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 range
18 Years – 80 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:
* 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…
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 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