor morbidity associated with autografts and the graft rejection potential of xenograft, HADTM has become a common graft of choice for SCR. The purpose of this study is to determine if patients treated with SCR using AlloMend have acceptable clinical and anatomic outcomes.
详细描述
Rotator cuff tears can usually be repaired with excellent results, however some chronic, extensive rotator cuff tears are not reparable secondary to tendon retraction with inelasticity, muscle atrophy, and fatty infiltration. Arthroscopic superior capsular reconstruction (SCR) utilizing allograft or autograft tissue has been shown to restore superior glenohumeral stability and function of the shoulder joint in patients with irreparable rotator cuff tears.Grafts utilized for SCR have included fascia lata, hamstring autograft, human acellular dermal tissue matrix (HADTM), and acellular porcine dermal xenograft. Due to donor morbidity associated with autografts and the graft rejection potential of xenograft, HADTM has become a common graft of choice for SCR. The purpose of this study is to determine if patients treated with SCR using AlloMend have acceptable clinical and anatomic outcomes. We predict there will be significant improvement in radiographic, clinical, and patient reported outcomes in patients undergoing SCR for extensive, primarily irreparable rotator cuff tears when AlloMend allograft is utilized.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subjects who are undergoing SCR for massive rotator cuff
- •Adult patients (≥18)
- •Pre-operative MRI obtained within 26 weeks prior to surgery
- •Must have 3 out of 5 external rotation strength
- •Must have intact teres minor
排除标准
- •Worker's Compensation Case
- •Persons with a mental or cognitive disability deemed significant enough that they would not be capable of complying with a restricted rehabilitation program or completing the outcome measures
- •Patients with known contraindications to MRI
- •Pectoralis major, pectoralis minor, deltoid, or latissimus dorsi dysfunction
- •Acute fractures of humerus, clavicle, scapula
- •Inability to speak and/or understand English
- •Intra-Op Exclusion Criteria:
- •Anterosuperior escape of the glenohumeral joint due to a completely incompetent anterosuperior cuff and coracoacromial ligament (CAL)
- •Unable to fix the graft on the humeral side utilizing a double row repair
- •Inability to address subscapularis pathology
- •Diffuse bipolar cartilage loss
结局指标
主要结局
Acromiohumeral interval change
时间窗: 24 months
Xrays will be used to compare the amount of superior humeral migration between 12 month xrays and 24 month xrays
Rotator Cuff Integrity and Graft Incorporation
时间窗: 24 months
These will be assessed via MRI with Arthrogram- changes will be compared between the 12 and 24 month time points
Clinical Failure
时间窗: Within 24 months
Revision Surgery
次要结局
- Shoulder Pain(24 months)
- Range of Motion(24 months)
- Function (Activities of Daily Living)(24 months)
- Resilience(24 months)
- Function (Overall Normal rating)(24 months)