Clinical trial NCT06918041: FiberLocker® System Augmentation of Rotator Cuff Repairs
Official title: FiberLocker® System Augmentation of Rotator Cuff Repairs
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rotator Cuff Tear
Rotator Cuff Tears
Rotator Cuff Tears of the Shoulder
Keywords: Rotator Cuff Tears
Rotator Cuff Repair
Augmentation
Reinforcement
Mechanical Augmentation
Rotator Cuff Degeneration
Lead sponsor: ZuriMED Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-09
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to prospectively evaluate healing, functional clinical outcomes, and safety of arthroscopic rotator cuff repairs augmented with the FiberLocker® System (encompassing the SpeedPatch® PET and the FiberLocker® Instrument SN).

The primary outcome measure is healing evaluation based on Magnetic Resonance Imaging (MRI) at a minimum of 6 months post-operatively.

The secondary outcome measures are the Sugaya classification, Goutallier Stage and tendon quality based on MRI as well as objective scores and patient-reported outcome measures (PROMs) from validated outcome scoring systems.


Eligibility criteria: Inclusion Criteria:

1. The Subject is between the ages of 30 and 70 years.
2. Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT)
3. Tear size ≥ 2 cm
4. Primary rotator cuff repair
5. Subject preoperative MRI obtained within 1 year prior to surgery

Exclusion Criteria:

1. The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board.
2. The Subject objects to the use of the FiberLocker® System
3. History or known allergy or intolerance to polyester
4. Complete full-thickness subscapularis tears of \> than the superior 1/3 of the tendon (Lafosse grade 3 and above)
5. Hamada grade III and above
6. Less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
7. Recurrent shoulder instability
8. Corticosteroid injection in the operative shoulder within three months before surgery
9. Subjects with inflammatory or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus)
10. Subjects with current acute infection in the area surrounding the surgical site
11. Revision rotator cuff repair
12. Pregnant or planning to become pregnant during the study period
13. Subject is breastfeeding during the study period
14. Subject has conditions or circumstances that would interfere with study requirements

Intraoperative Exclusion Criteria:

1. Partial rotator cuff repairs
2. Lafosse grade 3 or higher subscapularis tears
3. Limited space for implant delivery
4. FiberLocker® System cannot be used as indicated

Primary outcomes:
measure: Healing Evaluation
timeFrame: Pre-operatively & minimum 6 months post-operatively
Secondary outcomes:
measure: Sugaya Classification
timeFrame: Minimum 6 months post-operatively
measure: Goutallier Stage
timeFrame: Pre-operatively & minimum 6 months post-operatively
measure: Tendon Quality
timeFrame: Pre-operatively & minimum 6 months post-operatively
measure: American Shoulder and Elbow Surgeons (ASES) Score
timeFrame: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
measure: Single Assessment Numeric Evaluation (SANE) Score
timeFrame: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
measure: Visual Analog Scale for pain (VAS Score)
timeFrame: Pre-operatively, Post-operatively: 2 weeks, 6 months, 12 months, 24 months
measure: Veterans RAND 12-Item Health Survey (VR-12)
timeFrame: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
measure: Range of Motion (ROM) Assessment
timeFrame: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
measure: Strength Assessment
timeFrame: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
measure: Constant-Murley Score
timeFrame: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months (all optional)
measure: (Serious) Adverse Events, (Serious) Adverse Device Effects and Device Deficiencies
timeFrame: From the surgical intervention to 24 months postoperatively
Other outcomes:
Locations:
Study officials:
References: