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 range18 Years
SexALL
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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…
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