Status:
ACTIVE_NOT_RECRUITING
Clinical Trial on the Effect of REGENETEN Bioinductive Implant in the Supraspinatus Tendon Repair
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Conditions:
Supraspinatus Tear
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 g...
Detailed Description
The rotator cuff tear is one of the most frequent pathologies in the shoulder joint. When there are many symptoms these breaks are repaired surgically. The success rate of healing of these injuries is...
Eligibility Criteria
Inclusion
- 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
- 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 greater than 4 cm.
- SE and / or IE tendon ruptures that are considered irreparable or only partially repairable at the time of the intervention
- Presence of ruptures of the subscapularis and / or minor round tendons
- Presence of grade III or IV Goutallier atrophy in the supraspinatus muscle mass
- History of other orthopedic pathologies in the affected shoulder (previous shoulder surgeries, fractures, tendon re-ruptures of the supraspinatus or other tendons, rheumatic diseases, septic arthritis, ...)
Key Trial Info
Start Date :
June 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2026
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04444076
Start Date
June 17 2020
End Date
February 28 2026
Last Update
September 19 2024
Active Locations (1)
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1
Hospital Ramón y Cajal
Madrid, Spain, 28034