FiberLocker® System Augmentation of Rotator Cuff Repairs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorZuriMED Technologies Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
FiberLocker® System (encompassing FiberLocker® Instrument & SpeedPatch® PET)
DeviceThe FiberLocker® System is a mechanical augmentation system that includes an implant (SpeedPatch® PET) and an instrument (FiberLocker® Instrument) for its attachment. The implant is composed of non-woven PET fibers, and the instrument features a reciprocating needle at its tip, which pushes the individual patch fibers into the underlying tendon tissue.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Augmentation of Rotator Cuff Repair using the FiberLocker® SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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-operativelySecondary outcomes
1
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-operatively2
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-operatively3
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-operatively4
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.
Time frame
Pre-operatively, Post-operatively: 6 months, 12 months, 24 monthsSponsors and contacts
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Source ClinicalTrials.gov