Rotator Cuff Study--For Those Who Require Surgical Treatment for Full Thickness Massive Tear
Purpose
This research study will evaluate a new device, InSpace, for use with a full thickness massive tear of rotator cuff (the group of connective tissues in the shoulder). The device is designed to allow smooth gliding of the bones in the shoulder during motion, which may allow rehabilitation exercises with less pain. The research study is being conducted to see whether the InSpace device is safe and effective for shoulder problems due to a full thickness massive rotator cuff tear.
Could this study be right for you?
1) Is male or female ≥ forty (40) years of age
2) Positive diagnostic imaging by MRI within 9 months of enrollment of the index shoulder indicating a full thickness MRCT: measuring ≥ 5 cm in diameter (Cofield classification) and involving ≥ two tendons
3) Functional deltoid muscle and preserved passive range of motion on physical examination
4) Failed non-operative treatment of at least 4 months from the initial treatment to include one or all of the following: Oral analgesics, Anti-inflammatory medication (e.g., ibuprofen, naproxen), Corticosteroid injection(s), Physical therapy, Activity modification, or Rest (sling used)
5) Must be able to read and understand the approved Informed Consent Form (written and oral)
6) Must be in general good health (as determined by the Investigator) based on screening assessments and medical history
7) Must be independent, ambulatory, and can comply with all post-operative evaluations and visits.
Other details will be shared by the study coordinator.