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Clinical Trial on the Effect of REGENETEN Bioinductive Implant in the Supraspinatus Tendon Repair

NCT04444076 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Supraspinatus Tear

Interventions

DEVICE

REGENETEN Bioinductive Implant

REGENETEN bioinductive Implant,a reconstituted bovine origin type I collagen mesh with a proprietary high porosity system that is commercialized sterile, dehydrated and desiccated in two sizes (20x26mm and 25x31mm). It will be implanted following supraspinatus tendon repair.

Sponsors & Collaborators

  • Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

    lead OTHER

Principal Investigators

  • Miguel Angel Ruiz Iban, MD, PhD · Hospital Ramón y Cajal, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-17
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04444076 on ClinicalTrials.gov