Aseptically processed and chemically sterilized BTB allografts for anterior cruciate ligament reconstruction: a prospective randomized study.

Authors

Peter A Indelicato, Department of Orthopaedics and Rehabilitation, University of Florida
Michael G Ciccotti, Rothman Institute, Department of Orthopaedic Surgery, Thomas Jefferson UniversityFollow
Joel Boyd, TRIA Orthopaedic Center, Minneapolis, MN, United States
Laurence D Higgins, Department of Orthopedic Surgery, Brigham and Women's Hospital-Ortho
Benjamin S Shaffer, Washington Orthopaedic and Sports Surgery Center, Clinical Orthopedics, George Washington University
C Thomas Vangsness, Department of Orthopaedic Surgery, University of Southern California

Document Type

Article

Publication Date

9-1-2013

Comments

This article has been peer reviewed. It was published in: Knee Surgery, Sports Traumatology, Arthroscopy.

Volume 21, Issue 9, September 2013, Pages 2107-2112.

The published version is available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3751503/. DOI: 10.1007/s00167-012-2309-7

Copyright © 2012 The Author(s).

Abstract

PURPOSE: To compare the clinical outcomes of bone-patellar tendon-bone (BTB) allografts processed via a novel sterilization system with the traditional aseptically processed BTB allografts for anterior cruciate ligament (ACL) reconstruction.

METHODS: A total of 67 patients undergoing ACL reconstruction at 6 independent investigation sites were randomized into one of two intervention groups, BioCleanse-sterilized or aseptic BTB allografts. Inclusion criteria included an acute, isolated, unilateral ACL tear, and exclusion criteria included prior ACL injury, multi-ligament reconstruction, and signs of degenerative joint disease. Post-op examiners and patients were blinded to graft type. Patients were evaluated at 6, 12, and 24 months. Clinical outcomes were compared using the IKDC, a KT-1000 knee arthrometer, level of effusion, and ranges of motion (ROM).

RESULTS: After randomization, 24 patients received aseptic BTB allografts and 43 patients received BioCleanse-sterilized allografts. Significant improvement in IKDC scores (P < 0.0001) as well as KT-1000 results (P < 0.0001) was noted over the 24-month period for both groups. IKDC or KT-1000 results were not significantly different between groups at any time point. Active flexion ROM significantly improved from pre-op to 24-month follow-up (P < 0.0001) with no difference between groups at any time point. Active extension ROM did not differ significantly between the two groups.

CONCLUSIONS: These results indicate that the sterilization process, BioCleanse, did not demonstrate a statistical difference in clinical outcomes for the BTB allograft at 2 years. The BioCleanse process may provide surgeons with allografts clinically similar to aseptically processed allograft tissue with the benefit of addressing donor-to-recipient disease.

LEVEL OF EVIDENCE: II.

Recommended Citation

Indelicato, Peter A; Ciccotti, Michael G; Boyd, Joel; Higgins, Laurence D; Shaffer, Benjamin S; and Vangsness, C Thomas, "Aseptically processed and chemically sterilized BTB allografts for anterior cruciate ligament reconstruction: a prospective randomized study." (2013). Department of Orthopaedic Surgery Faculty Papers. Paper 57.
https://jdc.jefferson.edu/orthofp/57

PubMed ID

23203337