Demineralized Bone Matrix Rotator Cuff Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- MRI
研究概览
简要总结
Patients undergoing rotator cuff repair surgery will experience improved tendon healing with the use of demineralized bone matrix augmentation.
详细描述
This is a prospective randomized study comparing the outcomes of patient undergoing rotator cuff repair with either an interpositional procedure administering demineralized bone matrix (DBM), or a control group without demineralized bone matrix. Patient outcomes will be collected and compared between the two cohorts up to a five (5) year post-operative period and will include a range of subjective and functional outcomes, along with radiographic imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Randomization shall be performed during surgery after intra-operative inclusion/exclusion eligibility has been met.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The Subject is between the ages of 40 and 75 years.
- •Subject is planning to undergo arthroscopic surgery for full thickness rotator cuff tears (RCT) of supraspinatus and infraspinatus muscles, who are candidates for demineralized bone matrix with BMC.
- •Two tendon tear or tear size equal to or greater than 3cm
- •Amenable to double-row repair
- •Primary rotator cuff tears with or without superior labral tear and/or biceps tear)
排除标准
- •The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board.
- •The Subject objects to use of allograft
- •Irreparable Rotator Cuff Tear
- •Complete full thickness subscapularis tears of > than the superior 1/3 of the tendon (Lafosse grade 3 and above)
- •< 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
- •Recurrent shoulder instability
- •Intra-articular injections (steroids) within 1 month of surgery
- •RCR revisions
- •Subject MRI taken more than 12 months prior to surgery
- •Pregnant or planning to become pregnant during the study period
- •Workman's compensation case
结局指标
主要结局
MRI
时间窗: 24 weeks
Rate of healing of the rotator cuff repair
次要结局
- American Shoulder and Elbow Surgeons Shoulder Score (ASES score)(pretreatment, 24 weeks, 1 year, 2 year and 5 year)
- Visual Analogue Scale (VAS)(pretreatment, 24 weeks, 1 year, 2 year and 5 year)
- Single Assessment Numerical Evaluation (SANE)(pretreatment, 24 weeks, 1 year, 2 year and 5 year)
- Veterans RAND Health (VR-12)(pretreatment, 24 weeks, 1 year, 2 year and 5 year)