ACTRN12615001065583已完成未知
Pilot Study of CelGro(R) Collagen Scaffold to Augment Surgical Repair of Rotator Cuff Tendinopathy and Tear.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 40 Years 至 70 Years（—）
- 性别
- All
入选标准
- •* Male or female between 40 and 70 years of age
- •* Symptomatic full-thickness supraspinatus and/or
- •infraspinatus tear >2cm, verified by MRI or ultrasound
- •* Able to comply with the requirements of the protocol,
- •including the post-treatment rehabilitation protocol, (this is
- •standard of care).
- •* Able to give informed consent or has legally acceptable
- •representative who can give informed consent in accordance
- •with ICH/GCP
排除标准
- •* Evidence of clinically significant subchondral bone cyst
- •* Previous shoulder surgery or fracture
- •* Pathology of other rotator cuff or biceps tendons
- •* Glenohumeral or acromioclavicular osteoarthritis
- •* Evidence of calcification of affected tendon on screening MRI
- •* Active infection or systemic pathology including
- •inflammatory joint disease, HIV, uncontrolled or poorly
- •controlled diabetes, hepatitis or neoplastic disorders
- •* Neuromuscular disease of the affected arm
- •* Metabolic bone disorder which may impair bone or soft
- •tissue function
- •* Professional athlete
- •* Workers compensation case
- •* Known hypersensitivity to the study treatment or its
- •excipients or known relevant medication allergy
- •* Contraindicated to MRI
- •* Female participant who is pregnant or lactating
- •* Known substance abuse
- •* Participation in another study with an investigational
- •product within 3 months of the first planned study visit
- •* Concurrent medical condition which precludes the
- •administration of study treatment
- •* Other clinically significant disease (including psychological
- •disorders) or medical condition that would, in the opinion of
- •the Investigator, compromise the safety of the participant
- •or the outcome of the study
研究者
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