SINEFIX-2022 Pilot Phase

Study Overview
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Brief Summary
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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.

Official Title
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Pre-market Clinical Investigation Inovedis SINEFIX

Conditions
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Rotator Cuff Tears (RCTs)

Intervention / Treatment
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* Device: Rotator cuff repair with the SINEFIX


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot phase: single-arm prospective non-comparative single-centre study phase
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SINEFIX<br>Rotator cuff repair with the SINEFIX implant, using the SINEFIX instruments | Device: Rotator cuff repair with the SINEFIX<br>* Treatment of rotator cuff lesions of size up to 2 cm using the SINEFIX implant and instruments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery time | The total procedure duration will be recorded as the surgery time | Immediately post procedure | 
| Usability and workflow assessment | Usability and workflow assessment will be evaluated after each intervention through a practitioner's questionnaire covering different aspects of the implant and instruments | Immediately post procedure | 
| Functional and clinical outcome after rotator cuff repair | Functional and clinical outcome after rotator cuff repair will be assessed using the total Constant Murley score, which ranges from 0 (worst outcome) to 100 (best outcome) | At 6 months, 1 and 2 years follow-up | 
| 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 change of the total Constant Murley score (range 0-100) as compared to baseline | At 6 months, 1 and 2 years follow-up | 
| Shoulder function after rotator cuff repair (subjective evaluation) | Shoulder function after rotator cuff repair (subjective evaluation) will be assessed through the Subjective Shoulder Value (SSV) which ranges from 0% to 100% (best outcome) | At 10 weeks, 6, 12, and 24 months | 
| Shoulder function after rotator cuff repair (physical examination-active external rotation) | 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°) | At 10 weeks, 6, 12, and 24 months | 
| Shoulder function after rotator cuff repair (physical examination-active anteversion) | 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°) | At 10 weeks, 6, 12, and 24 months | 
| Healing integrity | Healing integrity will be assessed with the MRI by evaluating the visibility of the tendon underneath the implant (yes/no) | At 6, 12, and 24 months | 
| Re-tear rate | Re-tear rate will be assessed with MRI | At 6, 12, and 24 months | 
| Dislocation of the implant | Presence of dislocation will be assessed with MRI (yes/no) | At 6, 12, and 24 months | 
| Bursitis | Presence of bursitis will be assessed with MRI (yes/no) | At 6, 12, and 24 months | 
| Complications | 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. | During the follow up time (up to 24 months) | 
| Patient satisfaction | 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) | At 10 weeks, 6, 12, 24 months | 
| Safety endpoint | 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 | During the intervention and the follow up time (up to 24 months) |