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Commercial Extracellular Matrix Scaffolds for Rotator Cuff Tendon Repair

Biomechanical, Biochemical, and Cellular Properties

¹ Department of Biomedical Engineering, ND-20, Lerner Research Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195. E-mail address for K.A. Derwin: derwink{at}ccf.org
² Department of Orthopaedic Surgery, A-41, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195

Investigation performed at the Lerner Research Institute and Orthopaedic Research Center, The Cleveland Clinic Foundation, Cleveland, Ohio

The authors did not receive grants or outside funding in support of their research for or preparation of this manuscript. They did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

Methods: Samples were tested from different manufacturing lots of four materials: GraftJacket (ten lots), TissueMend (six), Restore (ten), and CuffPatch (six). The Kruskal-Wallis test was used to compare thickness, stiffness, and modulus as well as hydroxyproline, chondroitin/dermatan sulfate glycosaminoglycan, hyaluronan, and DNA contents among these matrices. The moduli of the extracellular matrices were also compared with those of normal canine infraspinatus tendon.

Results: All four extracellular matrices required 10% to 30% stretch before they began to carry substantial load. Their maximum moduli were realized in their linear region at 30% to 80% strain. The elastic moduli of all four commercial matrices were an order of magnitude lower than that of canine infraspinatus tendon. TissueMend had significantly higher DNA content than the other three matrices (p < 0.0001), although both Restore and GraftJacket also had measurable amounts of DNA.

Conclusions: Our data demonstrate chemical and mechanical differences among the four commercial extracellular matrices that we evaluated. Probably, the source (dermis or small intestine submucosa), species (human, porcine, or bovine), age of the donor (fetal or adult), and processing of these matrices all contribute to the unique biophysical properties of the delivered product. The biochemical composition of commercial extracellular matrices is similar to that of tendon. However, the elastic moduli of these materials are an order of magnitude lower than that of tendon, suggesting a limited mechanical role in augmentation of tendon repair.

Clinical Relevance: These data will help inform and guide the clinical community with regard to the appropriate use of commercially available extracellular matrix products for augmentation of rotator cuff tendon repair. Knowledge of the biophysical properties of these materials is fundamental to making an educated decision about whether a given matrix might provide mechanical augmentation and/or enhance the biology of tendon-to-bone healing.

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