LifeNet: Extracellular Matrix Graft in Rotator Cuff Repair

NCT03551509 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: FLA 18-008
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Rotator Cuff Tear; Large Rotator Cuff Tear; Massive Rotator Cuff Tear; ECM; Extracellular Matrix; ArthroFLEX

Outcome Measures

Primary Outcomes (6)

• Tendon Healing

  Success as defined by tendon healing after rotator cuff repair, as indicated based on MRI

  As assessed 1 year postoperatively.

• Comparison of Healing by MRI vs US

  Comparison of tendon healing will be assessed using US imaging modalities versus MRI (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)

  As assessed 1 year postoperatively.

• Progress of Tendon Healing

  Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)

  As assessed at 6 weeks postoperatively.

• Progress of Tendon Healing

  Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)

  As assessed at 3 months postoperatively.

• Progress of Tendon Healing

  Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)

  As assessed at 6 months postoperatively.

• Progress of Tendon Healing

  Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)

  As assessed at 9 months postoperatively.

Secondary Outcomes (42)

• Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)

  Preoperative

• Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)

  6 weeks after surgery

• Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)

  3 months after surgery

• Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)

  6 months after surgery

• Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)

  9 months after surgery

Study Arms (3)

Control Treatment Group

ACTIVE COMPARATOR

Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used.

Procedure: Control

Treatment Group

ACTIVE COMPARATOR

Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff.

Procedure: ArthroFLEX ECM scaffold graft

Alternative Treatment Group

OTHER

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.

Biological: Alternative Treatment Group

Interventions

ArthroFLEX ECM scaffold graft PROCEDURE

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.

Also known as: Surgery with ECM graft

Treatment Group

Control PROCEDURE

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

Also known as: Surgery without ECM graft

Control Treatment Group

Alternative Treatment Group BIOLOGICAL

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.

Also known as: Repair cannot be accomplished

Alternative Treatment Group

Eligibility Criteria

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

You may qualify if:

• Patients with a large (2.5-5 cm) to massive (\>5 cm) rotator cuff tear who will be undergoing open or arthroscopic repair. The cuff tear size will be determined on either pre-operative magnetic resonance imaging (MRI), or ultrasound (US), or intra-operative measurements, or computerized tomography (CT).
• Patients who are willing and able to provide written informed consent for their involvement in the study.
• Patients who meet criteria for RCR surgery
• Patients older than 18 years of age

You may not qualify if:

• Those with a known sensitivity to materials of porcine origin.
• Patients with addiction to illegal drugs, solvents or alcohol who are actively using or have previously attempted and failed a treatment program.
• Patients with bacteremia, a systemic infection, or infection of the surgical site.
• All those who are prisoners.
• Patients who are pregnant or nursing.
• All those with a condition that may limit a patient's ability to finalize the study or that may cause an undue risk to the patient's health and well-being.

Sponsors & Collaborators

• Gregory Gilot: lead
• LifeNet Health: collaborator
• The Cleveland Clinic: collaborator

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Related Publications (14)

• Derwin KA, Badylak SF, Steinmann SP, Iannotti JP. Extracellular matrix scaffold devices for rotator cuff repair. J Shoulder Elbow Surg. 2010 Apr;19(3):467-76. doi: 10.1016/j.jse.2009.10.020. Epub 2010 Feb 26.

  PMID: 20189415 BACKGROUND

• Schlegel TF, Hawkins RJ, Lewis CW, Motta T, Turner AS. The effects of augmentation with Swine small intestine submucosa on tendon healing under tension: histologic and mechanical evaluations in sheep. Am J Sports Med. 2006 Feb;34(2):275-80. doi: 10.1177/0363546505279912. Epub 2005 Oct 6.

  PMID: 16210577 BACKGROUND

• Badylak SF, Freytes DO, Gilbert TW. Extracellular matrix as a biological scaffold material: Structure and function. Acta Biomater. 2009 Jan;5(1):1-13. doi: 10.1016/j.actbio.2008.09.013. Epub 2008 Oct 2.

  PMID: 18938117 BACKGROUND

• Sclamberg SG, Tibone JE, Itamura JM, Kasraeian S. Six-month magnetic resonance imaging follow-up of large and massive rotator cuff repairs reinforced with porcine small intestinal submucosa. J Shoulder Elbow Surg. 2004 Sep-Oct;13(5):538-41. doi: 10.1016/j.jse.2004.03.005.

  PMID: 15383811 BACKGROUND

• Iannotti JP, Codsi MJ, Kwon YW, Derwin K, Ciccone J, Brems JJ. Porcine small intestine submucosa augmentation of surgical repair of chronic two-tendon rotator cuff tears. A randomized, controlled trial. J Bone Joint Surg Am. 2006 Jun;88(6):1238-44. doi: 10.2106/JBJS.E.00524.

  PMID: 16757756 BACKGROUND

• Walton JR, Bowman NK, Khatib Y, Linklater J, Murrell GA. Restore orthobiologic implant: not recommended for augmentation of rotator cuff repairs. J Bone Joint Surg Am. 2007 Apr;89(4):786-91. doi: 10.2106/JBJS.F.00315.

  PMID: 17403801 BACKGROUND

• Zheng MH, Chen J, Kirilak Y, Willers C, Xu J, Wood D. Porcine small intestine submucosa (SIS) is not an acellular collagenous matrix and contains porcine DNA: possible implications in human implantation. J Biomed Mater Res B Appl Biomater. 2005 Apr;73(1):61-7. doi: 10.1002/jbm.b.30170.

  PMID: 15736287 BACKGROUND

• Bond JL, Dopirak RM, Higgins J, Burns J, Snyder SJ. Arthroscopic replacement of massive, irreparable rotator cuff tears using a GraftJacket allograft: technique and preliminary results. Arthroscopy. 2008 Apr;24(4):403-409.e1. doi: 10.1016/j.arthro.2007.07.033.

  PMID: 18375271 BACKGROUND

• Badhe SP, Lawrence TM, Smith FD, Lunn PG. An assessment of porcine dermal xenograft as an augmentation graft in the treatment of extensive rotator cuff tears. J Shoulder Elbow Surg. 2008 Jan-Feb;17(1 Suppl):35S-39S. doi: 10.1016/j.jse.2007.08.005.

  PMID: 18201655 BACKGROUND

• Soler JA, Gidwani S, Curtis MJ. Early complications from the use of porcine dermal collagen implants (Permacol) as bridging constructs in the repair of massive rotator cuff tears. A report of 4 cases. Acta Orthop Belg. 2007 Aug;73(4):432-6.

  PMID: 17939470 BACKGROUND

• Brophy RH, Beauvais RL, Jones EC, Cordasco FA, Marx RG. Measurement of shoulder activity level. Clin Orthop Relat Res. 2005 Oct;439:101-8. doi: 10.1097/01.blo.0000173255.85016.1f.

  PMID: 16205147 BACKGROUND

• Parnes N, Bartoszewski NR, Defranco MJ. Arthroscopic Repair of Full-Thickness Rotator Cuff Tears in Active Patients Younger Than 40 Years: 2- to 5-Year Clinical Outcomes. Orthopedics. 2018 Jan 1;41(1):e52-e57. doi: 10.3928/01477447-20171114-02. Epub 2017 Nov 21.

  PMID: 29156071 BACKGROUND

• Chung SW, Kim JY, Kim MH, Kim SH, Oh JH. Arthroscopic repair of massive rotator cuff tears: outcome and analysis of factors associated with healing failure or poor postoperative function. Am J Sports Med. 2013 Jul;41(7):1674-83. doi: 10.1177/0363546513485719. Epub 2013 Apr 30.

  PMID: 23631883 BACKGROUND

• Greenspoon JA, Petri M, Warth RJ, Millett PJ. Massive rotator cuff tears: pathomechanics, current treatment options, and clinical outcomes. J Shoulder Elbow Surg. 2015 Sep;24(9):1493-505. doi: 10.1016/j.jse.2015.04.005. Epub 2015 Jun 28.

  PMID: 26129871 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Results Point of Contact

• Title: Dr. Gregory Gilot
• Organization: Cleveland Clinic

gilotg@ccf.org

786 566-9176

Study Officials

• Gregory J Gilot, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 11, 2018
• Study Start: July 1, 2018
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: June 19, 2025
• Results First Posted: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)