Actively Recruiting
Pre-market Clinical Investigation of the Inovedis SINEFIX Implant for Rotator Cuff Tear Repair
Led by BAAT Medical Products B.V. · Updated on 2026-06-03
60
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Shoulder pain is a common problem that affects daily activities, work, sports, and independence. Rotator cuff disease is the main cause of shoulder pain and accounts for up to 70% of shoulder-related doctor visits. This condition includes various issues like tendinopathy, bursal problems, and rotator cuff tears (RCTs), which often happen due to trauma or degenerative changes, especially in middle-aged or older adults. The study focuses on adult patients with rotator cuff tears up to 2 cm in size to better understand and treat these injuries. The trial compares two surgical methods for repairing rotator cuff tears: using the SINEFIX implant and instruments versus a conventional surgical technique. The SINEFIX system was previously tested in a pilot study and is now being evaluated in a larger group. Participants will be randomly assigned to receive one of these two repair methods. Both treatments involve arthroscopic surgery aimed at reconstructing the rotator cuff. Participants will be followed for up to two years after surgery, with evaluations at multiple time points including 10 weeks, 6 months, 1 year, and 2 years. Researchers will assess shoulder function through physical exams and patient questionnaires, monitor healing and implant status using imaging, and record complications, re-tear rates, and patient satisfaction. The main outcome measured is the functional and clinical improvement one year after surgery compared to before the operation.
CONDITIONS
Brief Title
SINEFIX-2022 Comparative Phase
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient indicated for surgical repair of the rotator cuff tear according to current guidelines
- Patient aged 18 years or older
- Rotator cuff tear size up to 2 cm (medio-lateral) of supraspinatus or infraspinatus
- Rotator cuff tear size up to 2 cm (anterior-posterior) of supraspinatus or infraspinatus
You will not qualify if you...
- Previous rotator cuff, arthroplasty, or fracture surgery on the operative shoulder
- History of alcoholism, drug abuse, psychological or emotional problems interfering with study participation
- Presence of inflammatory arthropathies
- Contraindication or non-compliance with MRI examination
- Unwillingness to undergo surgical repair, post-operative rehabilitation, or adhere to follow-up schedule
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo rotator cuff repair surgery using either the SINEFIX implant or the conventional surgical technique.
1 visit (in-person)
Duration - Up to 24 months
Participants are monitored for healing, shoulder function, complications, and implant status after surgery.
Visits at 10 weeks, 6 months, 12 months, and 24 months (in-person)
Trial Site Locations
Total: 2 locations
1
Kreiskrankenhaus Mechernich GmbH (KKHM)
Mechernich, Germany, 53894
Actively Recruiting
2
Orthopädisch Chirurgisches Centrum (OCC)
Tübingen, Germany, 72074
Actively Recruiting
Research Team
T
Tess Van Dam
P
Philip Kasten, Prof. Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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