Defining a Randomised, Controlled Study of Ortho-ATI (Trademark) vs Corticosteroid Injection for Treatment of Rotator Cuff Tendinopathy and Tear.

Orthocell Ltd0 个研究点目标入组 30 人开始时间: 2017年5月12日最近更新: 2022年11月14日

适应症

试验速览

暂无简介。

•Participants must meet all of the following criteria:
•-Male or female between 30 and 65 years of age
•-Duration of symptoms > 6 months
•-Partial thickness, intra-substance supraspinatus tear without communication to the bursal or articular surface, that in the Investigator’s opinion, is of a sufficient size for treatment with Ortho-ATI (trademark), and is verified by MRI
•-Previously received one or more corticosteroid injections into the affected joint
•-Able to comply with the requirements of the protocol
•-Able to give informed consent or has legally acceptable representative who can give informed consent in accordance with ICH/GCP

•Corticosteroid or other treatment injection into the affected joint within 3 months of the first study visit.
•-Previous shoulder surgery or fracture on the affected side
•- Significant pathology of affected shoulder, that could, in the opinion of the Investigator, potentially compromise the outcome of treatment
•- Bilateral shoulder pathology
•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 could impair bone or soft tissue function
•-Professional athlete
•-Workers compensation or other 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 or comparator
•-Other clinically significant disease (including psychological disorders), medical condition or other factor that would, in the opinion of the Investigator, compromise the safety of the participant or the outcome of the study

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