Study Objectives:~Primary:~• 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.~Secondary:~• Change in clinical outcomes compared to baseline.
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.