Clinical trial NCT06818448: SINEFIX-2022 Comparative Phase
Official title: Pre-market Clinical Investigation Inovedis SINEFIX
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rotator Cuff Tears of the Shoulder
Lead sponsor: BAAT Medical Products B.V.
Sponsor class: INDUSTRY
First posted: 2025-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.


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

Primary outcomes:
measure: Functional and clinical outcome after rotator cuff repair as compared with baseline
timeFrame: 1 year post operation
Secondary outcomes:
measure: Surgery time
timeFrame: Immediately post procedure
measure: Functional and clinical outcome after rotator cuff repair
timeFrame: At 6 months, 1 and 2 years follow-up
measure: Functional and clinical outcome after rotator cuff repair as compared with baseline
timeFrame: At 6 months and 2 years follow-up
measure: Shoulder function after rotator cuff repair (subjective evaluation)
timeFrame: At 10 weeks, 6, 12, and 24 months
measure: Shoulder function after rotator cuff repair (physical examination-active external rotation)
timeFrame: At 10 weeks, 6, 12, and 24 months
measure: Shoulder function after rotator cuff repair (physical examination-active anteversion)
timeFrame: At 10 weeks, 6, 12, and 24 months
measure: Healing integrity
timeFrame: At 6, 12, and 24 months
measure: Re-tear rate
timeFrame: At 6, 12, and 24 months
measure: Dislocation of the implant
timeFrame: At 6, 12, and 24 months
measure: Bursitis
timeFrame: At 6, 12, and 24 months
measure: Complications
timeFrame: During the follow up time (up to 24 months)
measure: Patient satisfaction
timeFrame: At 10 weeks, 6, 12, 24 months
Other outcomes:
measure: Safety endpoint
timeFrame: During the intervention and the follow up time (up to 24 months)
Locations:
city: Mechernich
country: Germany
facility: Kreiskrankenhaus Mechernich GmbH (KKHM)
city: Tübingen
country: Germany
facility: Orthopädisch Chirurgisches Centrum (OCC)
Study officials:
References: