a pivotal study to assess the inspace™ device for treatment of full thickness massive rotator cuff tears

Conditions: Rotator Cuff Syndrome

Summary: a pivotal study to assess the safety and effectiveness of the inspace™ device implantation in comparison to surgical partial repair of full thickness massive rotator cuff tear (mrct).

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.

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.

Keywords: massive rotator cuff tear arthroscopy shoulder joint rotator cuff partial repair