Progress in Rotator Cuff Repair Extends to the Lab

As Gregory Gilot, MD, further refines his scaffold-based augmentation technique in Florida (see related post), his colleagues at Cleveland Clinic’s main campus have been developing novel fiber-reinforced extracellular matrix (ECM) scaffolds for musculoskeletal soft tissue repair.

A Cleveland Clinic team led by Kathleen Derwin, PhD, saw its patent-pending design for a reinforced allograft fascia lata patch receive 510(k) clearance from the FDA in November 2012. The patch was approved for use in reinforcing soft tissues repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of rotator cuff, patellar, Achilles, biceps and other tendons.

Use of fascia lata gives the patch structural and biochemical properties similar to those of tendons and distinct from other ECM-derived scaffolds, explains Dr. Derwin, of the Departments of Orthopaedic Surgery and Biomedical Engineering. “However, native fascia lata has poor suture-retention properties, which limits its usefulness as a tendon-like scaffold for rotator cuff repair augmentation,” she says. “We reinforced fascia ECM with PLLA polymer braids to engineer the suture-retention properties of fascia to meet the needs of musculoskeletal applications.”

The Derwin lab has published studies showing that:

• The patch maintains its suture-retention properties before and after implantation in a rat subcutaneous model.

• Augmentation with the patch decreased cyclic gap formation compared with nonaugmented repairs in a human cadaver model.

“These studies demonstrate the potential for a reinforced fascia patch to provide mechanical augmentation, minimize tendon retraction and possibly reduce the incidence of rotator cuff repair failure,” notes Dr. Derwin. Her lab is now seeking funding for a first-in-human study of the patch.

Schematic illustration of the reinforced allograft fascia lata patch.