InSpace Accelerated Rehabilitation Study (NCT05329584) | Clinical Trial Compass
RecruitingNot Applicable
InSpace Accelerated Rehabilitation Study
United States160 participantsStarted 2022-02-07
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 the Investigator) based on screening assessments and medical history
* Must be independent, ambulatory, and can comply with all post-operative evaluations, visits, and electronic database collection
Intra-operative Inclusion Criteria
Subjects MUST meet the following criteria to be randomized in the study:
* Full thickness tear
* Tear size ≥ 5 cm in diameter
* Tear involving ≥ two tendons
Exclusion Criteria:
Subjects will be excluded from the study, if they meet ANY of t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in American Shoulder and Elbow (ASES) Score