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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).
Full description
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.
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Inclusion and exclusion criteria
Main Inclusion Criteria:
Main Exclusion Criteria:
Known allergy to the device material (copolymer of PLA and -ε-caprolactone)
Evidence of the following conditions:
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.
Primary purpose
Allocation
Interventional model
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184 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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