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 range65 Years
SexALL
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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…
What they're measuring
1
Change in American Shoulder and Elbow (ASES) Score