RTI Biologics, a provider of orthopedic and biologic implants, has reported positive results from a randomised, prospective clinical study of its BioCleanse-processed bone-patellar tendon-bone (BTB) allografts, designed for use in anterior cruciate ligament (ACL) reconstruction surgery.
Designed as a safe alternative to autografts (the use of a patient's own tissue), BTB allografts are processed using the company's patented BioCleanse Tissue Sterilisation Process to remove bacteria, fungi, spores and viruses.
The one disadvantage compared with autografts or metal and synthetic implants, is that disease can be transmitted as a result of an aseptically-processed allograft, according to the company.
The low-temperature process uses a combination of mechanical and chemical processes and sterilises tissue to SAL 10-6 without compromising the biocompatibility or structural integrity.
RTI Biologics executive vice president and chief commercial officer Roger Rose said; "BioCleanse sterilises tissue without the potentially harmful side effects of other methods."
RTI Biologics president and CEO Brian Hutchison said; "Surgeons and patients can rest assured knowing that RTI provides allografts that will maintain their biomechanical integrity the same as aseptically-processed implants, while addressing the risk of donor-to-recipient infection."
The study, which evaluated 67 patients undergoing ACL reconstruction at six independent investigation sites for up to six, 12 and 24 months, was designed to compare the clinical outcomes of BTB allografts processed using BioCleanse Process with a control group consisting of aseptically-processed allografts from the three US tissue banks.
Patients were then randomised into two groups with 24 patients receiving aseptic BTB allografts and 43 patients receiving BioCleanse sterilised allografts.
The results indicate that the sterilisation process did not demonstrate a statistical difference in clinical outcomes for the BTB allograft at two years.
The study, however, demonstrated that the BioCleanse process may provide surgeons with allografts clinically similar to aseptically-processed allograft tissue, with the benefit of addressing donor-to-recipient disease.