SINEFIX-2022 Pilot Phase

Pre-market Clinical Investigation Inovedis SINEFIX

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tears (RCTs)
• Intervention / Treatment: Device: Rotator cuff repair with the SINEFIX

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tess van Dam, MSc; Phone Number: +31-(0)88-5656600; Email: tess@baatmedical.com
• Study Contact Backup: Name: Philip Kasten, Prof. Dr.; Phone Number: +49 (0) 7071 560 90; Email: kasten@occ-tuebingen.de

Study Locations

• Germany
  • Tübingen, Germany, 72074
    • Recruiting
    • Orthopädisch Chirurgisches Centrum (OCC)
    • Contact: Philip Kasten, Prof. Dr.; Phone Number: +49 (0) 7071 560 90; Email: kasten@occ-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: BAAT Medical Products B.V.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: SINEFIX-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No