Difference in pain and functional outcome after arthroscopic debridement vs. debridement and biodegradable implanted balloon for irreparable rotator cuff tears. - Debridement vs debridement and biodegradable balloon

Reinier Haga Orthopedisch Centrum0 个研究点目标入组 104 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•-Subject is not able to complete the daily questionnaires in Dutch.
•-Subject, in the opinion of the investigator, is not able to understand this
•investigation and is not willing and able to perform all study procedures and
•co-operate with investigational procedures.
•-Subject has glenohumeral osteo-arthrosis grade 3 and 4 (KELLGREN and LAWRENCE
•494-502).
•-Subject has a total subscalpularis tendon tear.
•-Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in
•the last 5 years) or has a psychological disorder that could affect their
•ability to complete subject reported questionnaires or be compliant with
•follow-up requirements
•-Subject was diagnosed and is taking prescription medications to treat a
•muscular disorder that limits mobility due to severe stiffness and pain such as
•fibromyalgia or polymyalgia.
•- Subject has an active elevation of less than 60 degrees (pseudoparalysis).
•-Subject has participated in a clinical investigation with an investigational
•product (drug or device) in the last three months.
•- Subject is allergic to the Balloon material
•-Subject has a medical condition with less than 3 years of life expectancy.
•.-Subject has refused voluntary, written informed consent to participate in
•this randomized controlled trial.

发起方

Reinier Haga Orthopedisch Centrum