LifeNet: Extracellular Matrix Graft in Rotator Cuff Repair

Gregory Gilot

Status and phase: Terminated; Phase 4

Conditions: Rotator Cuff Tear

Treatments: Procedure: Control; Procedure: ArthroFLEX ECM scaffold graft; Biological: Alternative Treatment Group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03551509

FLA 18-008

Details and patient eligibility

About

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.

Full description

This is a prospective, randomized, controlled, multi-center clinical trial to evaluate the effectiveness of an ECM scaffold graft to augment repair of a large/massive rotator cuff tear. The study will involve 70 patients. 35 patients will be randomly assigned to each arm of the study.

Despite advances in surgical technology, repairs of large (3-5 cm) and massive (>5 cm) rotator cuff tears (RCT) fail between 20%-90% of the time [1]. Due to their size and increased structural involvement, large or massive RCT present a substantial challenge to orthopaedic surgeons. [16] The repairs tend to fail at the suture-tendon junction, which is due to several factors, including tension at the repair and quality of the tendon [1-2,5]. Full thickness tears are uncommon in younger patients, especially those less than forty years old and are usually traumatic in etiology. Younger patients also typically fair better following arthroscopic rotator cuff repair with fewer failures and more successful return to pre-injury level of function [16]. One strategy to augment repair of large to massive rotator cuff tears has been the development of biological scaffold materials, which are composed of extracellular matrix (ECM). The ECM composing the scaffolds are made from a number of tissues, including, but not limited to, small intestinal submucosa (SIS), dermis, and pericardium [3]. Studies to date include both prospective and retrospective in animal and human models, and include Restore, a porcine-derived SIS by DePuy Orthopaedics, GraftJacket, a human-derived, non-cross-linked dermis graft by Wright Medical Technology, and Zimmer Collagen Repair, a cross-linked porcine derived dermal graft made by Zimmer. Restore studies have shown no benefit and some even an increase in repair failure with recommendations not to use to augment repair. GraftJacket studies have shown a reduction in graft failure; however, several of the Restore and GraftJacket studies are limited by a lack of a control cohort. The Zimmer graft studies have conflicting results with both an improvement and no improvement in failure rates of repair. The prior studies listed are all in vivo; however, the majority are not randomized trials and thus do not have a control with which to compare data. In addition, some trials include open repairs. A lack of prospective, randomized, controlled, in vivo trials exist that evaluate the ability of the ECM scaffold graft augmentation in large to massive arthroscopic rotator cuff repairs to decrease the failure rate.

The purpose of this study is to evaluate the efficacy of using the Arthroflex (A-FLEX) graft to augment large to massive arthroscopic rotator cuff repairs in vivo and decrease repair failures in a prospective, randomized, controlled trial. By undergoing serial US examinations at follow-ups, we also intend to evaluate when during the postoperative period the failure of the repair occurs.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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9 participants in 3 patient groups

Control Treatment Group

Active Comparator group

Description:

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.

Treatment:

Procedure: Control

Treatment Group

Active Comparator group

Description:

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.

Treatment:

Procedure: ArthroFLEX ECM scaffold graft

Alternative Treatment Group

Other group

Description:

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.

Treatment:

Biological: Alternative Treatment Group