SINEFIX-2022 Comparative Phase
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rotator cuff repair with the SINEFIX, Rotator cuff repair with comparator device.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Tears of the Shoulder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pre-market Clinical Investigation Inovedis SINEFIX
Overview
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, making the condition challenging to predictably treat in some patient populations. RCTs may occur in young people as a consequence of trauma (e.g. acute shoulder dislocation), however RCTs typically present in middle-aged or elderly people and cannot always be attributed to precipitating events or trauma. Instead, they can be attributed to degenerative processes, and are therefore referred to as degenerative RCTs. For RCTs, treatment options include both surgical and non-surgical (conservative) procedures. In this context, the SINEFIX implant and instruments were developed to treat adult patients with rotator cuff lesions of size up to 2 cm through arthroscopic reconstruction. A pilot study phase investigating the SINEFIX implant and instruments was conducted and showed adequate performance, usability and preliminary safety. Hence, the device is now being tested on a larger number of participants as part of the comparative study phase.
Interventions
- Device Rotator cuff repair with the SINEFIX
Treatment of rotator cuff lesions of size up to 2 cm using the SINEFIX implant and instruments - Device Rotator cuff repair with comparator device
Treatment of rotator cuff lesions with the conventional surgical technique (comparator device)
Primary outcome measures
- Functional and clinical outcome after rotator cuff repair as compared with baseline [Time frame: 1 year post operation]
Secondary outcome measures (12)
- Surgery time [Time frame: Immediately post procedure]
- Functional and clinical outcome after rotator cuff repair [Time frame: At 6 months, 1 and 2 years follow-up]
- Functional and clinical outcome after rotator cuff repair as compared with baseline [Time frame: At 6 months and 2 years follow-up]
- Shoulder function after rotator cuff repair (subjective evaluation) [Time frame: At 10 weeks, 6, 12, and 24 months]
- Shoulder function after rotator cuff repair (physical examination-active external rotation) [Time frame: At 10 weeks, 6, 12, and 24 months]
- Shoulder function after rotator cuff repair (physical examination-active anteversion) [Time frame: At 10 weeks, 6, 12, and 24 months]
- Healing integrity [Time frame: At 6, 12, and 24 months]
- Re-tear rate [Time frame: At 6, 12, and 24 months]
- Dislocation of the implant [Time frame: At 6, 12, and 24 months]
- Bursitis [Time frame: At 6, 12, and 24 months]
- Complications [Time frame: During the follow up time (up to 24 months)]
- Patient satisfaction [Time frame: At 10 weeks, 6, 12, 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Germany · 2 centers
- Kreiskrankenhaus Mechernich GmbH (KKHM) — Mechernich
- Orthopädisch Chirurgisches Centrum (OCC) — Tübingen
Identifiers
NCT: NCT06818448 · SINEFIX-2022 Comparative Phase