Pre-market Clinical Investigation Inovedis SINEFIX
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rotator Cuff Tears (RCTs)
- Sponsor
- BAAT Medical Products B.V.
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Healing integrity
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
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 of supraspinatus, infraspinatus (medio-lateral)
- •Up to 2 cm tear size of supraspinatus, infraspinatus (anterior-posterior)
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
Outcomes
Primary Outcomes
Healing integrity
Time Frame: 3 months post operation
Healing integrity will be assessed with the MRI by evaluating the visibility of the tendon underneath the implant (yes/no)
Bursitis
Time Frame: 3 months post operation
Presence of bursitis will be assessed with MRI (yes/no)
Re-tear rate
Time Frame: 3 months post operation
Re-tear rate will be assessed with MRI
Dislocation of the implant
Time Frame: 3 months post operation
Presence of dislocation of the implant will be assessed with MRI (yes/no)
Secondary Outcomes
- Shoulder function after rotator cuff repair (subjective evaluation)(At 10 weeks, 6, 12, and 24 months)
- Functional and clinical outcome after rotator cuff repair as compared with baseline(At 6 months, 1 and 2 years follow-up)
- Bursitis(At 6, 12, and 24 months)
- Safety endpoint(During the intervention and the follow up time (up to 24 months))
- Surgery time(Immediately post procedure)
- Usability and workflow assessment(Immediately post procedure)
- Functional and clinical outcome after rotator cuff repair(At 6 months, 1 and 2 years follow-up)
- Shoulder function after rotator cuff repair (physical examination-active external rotation)(At 10 weeks, 6, 12, and 24 months)
- Shoulder function after rotator cuff repair (physical examination-active anteversion)(At 10 weeks, 6, 12, and 24 months)
- Healing integrity(At 6, 12, and 24 months)
- Complications(During the follow up time (up to 24 months))
- Patient satisfaction(At 10 weeks, 6, 12, 24 months)
- Re-tear rate(At 6, 12, and 24 months)
- Dislocation of the implant(At 6, 12, and 24 months)