Prospective Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft Acti… (NCT05894265) | Clinical Trial Compass
RecruitingNot Applicable
Prospective Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft Active Matrix (AM) vs. Standard of Care in Arthroscopic Rotator Cuff Repair
United States72 participantsStarted 2023-06-14
Plain-language summary
The purpose of this study is to see how well the ActiveMatrix® graft works at improving healing and function of the shoulder following rotator cuff repair surgery
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* 1-2 tendon full thickness reparable rotator cuff tendon tear(s)
Reparable tear defined as:
a tear of the rotator cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus under minimal tension.
Full-thickness tear defined as:
a tear that involves the majority of supraspinatus and less than half of the infraspinatus under minimal tension, with no subscapularis involvement beyond the upper border
* Failed conservative medical management of the rotator cuff tendon tear defined as: 4-6 weeks of formal physical therapy or guided home exercises and activity modification
* Have no contraindications or allergies to the treatment administered
* Have current imaging studies (plain radiographs and MRI exams) of the shoulder to rule out other etiologic diagnoses
* Able and willing to comply with the post-operative physical therapy and study follow-up schedule
Exclusion Criteria:
* Prior surgery on the index shoulder within 12 months of enrollment, including Latarjet procedures, superior labral treat from anterior to posterior (SLAP), and (failed) primary rotator cuff surgery,
* Prior surgery for bone defects requiring bone implantation in the index shoulder,
* Steroid injection into the index shoulder within 6 weeks of enrollment.
* Subscapularis tear gre…
What they're measuring
1
Change in Sugaya score as measured by Magnetic Resonance Imaging (MRI)
Timeframe: 6 months post surgery , 12 months post surgery
Trial details
NCT IDNCT05894265
SponsorThe University of Texas Health Science Center, Houston