NCT00957255撤回不适用
Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
Prospective, randomized, multi-center, controlled study for patients undergoing open rotator cuff repair. Patients are stratified based on tear size to one of three groups. Each group is then randomized 1:1 to either repair with OrthoADAPT or repair without OrthoADAPT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-70
- •MRI confirmed full thickness or high grade partial thickness rotator cuff tear equal or more than 1 cm and involving the supraspinatus and/or infraspinatus tendons
- •Tear is repairable by surgery using protocol prescribed fixation procedure
- •Patient is able to sign and IRB approved study informed consent
- •Patient is willing and able to return for follow-up appointments and study related procedures
- •Patient is willing to comply with prescribed physical therapy regimen
排除标准
- •Emergency, poly trauma patients
- •Prior same shoulder surgery including rotator cuff repair except prior subacromial decompression or distal clavicle resection
- •Shoulder pathology requiring concomitant procedures during the rotator cuff repair including Labral repair, anterior or posterior stabilization, and/or capsular plication or shift
- •Cervical spine disease
- •History of adhesive capsulitis in either shoulder
- •Patient whose injury does or may involve litigation
- •Diabetics
- •Rotator cuff tear cannot be repaired by primary surgical means including superiorly migrated humeral head, retracted rotator cuff that cannot be mobilized to humeral head, end stage tears, rotator cuff tissue cannot retain sutures, any comorbidities that would directly or indirectly affect the reparability of the cuff
- •Patients with grade 3 or 4 glenohumeral arthritis
- •Patients with systemic collage disease
- •Patients with a known hypersensitivity to equine derived materials
- •Active or latent infection
- •Chronic use of immunosuppressive agents
- •Any oral or IM NSAID usage within 5 days before surgery
- •Cancer patients
- •Decisional impaired patients
- •Pregnant women
研究组 & 干预措施
RCR without augmentation
Active Comparator
Rotator cuff repair without OrthoADAPT augmentation
干预措施: Standard of care (Procedure)
RCR with augmentation
Experimental
Rotator cuff repair with OrthoADAPT augmentation
干预措施: OrthoADAPT (Device)
结局指标
主要结局
Pain
时间窗: Pre-op, 2, 3, 4, and 6 weeks, 3, 4, 6, 12 and 24 months
Passive and active range of motion
时间窗: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
American Shoulder and Elbow Surgeons assessment score
时间窗: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
Constant shoulder score
时间窗: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
次要结局
- MRI(12 months)
- Rotator cuff re-rupture and adhesions(6 weeks, 3, 4, 6, 12 and 24 months)
- Incidence of device or procedure related adverse events(6 weeks, 3, 4, 6, 12, and 24 months)
研究者
研究点 (1)
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