A PROSPECTIVE, RANDOMISED CLINICAL COMPARISON BETWEEN ASEPTICALLY PROCESSED AND CHEMICALLY STERILISED BTB ALLOGRAFTS FOR ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: RESULTS FROM 2 YEAR FOLLOW-UP

Peter A. Indelicato; Michael G. Ciccotti; Joel L. Boyd; Laurence D. Higgins; Benjamin S. Shaffer; C. Thomas Vangsness

doi:10.1302/1358-992X.94BSUPP_XXIX.BASK2011-012

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A PROSPECTIVE, RANDOMISED CLINICAL COMPARISON BETWEEN ASEPTICALLY PROCESSED AND CHEMICALLY STERILISED BTB ALLOGRAFTS FOR ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: RESULTS FROM 2 YEAR FOLLOW-UP

British Association for Surgery of the Knee (BASK)

Peter A. Indelicato
Michael G. Ciccotti
Joel L. Boyd
Laurence D. Higgins
Benjamin S. Shaffer
C. Thomas Vangsness

A PROSPECTIVE, RANDOMISED CLINICAL COMPARISON BETWEEN ASEPTICALLY PROCESSED AND CHEMICALLY STERILISED BTB ALLOGRAFTS FOR ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: RESULTS FROM 2 YEAR FOLLOW-UP

Indelicato PA, Ciccotti MG, Boyd JL, Higgins LD, Shaffer BS, Vangsness CT. A PROSPECTIVE, RANDOMISED CLINICAL COMPARISON BETWEEN ASEPTICALLY PROCESSED AND CHEMICALLY STERILISED BTB ALLOGRAFTS FOR ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: RESULTS FROM 2 YEAR FOLLOW-UP. Orthop Procs. 2012;94-B(SUPP_XXIX):12-12. doi:10.1302/1358-992X.94BSUPP_XXIX.BASK2011-012

Indelicato, Peter A., et al. “A PROSPECTIVE, RANDOMISED CLINICAL COMPARISON BETWEEN ASEPTICALLY PROCESSED AND CHEMICALLY STERILISED BTB ALLOGRAFTS FOR ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: RESULTS FROM 2 YEAR FOLLOW-UP.” Orthopaedic Proceedings, vol. 94-B, no. SUPP_XXIX, 2012, pp. 12-12., https://doi.org/10.1302/1358-992X.94BSUPP_XXIX.BASK2011-012

Indelicato, P. A., Ciccotti, M. G., Boyd, J. L., Higgins, L. D., Shaffer, B. S., & Vangsness, C. T. (2012). A PROSPECTIVE, RANDOMISED CLINICAL COMPARISON BETWEEN ASEPTICALLY PROCESSED AND CHEMICALLY STERILISED BTB ALLOGRAFTS FOR ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: RESULTS FROM 2 YEAR FOLLOW-UP. Orthopaedic Proceedings, 94-B(SUPP_XXIX), 12-12. https://doi.org/10.1302/1358-992X.94BSUPP_XXIX.BASK2011-012

Indelicato, P. A., Ciccotti, M. G., Boyd, J. L., Higgins, L. D., Shaffer, B. S. and Vangsness, C. T. (2012) “A PROSPECTIVE, RANDOMISED CLINICAL COMPARISON BETWEEN ASEPTICALLY PROCESSED AND CHEMICALLY STERILISED BTB ALLOGRAFTS FOR ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: RESULTS FROM 2 YEAR FOLLOW-UP.” Orthopaedic Proceedings, 94-B(SUPP_XXIX), pp. 12-12. Available at: https://doi.org/10.1302/1358-992X.94BSUPP_XXIX.BASK2011-012

Indelicato, Peter A., Michael G. Ciccotti, Joel L. Boyd, Laurence D. Higgins, Benjamin S. Shaffer, and C. Thomas Vangsness. “A PROSPECTIVE, RANDOMISED CLINICAL COMPARISON BETWEEN ASEPTICALLY PROCESSED AND CHEMICALLY STERILISED BTB ALLOGRAFTS FOR ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: RESULTS FROM 2 YEAR FOLLOW-UP.” Orthopaedic Proceedings 94-B, no. SUPP_XXIX (2012): 12-12. https://doi.org/10.1302/1358-992X.94BSUPP_XXIX.BASK2011-012

Indelicato PA, Ciccotti MG, Boyd JL, Higgins LD, Shaffer BS, Vangsness CT. A PROSPECTIVE, RANDOMISED CLINICAL COMPARISON BETWEEN ASEPTICALLY PROCESSED AND CHEMICALLY STERILISED BTB ALLOGRAFTS FOR ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: RESULTS FROM 2 YEAR FOLLOW-UP. Orthop Procs. 2012 Jul 1;94-B(SUPP_XXIX):12-12. https://doi.org/10.1302/1358-992X.94BSUPP_XXIX.BASK2011-012

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Abstract

Objective

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.

Methods

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.

Results

Significant improvement (p<.0001) in IKDC scores was noted in both groups over time. Similarly, a significant improvement (p<.0001) was observed in KT-2000 results over the 24-month period for both groups. There was no difference between graft types at any time point regarding IKDC or KT-2000 scores. There was also no significant difference in active extension ROM between the two groups. Active flexion ROM significantly improved from pre-op to 24 month follow-up (p<.0001) with no difference between groups at any time point.

Conclusions

Results indicate that the sterilisation process, BioCleanse^¯, does not appear to have an effect on the biomechanics or healing ability of the BTB allograft. BioCleanse^¯ may provide surgeons with allografts similar to aseptically processed allograft tissue with the benefit of eliminating donor-to-recipient disease transmission.