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SINEFIX-2022 Comparative Phase

RecruitingNAAges 18 Years - anyAllBAAT Medical Products B.V.
NCT06818448 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Shoulder pain is one of the most commonly reported musculoskeletal complaints, which negatively affects upper limb use, night rest, daily life activities, work, sports performance and autonomy. Rotator cuff disease represents the most common cause of shoulder pain and it is responsible for up to 70% of all shoulder related visits to clinicians. Its incidence furthermore is expected to grow as the population ages. A wide range of conditions are included under the umbrella term of rotator cuff disease, including rotator cuff tendinopathy, subacromial bursal pathology, and partial-thickness or full- thickness rotator cuff tears (RCTs). The latter ones, i.e. rotator cuff tears, form the indications for which the test devices, the SINEFIX implant and instruments, are intended. Despite the high prevalence of this condition, the pathophysiology and healing potential are not well understood, ma

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📋 Eligibility rules (as published)
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
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What it tests

  • Rotator cuff repair with the SINEFIX
  • Rotator cuff repair with comparator device
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Where

2 sites
Kreiskrankenhaus Mechernich GmbH (KKHM)
Mechernich, Germany
Orthopädisch Chirurgisches Centrum (OCC)
Tübingen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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