FiberLocker® System Augmentation of Rotator Cuff Repairs

ZuriMED Technologies Inc.60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rotator Cuff Tear Rotator Cuff Tears Rotator Cuff Tears of the Shoulder

Interventions

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Healing Evaluation

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).

Time frame: Pre-operatively & minimum 6 months post-operatively

Secondary Outcomes

Sugaya Classification

The Sugaya Classification based on MRI images is used to evaluate the integrity of a repaired rotator cuff and to assess healing outcomes after a repair. The classification uses a categorial scoring system with grades from Type I to Type V. - Type I: Normal thickness and low signal intensity in all sections * Type II: Normal thickness and high signal intensity * Type III: Insufficient thickness without discontinuity, representing a partial-thickness tear * Type IV: Minor discontinuity (1-2 slices) on both oblique coronal and oblique sagittal images * Type V: Major discontinuity (\>2 slices) on both oblique coronal and sagittal images

Time frame: Minimum 6 months post-operatively

Goutallier Stage

The Goutallier Classification is evaluated using MRI images to assess fatty infiltration and muscle degeneration in the rotator cuff. It has a categorial grading system from stage 0 to 4. Based on MRI images, the investigator classifies the rotator cuff of each subject. Thereby, a higher classification means more fatty infiltration.

Time frame: Pre-operatively & minimum 6 months post-operatively

Tendon Quality

The tendon quality of each subject is graded based on MRI images using a categorial scoring system. The following classification can be used: Normal, Intact with edema/regularity, Partial tearing and/or abnormal tissue, Complete Tear/Abnormal.

Time frame: Pre-operatively & minimum 6 months post-operatively

American Shoulder and Elbow Surgeons (ASES) Score

The ASES score is a patient-reported outcome measure survey which is completed by all subjects. It is used to assess shoulder function and pain. Based on the answers, a final score between 0 and 100 can be achieved. Thereby, higher scores indicate better shoulder function and less pain.