NCT06818448

SINEFIX-2022 Comparative Phase

Pre-market Clinical Investigation Inovedis SINEFIX

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: BAAT Medical Products B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rotator Cuff Tears of the Shoulder

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2025-02-10
• Last updated: 2025-02-10

Locations

2 sites across 1 country: Germany