SINEFIX-2022 Comparative Phase

BAAT Medical

Status: Not yet enrolling

Conditions: Rotator Cuff Tears of the Shoulder

Treatments: Device: Rotator cuff repair with comparator device; Device: Rotator cuff repair with the SINEFIX

Study type: Interventional

Funder types: Industry

Identifiers

NCT06818448

SINEFIX-2022 Comparative Phase

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

SINEFIX

Experimental group

Description:

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

Treatment:

Device: Rotator cuff repair with the SINEFIX

Comparator

Active Comparator group

Description:

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

Treatment:

Device: Rotator cuff repair with comparator device