Expired Study
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Fort Lauderdale, Florida 33334


Purpose:

A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear (MRCT).


Study summary:

This is a non-inferiority, prospective, single blinded, multi-center, randomized, controlled, pivotal study evaluating the safety and effectiveness of the InSpace™ device as a primary surgical treatment for full thickness MRCT in comparison to Partial Repair of a full thickness MRCT performed during an arthroscopic procedure.


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.


NCT ID:

NCT02493660


Primary Contact:

Study Director
Assaf Dekel, MD
Ortho-Space


Backup Contact:

N/A


Location Contact:

Fort Lauderdale, Florida 33334
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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