MARCH 22–SAN FRANCISCO, Calif.–Clinical findings presented at the recent annual meeting of the American Association of Orthopedic Surgeons showed that patients who received human tissue allograft implants that were treated with a new pathogen inactivation method were not likely to acquire a bacterial and viral infection.
According to Dr. Warren King of the Palo Alto Medical Foundation, the study’s principle investigator, the performance evaluation showed that the Clearant Inc. process treated implants had an “excellent clinical outcome as measured by a standard set of orthopedic tests and rehabilitation benchmarks.”
In this prospective study, 50 patients received ACL reconstruction surgery (a procedure to repair a tear in the ligament that connects the thighbone to the shinbone) using Achilles tendons that had been bacterially sterilized and virally inactivated using either the Clearant Process or traditionally aseptically processed tissue implants.
“At six months of follow-up, the results in terms of basic performance, such as range and ease of motion after surgery, were comparable to those achieved with traditionally processed implants,” he says. “This shows that the pathogen inactivation procedure is not damaging the structural integrity of the tissue. We would expect patients to continue to improve over the full course of the rehabilitation period.”
More than 800,000 tissue allografts are implanted each year with few reports of serious complications. Since 1990, the use of these products has more than doubled. However, over the past two decades a number of serious and even deadly diseases have been shown to be transmissible through tissue allografts, including HIV, hepatitis C, and West Nile Virus. The Clearant Process is the only current pathogen inactivation technology that substantially reduces all types of pathogens, including bacteria and viruses which may be present in human tissue, without compromising the quality of the tissue.
The Clearant Process is designed to be used for allograft tissue in the final container, thereby allowing the final product to be “terminally sterilized” for use in the operating room. Rigorous validation studies have demonstrated that the even the most resistant strains of bacteria are inactivated by the Clearant Process. In addition, Clearant has demonstrated inactivation of both enveloped and non-enveloped viruses.
Furthermore, biomechanical testing in the laboratory and clinical experience have demonstrated that the safety and efficacy of Clearant Process treated allografts is comparable to, or better than, traditionally processed allografts.
“This study shows that we can achieve thorough pathogen inactivation together with top-quality clinical performance,” says Alain Delongchamp, Clearant’s chief operating office. “By combining the Clearant Process with traditional infection control methodologies, such as donor screening and aseptic processing and cleansing, we can practically eliminate the risk of infection associated with human tissue allografts.”