SINEFIX-2022 Pilot Phase

NCT05721560 | Active Not Recruiting

• 1 other identifier: SINEFIX-2022
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears (RCTs)

Outcome Measures

Primary Outcomes (4)

• Healing integrity

  Healing integrity will be assessed with the MRI by evaluating the visibility of the tendon underneath the implant (yes/no)

  3 months post operation

• Re-tear rate

  Re-tear rate will be assessed with MRI

  3 months post operation

• Dislocation of the implant

  Presence of dislocation of the implant will be assessed with MRI (yes/no)

  3 months post operation

• Bursitis

  Presence of bursitis will be assessed with MRI (yes/no)

  3 months post operation

Secondary Outcomes (14)

• Surgery time

  Immediately post procedure

• Usability and workflow assessment

  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, 1 and 2 years follow-up

• Shoulder function after rotator cuff repair (subjective evaluation)

  At 10 weeks, 6, 12, and 24 months

Study Arms (1)

SINEFIX

EXPERIMENTAL

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

Device: Rotator cuff repair with the SINEFIX

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

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 of supraspinatus, infraspinatus (medio-lateral)
• Up to 2 cm tear size of supraspinatus, infraspinatus (anterior-posterior)

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 (1)

Orthopädisch Chirurgisches Centrum (OCC)

Tübingen, 72074, Germany

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pilot phase: single-arm prospective non-comparative single-centre study phase

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 10, 2023
• Study Start: September 12, 2023
• Primary Completion: July 23, 2024
• Study Completion: April 1, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)