Clinical Trial on the Effect of REGENETEN Bioinductive Implant in the Supraspinatus Tendon Repair (NCT04444076) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Trial on the Effect of REGENETEN Bioinductive Implant in the Supraspinatus Tendon Repair
Spain124 participantsStarted 2020-06-17
Plain-language summary
This study aims a determine the effect that the addition of REGENETEN Bioinductive Implant has on Supraspinatus Tendon Repair. 120 patients will be included in this prospective, randomized, parallel group study.
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:
* Patients who, after having received information about the design, the purposes of the study, the possible risks that may arise from it, and who may at any time deny their collaboration, give their written consent to participate in the study.
* \>18 years
* Patients who present:
* Symptomatic ruptures of the supraspinatus muscle (SE) with or without involvement of the infraspinatus (IE) with anteroposterior size of the rupture of 1 to 4 cm.
* With less than 3cm of retraction,
* With the absence of severe muscular atrophy confirmed by magnetic resonance imaging or CT (Absence of Goutalier grade I or II atrophy in muscle mass). MRI or CT must have been performed at most 6 months before the intervention.
* That it be confirmed during the exploratory arthroscopy at the beginning of the intervention.
* That after repair a coverage of the native footprint of the tendon of at least 80% is obtained
* No presence of rupture that requires repair in the tendons of the subscapularis muscles or minor round
* Understand the purpose of the study and be available for regular hospital visits.
* Negative urine pregnancy test performed in the 7 days prior to the start of study treatment in premenopausal women or \<2 years after menopause
Exclusion Criteria:
* Pregnancy or planning to become pregnant during the course of the study.
* SE tendon tears of more than 3cm retraction
* Tendon ruptures of the SE and IE muscles with anteroposterior size of the rupture g…
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
Integrity of the tendon repaired in an MRI study one year after the intervention using the Sugaya classification (Sugaya H (2005)).
Timeframe: 12 months
Trial details
NCT IDNCT04444076
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal