CONDITION TREATED: Rotator Cuff Tears
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.
Status: Actively Enrolling New Study Participants
Site Principal Investigator: Michael Amini, MD
Clinical Study Partner: The CORE Institute
- To evaluate clinical outcomes of both a formalized or an at-home rehabilitation program when used in conjunction with the InSpace device as compared to the corresponding InSpace Pivotal study results.
- To demonstrate consistency of each intervention group with the corresponding historical control study results.
- To demonstrate that comparable clinical outcomes can be achieved for each intervention group.
- Change in clinical outcomes compared to baseline (secondary outcome)
OFFICIAL TITLE: An Assessment of Two Accelerated Rehabilitation Programs for Use With the InSpaceTM Subacromial Tissue Spacer System in the Treatment of Full-thickness Massive, Irreparable Rotator Cuff Tears
INTERVENTION / TREATMENT
Device: InSpace Subacromial Tissue Spacer
Link to Clinicaltrials.gov listing: https://clinicaltrials.gov/study/NCT05329584