67 patients with an acute (<4 months), isolated, unilateral ACL rupture were randomized to evaluate the efficacy of the BioCleanse sterilization technique against traditional aseptic processing for bone-patellar tendon-bone (BTB) allografts. Patients were assessed over 24 months using the International Knee Documentation Committee (IKDC) form outcome, range of motion (ROM) effusion and a KT-1000 knee arthrometer test. This study demonstrates that the use of the BioCleanse technique exhibits similar clinical outcomes to aseptic processing for BTB allografts and that no complications were associated with BioCleanse use.