{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,24]],"date-time":"2026-02-24T09:35:38Z","timestamp":1771925738242,"version":"3.50.1"},"reference-count":43,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2012,12,1]],"date-time":"2012-12-01T00:00:00Z","timestamp":1354320000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Knee surg. sports traumatol. arthrosc."],"published-print":{"date-parts":[[2013,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>To compare the clinical outcomes of bone\u2010patellar tendon\u2010bone (BTB) allografts processed via a novel sterilization system with the traditional aseptically processed BTB allografts for anterior cruciate ligament (ACL) reconstruction.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A total of 67 patients undergoing ACL reconstruction at 6\u00a0independent investigation sites were randomized into one of two intervention groups, BioCleanse\u2010sterilized or aseptic BTB allografts. Inclusion criteria included an acute, isolated, unilateral ACL tear, and exclusion criteria included prior ACL injury, multi\u2010ligament reconstruction, and signs of degenerative joint disease. Post\u2010op examiners and patients were blinded to graft type. Patients were evaluated at 6, 12, and 24\u00a0months. Clinical outcomes were compared using the IKDC, a KT\u20101000\u00a0knee arthrometer, level of effusion, and ranges of motion (ROM).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>After randomization, 24 patients received aseptic BTB allografts and 43 patients received BioCleanse\u2010sterilized allografts. Significant improvement in IKDC scores (<jats:italic>P<\/jats:italic> &lt; 0.0001) as well as KT\u20101000 results (<jats:italic>P<\/jats:italic> &lt; 0.0001) was noted over the 24\u2010month period for both groups. IKDC or KT\u20101000 results were not significantly different between groups at any time point. Active flexion ROM significantly improved from pre\u2010op to 24\u2010month follow\u2010up (<jats:italic>P<\/jats:italic> &lt; 0.0001) with no difference between groups at any time point. Active extension ROM did not differ significantly between the two groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>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\u2010to\u2010recipient disease.<\/jats:p><\/jats:sec><jats:sec><jats:title>Level of evidence<\/jats:title><jats:p>II.<\/jats:p><\/jats:sec>","DOI":"10.1007\/s00167-012-2309-7","type":"journal-article","created":{"date-parts":[[2012,11,29]],"date-time":"2012-11-29T23:44:11Z","timestamp":1354232651000},"page":"2107-2112","source":"Crossref","is-referenced-by-count":18,"title":["Aseptically processed and chemically sterilized BTB allografts for anterior cruciate ligament reconstruction: a prospective randomized study"],"prefix":"10.1002","volume":"21","author":[{"given":"Peter A.","family":"Indelicato","sequence":"first","affiliation":[{"name":"<!--<label>1<\/label>--> Department of Orthopaedics and Rehabilitation University of Florida 3450 Hull Road 32607 Gainesville FL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael G.","family":"Ciccotti","sequence":"additional","affiliation":[{"name":"<!--<label>2<\/label>--> Rothman Institute, Department of Orthopaedic Surgery Thomas Jefferson University Philadelphia PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joel","family":"Boyd","sequence":"additional","affiliation":[{"name":"<!--<label>3<\/label>--> TRIA Orthopaedic Center Minneapolis MN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laurence D.","family":"Higgins","sequence":"additional","affiliation":[{"name":"<!--<label>4<\/label>--> Department of Orthopedic Surgery Brigham and Women\u2019s Hospital\u2010Ortho Boston MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benjamin S.","family":"Shaffer","sequence":"additional","affiliation":[{"name":"<!--<label>5<\/label>--> Washington Orthopaedic and Sports Surgery Center, Clinical Orthopedics George Washington University Washington DC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"suffix":"Jr.","given":"C. 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