Rotator cuff repair with SINEFIX vs a comparator device in adults with small tears

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with rotator cuff tears up to 2 cm undergoing surgical repair are randomized to receive the SINEFIX implant or a comparator device. The study focuses on safety and healing outcomes after repair, including pain, shoulder function, and recovery milestones. Procedures include standard surgical repair and postoperative rehabilitation, with follow-up assessments as part of routine care. The trial aims to determine if SINEFIX offers advantages in healing and function compared with the standard approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient indicated for surgical repair of the rotator cuff tear according to current guidelines
* Patient aged 18 years or older
* Up to 2 cm tear size (medio-lateral) of supraspinatus, infraspinatus
* Up to 2 cm tear size (anterior-posterior) of supraspinatus, infraspinatus

Exclusion Criteria:

* Subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder
* History of alcoholism, drug abuse, psychological or other emotional problems likely to interfere with participation in the study follow-up schedule and assessments
* Inflammatory arthropathies
* Subject with a contraindication/non-compliance for MRI examination
* Subject 's unwillingness to undergo surgical rotator cuff repair, participate in post-operative rehabilitation program, and / or adhere to follow up schedule
* Pregnant and breastfeeding woman

Where it's running

• Kreiskrankenhaus Mechernich GmbH (KKHM)
  Mechernich, Germany Recruiting
• Orthopädisch Chirurgisches Centrum (OCC)
  Tübingen, Germany Recruiting

Study contacts

• Study coordinator: Tess Van Dam
• Email: tess@baatmedical.com
• Phone: +31-(0)88-5656600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.