Clinical and Cost Effectiveness of Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 102
- 主要终点
- Western Ontario Rotator Cuff Index (WORC)
研究概览
简要总结
Randomized controlled trial comparing human dermal allograft with bovine collagen xenograft in rotator cuff repair.
详细描述
Randomized controlled trial comparing human dermal allograft with bovine collagen xenograft in rotator cuff repair.
Subjects will be randomized intraoperatively after confirmation of inclusion criteria.
Subjects will be followed-up at 3 weeks, 3 months, 6 months, 12 months and 24 months post-operatively.
Primary outcome is Western Ontario Rotator Cuff Index (WORC) at 12 months. Additional outcomes include American Shoulder and Elbow Surgeons questionnaire (ASES), Single Numeric Evaluation (SANE) score, EuroQoL (5 domains) score (a quality of life score), and Visual Analogue Scale, healing rate as determined by Magnetic Resonance Imaging (MRI) scan at 12 months post surgery. To determine the cost utility, data will be collected on the cumulative cost for the total episode of care up to 12 months post surgery inclusive of surgical costs, implant costs, outpatient costs, and medication costs. Quality-Adjusted Life Years (QALYs) gained will be calculated using the mean total cost and the quality of life score (EQ-5D) improvement from pre-operative to 12 months post 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)
盲法说明
Patients and research assistants collecting data will be unaware of the treatment assigned until the completion of the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •fully reparable full thickness rotator cuff tear whereby the treating surgeon feels a graft augment is needed to enhance healing
排除标准
- •tears where only a partial repair is achieved
- •significant glenohumeral joint arthropathy (Hamada grade 2 and above)
- •irreparable rotator cuff tears
- •patients unable or unwilling to consent or comply with study questionnaires
- •patients with upper limb neurological deficits affecting the ipsilateral limb
- •workers compensation cases
- •cases involving litigation
结局指标
主要结局
Western Ontario Rotator Cuff Index (WORC)
时间窗: 12 mos post-op
rotator cuff quality of life outcome questionnaire
次要结局
- Shoulder pain assessed by visual analog scale (VAS)(pre-op, 3mos, 6mos, 12mos, 24mos post-op)
- Western Ontario Rotator Cuff Index (WORC)(pre-op, 3 mos, 6 mos, 24 mos post-op)
- Anatomic healing(12mos post-op)
- Single Assessment Numeric Evaluation (SANE)(pre-op, 3mos, 6mos, 12mos, 24mos post-op)
- EuroQOL5D(pre-op, 3mos, 6mos, 12mos, 24mos post-op)