LifeNet: Extracellular Matrix Graft in Rotator Cuff Repair

PHASE4TerminatedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

July 1, 2018

Primary Completion Date

June 30, 2024

Study Completion Date

June 30, 2024

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.

Trial Locations (1)

33331

Cleveland Clinic Florida, Weston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

LifeNet Health

INDUSTRY

collaborator

The Cleveland Clinic

OTHER

lead

Gregory Gilot

OTHER