Acellular Dermis in Rotator Cuff Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- rotator cuff healing
研究概览
简要总结
To determine if an acellular dermal graft (ADG) will incorporate into the rotator cuff and subsequently improve outcomes without an increase in risk to the patient
详细描述
Rotator cuff healing poses a significant clinical problem with re-tear rates between 20-50%. The final functional outcome following surgery correlates with healing, with those that completely heal performing best. Failure of repair is mainly due to tendon failure both mechanically and biologically. If the healing and the structural properties of the tendon can be improved then significant functional gains may be achieved. This study will therefore utilise acellular dermal grafts to determine whether they could be used for to improve patient outcomes following surgery
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
- •Symptomatic rotator cuff tear that warrants operative intervention.
- •A Tear measuring between 1-5cm at arthroscopy.
- •An arthroscopic rotator cuff repair.
- •Written consent.
排除标准
- •Rotator cuff tears greater than 5cm and less than 1cm
- •Clinical or radiological evidence of osteoarthritis affecting the index side.
- •Patients involved in a Compensation claim related to the shoulder.
- •Inability to attend follow-up for 1 year and to a repeat MRI scan.
- •Previous shoulder surgery or proximal humeral fracture on the index side.
- •Patients that are recruited in a current study
结局指标
主要结局
rotator cuff healing
时间窗: 12 month post-surgery
Rotator cuff healing on MRI
次要结局
- Western Ontario Rotator cuff score(12months)
- Constant Murley score(12 months)
- American shoulder and elbow surgeons standardized form(12 months)