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

作者：Indelicato Peter A^*; Ciccotti Michael G; Boyd Joel; Higgins Laurence D; Shaffer Benjamin S; Vangsness C Thomas Jr

来源：Knee Surgery, Sports Traumatology, Arthroscopy, 2013, 21(9): 2107-2112.

DOI：10.1007/s00167-012-2309-7

• Anterior cruciate
• Allograft
• Sterilized
• Outcomes
• IKDC

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. %26lt;br%26gt;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). %26lt;br%26gt;After randomization, 24 patients received aseptic BTB allografts and 43 patients received BioCleanse-sterilized allografts. Significant improvement in IKDC scores (P %26lt; 0.0001) as well as KT-1000 results (P %26lt; 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 %26lt; 0.0001) with no difference between groups at any time point. Active extension ROM did not differ significantly between the two groups. %26lt;br%26gt;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. %26lt;br%26gt;II.

• 出版日期2013-9