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NCT Number: NCT06818448

SINEFIX-2022 Comparative Phase

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.

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Key information

Conditions

Rotator Cuff Tears of the Shoulder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kreiskrankenhaus Mechernich GmbH (KKHM), Mechernich, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotator cuff repair with the SINEFIX

Device

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

Rotator cuff repair with comparator device

Device

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Surgery time

    Time frame: Immediately post procedure

    The total procedure duration will be recorded as the surgery time

  2. Functional and clinical outcome after rotator cuff repair

    Time frame: 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))

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

    Time frame: 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))

  4. Shoulder function after rotator cuff repair (subjective evaluation)

    Time frame: 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)

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

    Time frame: 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°)

  6. Shoulder function after rotator cuff repair (physical examination-active anteversion)

    Time frame: 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°)

  7. Healing integrity

    Time frame: 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)

  8. Re-tear rate

    Time frame: At 6, 12, and 24 months

    Re-tear rate will be assessed with MRI

  9. Dislocation of the implant

    Time frame: At 6, 12, and 24 months

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

  10. Bursitis

    Time frame: At 6, 12, and 24 months

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

  11. Complications

    Time frame: 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.

  12. Patient satisfaction

    Time frame: 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)

Other outcomes

  1. Safety endpoint

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

    Safety of the device will be evaluated by systematically reporting device deficiencies (DDs), adverse events (AEs) and serious adverse events (SAEs) and by monitoring the frequency and incidence of these events

Study contacts

Contact information is provided by the study sponsor or research team.

Philip Kasten, Prof. Dr.

CONTACT

[email protected]

+49 (0) 7071 560 90

Tess Van Dam

CONTACT

[email protected]

+31-(0)88-5656600

Sponsors and collaborators

Lead sponsor

BAAT Medical Products B.V.

Industry

Registry information

Official study title

Pre-market Clinical Investigation Inovedis SINEFIX

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 10, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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