As tendon allograft use escalates, federal regulations ensure grafts’ safety

KOHALA COAST, Hawaii — Musculoskeletal allograft use, including tendon allografts, has risen dramatically in the past two decades, but those who use these allografts must keep abreast of the regulations governing their use and quality, said a University of California–San Diego orthopedist.

Musculoskeletal graft use increased nearly fourfold from 1990 to 2003, and Americans are using almost 2 million musculoskeletal grafts every year, said William Bugbee, MD, who cited those survey figures from the American Association of Tissue Banks (AATB) during his presentation at Orthopedics Today Hawaii 2009, here.

While tibialis allograft sales are increasing, bone-patellar tendon-bone (BTB) graft use has remained stagnant for the past few years. “What this means is that many tissue banks have BTB allografts stocked in their freezers and are not being used, but many of these same tissue banks cannot keep up with the demand for tibialis tendons,” he said.

Meanwhile, “There are still some questions about the safety of these grafts that we need to ask. For example, do the chemical processes that are a part of the graft preparation process affect the graft’s mechanical or biological [makeup]?” Bugbee said. “Does radiation affect mechanical or biological properties? Are these alterations clinically important? And most importantly, am I willing to trade efficacy for safety?”

The American Academy of Orthopaedic Surgeons (AAOS) addressed allograft safety concerns with the 2007 release of the AAOS Musculoskeletal Allograft Tissue Safety guide, which Bugbee deemed “the official primer on allograft tissue safety.” The AAOS also urged all tissue banks to follow rigorous national standards and guidelines, and recommends orthopedic surgeons use tissue only from banks accredited by the AATB.

Likewise, Bugbee heralded the FDA’s proactive role in recent years to register tissue banks, create donor criteria and implement a Good Tissue Practice (CFR 1271).

In light of these federal efforts, however, “The orthopedic surgeon is still ultimately responsible for the tissue that he implants in his patient, and he or she should know that tissue bank well, not just the sales representative, who often knows as much as or less than the surgeon,” Bugbee said.

Ultimately, “Tendon allografts are extremely safe, and the risk of disease transmission is very small, although the consequences are very great” when something does go wrong, he said. “For example, if a child acquires HIV from a graft, that outcome is not good. And the efficacy of a tendon graft depends on many factors, including donor characteristics, the method of processing, the type of graft and the surgical technique.”

Reference:
Bugbee W. Update on tendon allografts. Presented at Orthopedics Today Hawaii 2009. Jan. 11-14, 2009. Kohala Coast, Hawaii.