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LifeNet: Extracellular Matrix Graft in Rotator Cuff Repair

NCT03551509 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-06-19

Study results available
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Summary

This trial is to evaluate the effectiveness of the ArthroFLEX® ECM scaffold graph as an augment in rotator cuff repair surgery to reduce the failure rate of rotator cuff repairs for large and massive rotator cuff tears.

Conditions

  • Rotator Cuff Tear

Interventions

PROCEDURE

ArthroFLEX ECM scaffold graft

In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.

PROCEDURE

Control

This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.

BIOLOGICAL

Alternative Treatment Group

Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.

Sponsors & Collaborators

  • LifeNet Health

    collaborator INDUSTRY

  • The Cleveland Clinic

    collaborator OTHER

  • Gregory Gilot

    lead OTHER

Principal Investigators

  • Gregory J Gilot, MD · Cleveland Clinic Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2024-06-30
Completion
2024-06-30
FDA Drug
Yes

Countries

  • United States

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 NCT03551509 on ClinicalTrials.gov