NCT03084068已完成不适用
A Prospective, Randomized Controlled Trial for Rotator Cuff Repair - Efficacy of Supraspinatus Tendon Repair Using a Human Dehydrated Umbilical Cord Patch
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- ASES score
研究概览
简要总结
To determine the effectiveness of human dehydrated umbilical cord allograft in standard open rotator cuff repair as assessed by the American Shoulder and Elbow Surgeons (ASES) score 12 months post-op.
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
- •MRI confirmed diagnosis of a full thickness supraspinatus tendon tear necessitating surgical intervention (rotator cuff repair)
- •Subject is male or female age 18 or older
- •Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
排除标准
- •Subjects who meet ANY of the following criteria will be excluded from the study:
- •Shoulder pain primarily attributed to any of the following:
- •Ligament rupture due to use of fluoroquinolones
- •Capsular tear
- •Fracture of the humeral head
- •Inflammation of the joint or surrounding tissue (i.e. osteoarthritis, bursitis)
- •Neuropathic, radiating pain from conditions resulting in damage or inflammation of the nerve
- •Previous history of autoimmune connective tissue disorders (i.e. rheumatoid arthritis, systemic lupus erythematosus)
- •Known history of poor compliance with medical treatments
- •Subject has bilateral supraspinatus tendon tear
- •Subject has signs and symptoms of an active infection of the shoulder joint
- •Retraction of the supraspinatus tendon exceeding 1.5 cm in length
- •Subject has additional injuries requiring further surgical intervention to the ipsilateral arm
- •Subject has had previous surgery in the target arm within the past 6 months prior to treatment or plans to have surgery other than Rotator Cuff Repair in the target arm within 180 days of treatment
- •Subjects currently receiving radiation therapy or chemotherapy
- •Subjects has used an investigational drug, device or biologic within 12 weeks prior to treatment
- •Subjects who are pregnant at enrollment or are planning to become pregnant within 180 days of treatment
- •Subject has any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
- •Allergy or known sensitivity to aminoglycoside antibiotics such as gentamicin sulfate and/or streptomycin sulfate
- •Workers' compensation patients
结局指标
主要结局
ASES score
时间窗: 12 months
The primary endpoint of the study is the number of subjects achieving a 20% increase from baseline in the overall ASES score at 12 months post-op.
次要结局
- Incidence of adverse events(12 months)
- Constant Murley Score(12 months)
- Shoulder range of motion(12 months)
- VAS Pain scores(12 months)
- Incidence of tendon re-tear(12 months)
研究者
研究点 (2)
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