Rotator Cuff Tear, Rotator Cuff Tears, Rotator Cuff Tears of the Shoulder
Conditions
Keywords
Rotator Cuff Tears, Rotator Cuff Repair, Augmentation, Reinforcement, Mechanical Augmentation, Rotator Cuff Degeneration
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.
Interventions
DEVICEFiberLocker® System (encompassing FiberLocker® Instrument & SpeedPatch® PET)
The 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.
Sponsors
ZuriMED Technologies Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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 15. The subject's condition represents a worker's compensation case Intraoperative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing Evaluation | 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
| Measure | Time frame | Description |
|---|---|---|
| Sugaya Classification | Minimum 6 months post-operatively | 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 |
| Goutallier Stage | Pre-operatively & minimum 6 months post-operatively | 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. |
| Tendon Quality | Pre-operatively & minimum 6 months post-operatively | 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. |
| American Shoulder and Elbow Surgeons (ASES) Score | Pre-operatively, Post-operatively: 6 months, 12 months, 24 months | 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. |
| Single Assessment Numeric Evaluation (SANE) Score | Pre-operatively, Post-operatively: 6 months, 12 months, 24 months | The SANE score is a patient-reported outcome measure used to assess a patient's perception of their shoulder function. It consists of a single question and each subject has to rate their shoulder function on a scale from 0% to 100%. Thereby, higher percentages indicates better shoulder function. |
| Visual Analog Scale for pain (VAS Score) | Pre-operatively, Post-operatively: 2 weeks, 6 months, 12 months, 24 months | The VAS Score is a patient-reported outcome measure used to assess pain intensity. All patients rate their pain on a horizontal line ranging from 0 to 10. Thereby, a higher score indicates greater pain intensity. |
| Veterans RAND 12-Item Health Survey (VR-12) | Pre-operatively, Post-operatively: 6 months, 12 months, 24 months | The VR-12 is a patient-reported outcome measure assessing physical and mental health of the subjects. Based on their answers, the subjects can reach a score between 0 and 100, with a higher score indicating better health. |
| Range of Motion (ROM) Assessment | Pre-operatively, Post-operatively: 6 months, 12 months, 24 months | The subject's active ROM (based on the objective ASES score) is assessed using a goniometer. During an outpatient visit at the investigators facility, forward flexion, external rotation, abducted external rotation, abducted internal rotation and internal rotation will be evaluated. The unit of measure is degrees. If subjects are unable to return for an in person visit, an optional self-assessment of these range of motion form will be provided for electronic completion. |
| Strength Assessment | Pre-operatively, Post-operatively: 6 months, 12 months, 24 months | The strength of each subject will be evaluated (based on objective ASES) using a manual muscle testing device or other dynamometers. Thereby, external rotation strength, subscapularis strength-belly press and the constant score strength will be evaulated. The unit of measure will be kilograms or pounds. |
| Constant-Murley Score | Pre-operatively, Post-operatively: 6 months, 12 months, 24 months (all optional) | The Constant-Murley Score will be assessed optionally. The score requires an outpatient visit at the investigator's facility and covers questions and functional assessments to assess pain, activity levels, range of motion and strength. The range of motion is assessed using a goniometer in degrees and the strength using a manual muscle testing device (or other dynamometers) in kilogram. The subjects can reach points between 0 and 100, whereby a higher score indicates better function. |
| (Serious) Adverse Events, (Serious) Adverse Device Effects and Device Deficiencies | From the surgical intervention to 24 months postoperatively | (Serious) Adverse Events, (Serious) Adverse Device Effects and Device Deficiencies will be reported by the research staff as soon as they occur. |
Countries
United States
Outcome results
None listed