Reviewing Proprietary Processed Allograft: BioCleanse^® Process

BioCleanse^®

A recent clinical paper, published Feb 2017, assesses proprietary allograft processing methods including their clinical outcomes and biomechanical properties.

A systematic review was performed using searches of PubMed, EMBASE, Google Scholar, and Cochrane databases. Duplicate studies, studies not providing the allograft processing technique; and those not containing the outcomes of interest were excluded. Outcomes of interest included outcome scores, complication and failure rates; and biomechanical properties of the processed grafts.

The Results?
Twenty-four studies (13 clinical, 11 biomechanical) met inclusion criteria for review. Of all the processes, the BioCleanse^® Process showed the lowest failure rates (5.4%) compared to AlloTrue (5.7%); whilst aseptically processed MTF grafts showed failure rates of 6.7%. The biomechanical studies showed overall maintenance of satisfactory biomechanical properties throughout multiple testing modes.

The Conclusion
Amongst the available literature, except for the Tutoplast^® process, no notable differences were found in the clinical outcomes or biomechanical properties.

Paper Referenced:
"Proprietary Processed" Allografts
Roberson TA, Abildgaard JT, Wyland DJ, Siffri PC, Geary SP, Hawkins RJ, Tokish JM.
Am J Sports Med. 2017 Feb [Epub ahead of print]

The BioCleanse® Tissue Sterilisation Process is RTI Surgical®’s proprietary process for complete sterilisation without the use of irradiation.

Studies have shown that the BioCleanse Process® does not adversely affect the biomechanical properties of allograft tissue. [1,2]

[1.] Schimizzi et al. “Effects of a Novel Sterilization Process on Soft Tissue Mechanical Properties for Anterior Cruciate Ligament Allografts.” American Journal of Sports Medicine. 2007.

[2.] Indelicato et al. “Aseptically processed and chemically sterilized BTB allografts for anterior cruciate ligament reconstruction: a prospective randomized study.” Knee Surgery Sports Traumatology Arthroscopy. 2012."