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

NCT04444076 | Active Not Recruiting

• 1 other identifier: MALLAMANGUITO
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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 group study.

Conditions

Supraspinatus Tear

Keywords

Supraspinatus Tear; REGENETEN

Outcome Measures

Primary Outcomes (1)

• Integrity of the tendon repaired in an MRI study one year after the intervention using the Sugaya classification (Sugaya H (2005)).

  This is a classification system described by Sugaya et al. which uses magnetic resonance imaging in order to evaluate tendon integrity after rotator cuff repair. Postoperative cuff integrity is classified into 5 categories: type I, sufficient thickness with homogenously low intensity; type II, sufficient thickness with partial high intensity; type III, insufficient thickness without discontinuity; type IV, presence of minor discontinuity; type V, presence of major discontinuity

  12 months

Secondary Outcomes (5)

• Change in pain levels. Measured with questions 3 to 6 of the Brief Pain Inventory.

  3 months, 6 months and 12 months after surgery

• Functional changes, measured with the Constant-Murley Scale.

  3 months, 6 months and 12 months after surgery.

• Functional changes, measured with ASES questionnaire.

  3 months, 6 months and 12 months after surgery.

• Changes in quality of life measured with EQ-5D-5L questionnaire.

  3 months, 6 months and 12 months after surgery.

• Number of patients with complications in both arms

  12 months

Study Arms (2)

REGENETEN Bioinductive Implant

EXPERIMENTAL

REGENETEN bioinductive Implant,a bovine mesh that will be implanted following supraspinatus tendon repair.

Device: REGENETEN Bioinductive Implant

Standard of Care

NO INTERVENTION

Supraspinatus tendon repair.

Interventions

REGENETEN Bioinductive Implant DEVICE

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.

REGENETEN Bioinductive Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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, ...)

Sponsors & Collaborators

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

Study Sites (1)

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

Study Officials

• Miguel Angel Ruiz Iban, MD, PhD

  Hospital Ramón y Cajal, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 23, 2020
• Study Start: June 17, 2020
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)