Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a prospective, parallel group, open-label, multi- center, randomized study to assess two accelerated rehabilitation programs for use with the InSpace device in the treatment of full thickness Massive, Irreparable Rotator Cuff Tears (MIRCTs) performed during an arthroscopic procedure.
Eligibility Criteria
Inclusion Criteria: Subjects MUST meet ALL the following criteria to be included in the study: * The subject has signed the IRB approved Informed Consent Form (ICF) specific to this study prior to enrollment * Is male or female ≥ sixty-five (65) years of age * Positive diagnostic imaging by MRI within 9 months of enrollment of the index shoulder indicating a full thickness MRCT: * Measuring ≥ 5 cm in diameter * Involving ≥ two tendons * Functional deltoid muscle and preserved passive range of motion on physical examination * Documented VAS score \> 30 mm pain * Failed non-operative treatment of at least 3 months from the initial treatment to include one or more of the following: * Oral analgesics * Anti-inflammatory medication (e.g., ibuprofen, naproxen) * Corticosteroid injection(s) * Physical therapy * Activity modification * Rest (sling used) * Must be able to read and understand the approved Informed Consent Form (written and oral) * Must be in general good health (as determined by