SINEFIX-2022 Comparative Phase

NCT06818448 | Not Yet Recruiting

• 1 other identifier: SINEFIX-2022 Comparative Phase
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Functional and clinical outcome after rotator cuff repair as compared with baseline

  Functional and clinical outcome after rotator cuff repair will be assessed using the increase in total Constant Murley score at 1 year follow-up compared with baseline (range 0 (worst outcome) -100 (best outcome))

  1 year post operation

Secondary Outcomes (12)

• Surgery time

  Immediately post procedure

• Functional and clinical outcome after rotator cuff repair

  At 6 months, 1 and 2 years follow-up

• Functional and clinical outcome after rotator cuff repair as compared with baseline

  At 6 months and 2 years follow-up

• Shoulder function after rotator cuff repair (subjective evaluation)

  At 10 weeks, 6, 12, and 24 months

• Shoulder function after rotator cuff repair (physical examination-active external rotation)

  At 10 weeks, 6, 12, and 24 months

Other Outcomes (1)

• Safety endpoint

  During the intervention and the follow up time (up to 24 months)

Study Arms (2)

SINEFIX

EXPERIMENTAL

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

Device: Rotator cuff repair with the SINEFIX

Comparator

ACTIVE COMPARATOR

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

Device: Rotator cuff repair with comparator device

Interventions

Rotator cuff repair with the SINEFIX DEVICE

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

SINEFIX

Rotator cuff repair with comparator device DEVICE

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

Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BAAT Medical Products B.V.: lead

Study Sites (2)

Kreiskrankenhaus Mechernich GmbH (KKHM)

Mechernich, 53894, Germany

Location

Orthopädisch Chirurgisches Centrum (OCC)

Tübingen, 72074, Germany

Location

Central Study Contacts

Tess Van Dam

CONTACT

+31-(0)88-5656600; tess@baatmedical.com

Philip Kasten, Prof. Dr.

CONTACT

+49 (0) 7071 560 90; kasten@occ-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 10, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)