SINEFIX-2022 Comparative Phase

Not Applicable

Not yet recruiting

• Conditions: Rotator Cuff Tears of the Shoulder

• Registration Number: NCT06818448
• Lead Sponsor: BAAT Medical Products B.V.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Study Start: 2025-03
• Primary Completion: 2027-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional and clinical outcome after rotator cuff repair as compared with baseline	1 year post operation	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))

Secondary Outcome Measures

Name	Time	Method
Re-tear rate	At 6, 12, and 24 months	Re-tear rate will be assessed with MRI
Patient satisfaction	At 10 weeks, 6, 12, 24 months	The patient will be asked to rate his/her satisfaction with outcome of the surgical repair (0=completely unsatisfied, 1=unsatisfied, 2=satisfied, 3=completely satisfied)
Healing integrity	At 6, 12, and 24 months	Healing integrity will be assessed with the MRI by evaluating the visibility of the tendon underneath the implant (yes/ no)
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 will be assessed using the total Constant Murley score at 6 months, 1 and 2 years follow-up (range 0 (worst outcome) -100 (best outcome))
Functional and clinical outcome after rotator cuff repair as compared with baseline	At 6 months and 2 years follow-up	Functional and clinical outcome after rotator cuff repair will be assessed using the increase in total Constant Murley score at 6 months and 2 years compared with baseline (range 0 (worst outcome) - 100 (best outcome))
Shoulder function after rotator cuff repair (subjective evaluation)	At 10 weeks, 6, 12, and 24 months	Shoulder function after rotator cuff repair will be assessed through the Subjective Shoulder Value (SSV) which ranges from 0% to 100% (best outcome)
Surgery time	Immediately post procedure	The total procedure duration will be recorded as the surgery time
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) will be assessed through a physical examination with assessment of range of motion for active external rotation (range 0°-90°)
Dislocation of the implant	At 6, 12, and 24 months	Presence of dislocation will be assessed with MRI (yes/no)
Bursitis	At 6, 12, and 24 months	Presence of bursitis will be assessed with MRI (yes/no)
Shoulder function after rotator cuff repair (physical examination-active anteversion)	At 10 weeks, 6, 12, and 24 months	Shoulder function after rotator cuff repair (physical examination) will be assessed through a physical examination with assessment of range of motion for active anteversion (0°-180°)
Complications	During the follow up time (up to 24 months)	Complications will be systematically reported. Complications of particular interest for the purpose of the study are neurological problems, bleeding, impaired wound healing, infection and frozen shoulder.

Trial Locations

Locations (2)

Kreiskrankenhaus Mechernich GmbH (KKHM); 🇩🇪 Mechernich, Germany

Orthopädisch Chirurgisches Centrum (OCC); 🇩🇪 Tübingen, Germany