Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT02493660
Eligibility Criteria:
Main Inclusion Criteria:
* Positive diagnostic imaging by MRI of the index shoulder indicating a full thickness Massive Rotator Cuff Tear (MRCT), measuring ≥ 5 cm in diameter involving ≥ two tendons (confirmed Intra-operatively)
* Functional deltoid muscle and preserved passive range of motion on physical examination
* Documented VAS score of \> 30 mm pain
* Failed non-operative treatment of at least 4 months
* Patient in general good health,independent, and can comply with all post-operative evaluations and visits.
Main Exclusion Criteria:
* Known allergy to the device material (copolymer of PLA and -ε-caprolactone)
* Evidence of the following conditions:
1. significant gleno-humeral or acromiohumeral arthritis
2. full thickness cartilage loss as seen on MRI
3. gleno-humeral instability (excessive translation of the humeral head on the glenoid fossa)
4. pre-existing deltoid defect or deltoid palsy
5. major joint trauma, infection or necrosis
6. partial thickness tears of the supraspinatous
7. fully reparable rotator cuff tear \[Tear of less than 5 cm in diameter (or \< 4 cm2) with retractable tendon that can be fully repaired\]
* The subject requires concomitant subscapularis repair and/or labral repair
* Previous surgery of the index shoulder in the past 1 year, excluding diagnostic arthroscopy
* The subject's condition is bilateral and rotator cuff repair is scheduled or to be scheduled over the course of this study for the contra lateral shoulder
* Major medical condition that could affect quality of life and influence the results of the study (e.g. HIV or other immunosuppressive conditions, active malignancy in the past 5 years, acute MI, CVA, etc.)
* Documented evidence of a history of drug/alcohol abuse within 12 months of enrollment
* The subject's condition represents a worker's compensation case
* The subject is currently involved in a health-related litigation procedure
* Females of child-bearing potential who are pregnant or breastfeeding or plan to become pregnant during the course of the study
* Concurrent participation in any other investigational clinical study one month prior to enrollment or during the entire study period
* The subject has implanted metallic devices (e.g., cardiac pacemakers, insulin pumps, nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing a MRI scan or has claustrophobia that would inhibit ability to undergo a MRI scan .
* The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant to follow-up
* The subject is receiving prescription narcotic pain medication for conditions unrelated to the index shoulder condition
* The subject currently has an acute infection in the area surrounding the surgical site.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
100 Years
Study:
NCT02493660
Study Brief:
Protocol Section:
NCT02493660