Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears (NCT05444465) | Clinical Trial Compass
RecruitingNot Applicable
Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears
United States, Australia, Canada234 participantsStarted 2022-08-30
Plain-language summary
The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.
Who can participate
Age range
18 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:
* The subject must provide written informed consent.
* Subject is \> eighteen (18) years of age (no upper limit).
* Subject has an isolated high-grade (\>50% or \>6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus.
* Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear.
* Subject willing and able to make all required study visits.
* Subject able to follow instructions and deemed capable of completing all study questionnaires.
Exclusion Criteria:
* Subjects with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant system.
* Subjects where the prescribed Physical Therapy guidelines stated in the protocol are not suitable for their rehabilitation.
* Subjects with Samilson-Prieto osteoarthritis grade 2 and greater.
* Subjects with current or prior infection of the ipsilateral shoulder.
* Subjects with known hypersensitivity to bovine-derived materials.
* Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, chronic joint disease or chronic pain of upper extremities (shoulder(s), arm(s)).
* Subjects with prior shoulder surgery on index shoulder, including subacromial decompression, biceps tenodesis/tenotomy, and acromioclavicular joint (ACJ) excision/distal clavicle excision (DCE).
* Subjects with a planned surgery on the contra-late…
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 Western Ontario Rotator Cuff (WORC)
Timeframe: Change from baseline to 3 months post-intervention