FiberLocker® System Augmentation of Rotator Cuff Repairs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Healing Evaluation
Study Overview
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).
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The Subject is between the ages of 30 and 70 years.
- •Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT)
- •Tear size ≥ 2 cm
- •Primary rotator cuff repair
- •Subject preoperative MRI obtained within 1 year prior to surgery
Exclusion Criteria
- •The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board.
- •The Subject objects to the use of the FiberLocker® System
- •History or known allergy or intolerance to polyester
- •Complete full-thickness subscapularis tears of > than the superior 1/3 of the tendon (Lafosse grade 3 and above)
- •Hamada grade III and above
- •Less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
- •Recurrent shoulder instability
- •Corticosteroid injection in the operative shoulder within three months before surgery
- •Subjects with inflammatory or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus)
- •Subjects with current acute infection in the area surrounding the surgical site
- •Revision rotator cuff repair
- •Pregnant or planning to become pregnant during the study period
- •Subject is breastfeeding during the study period
- •Subject has conditions or circumstances that would interfere with study requirements
- •The subject's condition represents a worker's compensation case
- •Intraoperative Exclusion Criteria:
- •Partial rotator cuff repairs
- •Lafosse grade 3 or higher subscapularis tears
- •Limited space for implant delivery
- •FiberLocker® System cannot be used as indicated
Arms & Interventions
Augmentation of Rotator Cuff Repair using the FiberLocker® System
All enrolled participants will undergo repair of the rotator cuff tear, with augmentation utilizing the FiberLocker® System.
Intervention: FiberLocker® System (encompassing FiberLocker® Instrument & SpeedPatch® PET) (Device)
Outcomes
Primary Outcomes
Healing Evaluation
Time Frame: Pre-operatively & minimum 6 months post-operatively
The primary outcome measure is healing evaluation based on Magnetic Resonance Imaging (MRI) at a minimum of 6 months post-operatively. A standard shoulder MRI protocol utilizing a minimum of a 1.5 Tesla magnet will be utilized. The cuff integrity will be classified using the 5 categories described by Sugaya et al. Thereby, type IV and V are considered as retear and type I, II, and III as healed. The healing rate will be estimated and reported descriptively, and a 95% confidence interval will be reported assuming a binomial distribution (unless otherwise noted).
Secondary Outcomes
- Sugaya Classification(Minimum 6 months post-operatively)
- Tendon Quality(Pre-operatively & minimum 6 months post-operatively)
- Veterans RAND 12-Item Health Survey (VR-12)(Pre-operatively, Post-operatively: 6 months, 12 months, 24 months)
- Range of Motion (ROM) Assessment(Pre-operatively, Post-operatively: 6 months, 12 months, 24 months)
- Constant-Murley Score(Pre-operatively, Post-operatively: 6 months, 12 months, 24 months (all optional))
- (Serious) Adverse Events, (Serious) Adverse Device Effects and Device Deficiencies(From the surgical intervention to 24 months postoperatively)
- Goutallier Stage(Pre-operatively & minimum 6 months post-operatively)
- American Shoulder and Elbow Surgeons (ASES) Score(Pre-operatively, Post-operatively: 6 months, 12 months, 24 months)
- Visual Analog Scale for pain (VAS Score)(Pre-operatively, Post-operatively: 2 weeks, 6 months, 12 months, 24 months)
- Strength Assessment(Pre-operatively, Post-operatively: 6 months, 12 months, 24 months)
- Single Assessment Numeric Evaluation (SANE) Score(Pre-operatively, Post-operatively: 6 months, 12 months, 24 months)