Reviewing Proprietary Processed Allograft: BioCleanse® Process

BioCleanse Allograft Processing Review

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

You can learn full details of the BioCleanse® Tissue Sterilisation Process by watching the following video.

 

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."

 

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