Aseptically processed and chemically sterilized BTB allografts for anterior cruciate ligament reconstruction: a prospective randomized study
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.
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).
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.
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
- Aseptically processed and chemically sterilized BTB allografts for anterior cruciate ligament reconstruction: a prospective randomized study
- Open Access
- Available under Open Access This content is freely available online to anyone, anywhere at any time.
Knee Surgery, Sports Traumatology, Arthroscopy
Volume 21, Issue 9 , pp 2107-2112
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- Springer Berlin Heidelberg
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- Anterior cruciate
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- Author Affiliations
- 1. Department of Orthopaedics and Rehabilitation, University of Florida, 3450 Hull Road, Gainesville, FL, 32607, USA
- 2. Rothman Institute, Department of Orthopaedic Surgery, Thomas Jefferson University, Philadelphia, PA, USA
- 3. TRIA Orthopaedic Center, Minneapolis, MN, USA
- 4. Department of Orthopedic Surgery, Brigham and Women’s Hospital-Ortho, Boston, MA, USA
- 5. Washington Orthopaedic and Sports Surgery Center, Clinical Orthopedics, George Washington University, Washington, DC, USA
- 6. Department of Orthopaedic Surgery, University of Southern California, Los Angeles, CA, USA