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
Stryker Endoscopy
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.
Description
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.
Eligibility
- Age range
- 65+ years
- Sex
- All
- Healthy volunteers
- Yes
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 trea…
Interventions
- DeviceInSpace Subacromial Tissue Spacer
Rotator Cuff Tear Treatment
Locations (11)
- Musculoskeletal-Orthopedic Research and Education FoundationPhoenix, Arizona
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- Steadman Hawkins Clinic DenverEnglewood, Colorado
- Holy Cross HospitalFort Lauderdale, Florida
- Paley Orthopaedics & SpineWest Palm Beach, Florida
- Emory UniversityAtlanta, Georgia