To compare the clinical outcomes of bone-patellar tendon-bone (BTB) allografts sterilised through a novel sterilisation system with aseptically processed BTB allografts for Anterior Cruciate Ligament (ACL) reconstruction. The following hypotheses were also tested: (1) the cumulative score of the IKDC is not significantly different in the sterilised treatment group than in the aseptic control group, (2) the proportion of normal laxity in patients, as measured by the KT 2000 arthrometer, is not significantly different in the sterilised group than in the aseptic control group. A total of 76 patients undergoing ACL reconstruction were randomised into one of two intervention groups, BioCleanse¯-sterilised or Aseptic BTB allografts, at 6 independent investigation sites. Post-op examiners and patients were blinded to graft type. Patients were evaluated at 6 months (44 of the 76), 12 months (20 of the 76), and 24 months (27 of the 76) with KT-2000, IKDC scores, and Flexion and Extension Range of Motion (ROM) analysis. Inclusion criteria included an acute, isolated, unilateral ACL tear and exclusion criteria included prior ACL injury, multiligament reconstruction, and signs of degenerative joint disease.Objective
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