InSpace Accelerated Rehabilitation Study (NCT05329584)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (21 items) and avoid the listed exclusions (38 items).
Location: Musculoskeletal-Orthopedic Research and Education Foundation โ Phoenix, Arizona
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: Subjects will be excluded from the study, if they meet ANY of the following individual exclusion criteria:
- Known allergy to the device material (copolymer of PLA (poly (lactic acid) and -ฮต-caprolactone)
- Evidence of the following conditions:
- Severe gleno-humeral or acromio-humeral arthritis
- Full thickness cartilage loss as seen on MRI
- History within the past 5 years of anterior or posterior shoulder subluxation or dislocation as determined by history, examination, or radiographic findings
- Pre-existing deltoid defect or deltoid palsy
- Major joint trauma, infection, or necrosis
- Partial thickness tears of the supraspinatus
- Fully reparable rotator cuff tear \[Tear of less than 5 cm in diameter (or \< 4 cm2) with retractable tendon that can be fully repaired\]
- Known neurovascular compromise
- Complete deltoid muscle palsy
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (11 Sites)
- Musculoskeletal-Orthopedic Research and Education Foundation โ Phoenix, Arizona
- University of Arkansas for Medical Sciences โ Little Rock, Arkansas
- Steadman Hawkins Clinic Denver โ Englewood, Colorado
- Holy Cross Hospital โ Fort Lauderdale, Florida
- Paley Orthopaedics & Spine โ West Palm Beach, Florida
- Emory University โ Atlanta, Georgia
- Rush University Medical Center โ Chicago, Illinois
- Mayo Clinic โ Rochester, Minnesota
- Hospital for Special Surgery โ New York, New York
- The Rothman Institute โ Philadelphia, Pennsylvania
- TSAOG Orthopaedics & Spine โ San Antonio, Texas
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.