SINEFIX-2022 Comparative Phase

NCT ID: NCT06818448

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2028-03-31

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.

Conditions

Rotator Cuff Tears of the Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SINEFIX

Rotator cuff repair with the SINEFIX implant, using the SINEFIX instruments

Group Type: EXPERIMENTAL

Rotator cuff repair with the SINEFIX

Intervention Type: DEVICE

Treatment of rotator cuff lesions of size up to 2 cm using the SINEFIX implant and instruments

Comparator

Rotator cuff repair with the conventional surgical technique (comparator device)

Group Type: ACTIVE_COMPARATOR

Rotator cuff repair with comparator device

Intervention Type: DEVICE

Treatment of rotator cuff lesions with the conventional surgical technique (comparator device)

Interventions

Rotator cuff repair with the SINEFIX

Treatment of rotator cuff lesions of size up to 2 cm using the SINEFIX implant and instruments

Intervention Type: DEVICE

Rotator cuff repair with comparator device

Treatment of rotator cuff lesions with the conventional surgical technique (comparator device)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BAAT Medical Products B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kreiskrankenhaus Mechernich GmbH (KKHM)

Mechernich, , Germany

Orthopädisch Chirurgisches Centrum (OCC)

Tübingen, , Germany

Countries

Germany

Central Contacts

Tess Van Dam

Role: CONTACT

tess@baatmedical.com

+31-(0)88-5656600

Philip Kasten, Prof. Dr.

Role: CONTACT

kasten@occ-tuebingen.de

+49 (0) 7071 560 90

Facility Contacts

Anas Malkawi, MD

Role: primary

anas.malkawi@kkhm.de

+492443/17-1751

Philip Kasten, Prof. Dr.

Role: primary

kasten@occ-tuebingen.de

+49 (0) 7071 560 90

Other Identifiers

SINEFIX-2022 Comparative Phase

Identifier Type: -

Identifier Source: org_study_id