2021 ISAKOS Biennial Congress Paper
Xenograft For Anterior Cruciate Ligament Reconstruction Was Associated With High Graft Processing Infection.
Willem M. van der Merwe, MBChB, FCS(SA)Ortho, Cape Town, WC SOUTH AFRICA
Martin Lind, MD, PhD, Prof., Aarhus N DENMARK
Peter Faunoe, MD, Risskov DENMARK
Kees van Egmond, MD, Nieuwleusen, Overijssel NETHERLANDS
Stefano Zaffagnini, MD, Prof., Bologna ITALY
Maurilio Marcacci, MD, Milano, Milano ITALY
Ramon Cugat Bertomeu, MD, PhD, Barcelona, Barcelona SPAIN
Rene E. Verdonk, Prof em , MD, PhD, Gent BELGIUM
Ernique Ibanez, MD, PhD, Madrid SPAIN
Giulio Maria Marcheggiani Muccioli, MD, PhD, Associate Professor, Bologna ITALY
multicenter trial (Europe and South Africa), Bologna, ITALY
The FDA has not cleared the following pharmaceuticals and/or medical device for the use described in this presentation. The following pharmaceuticals and/or medical device are being discussed for an off-label use: Aperion Biologics, Inc., Z-Lig
Summary
High infection rate (20.6%) was reported after ACL reconstruction (ACLR) with xenograft. Improvements in future studies using xenografts are needed, otherwise xenograft should not be used in ACLR.
Abstract
Introduction
The purpose of this study was to evaluate clinical ad radiological outcomes of anterior cruciate ligament (ACL) reconstruction with an immunochemically modified porcine patellar tendon xenograft controlled against human Achilles tendon allograft at 24-month minimum follow-up.
Methods
66 patients undergoing arthroscopic ACL reconstruction were randomized into 2 groups: 34 allografts and 32 xenografts treated to attenuate the host immune response. Follow-up was 24-month minimum. Anterior knee stability was measured as KT-1000 side-to-side laxity difference (respect to the contralateral healthy knee). Functional performance was assessed by one-legged hop test. Objective manual pivot-shift test and subjective (IKDC, Tegner and SF-36) outcomes were collected. MRI and standard X-Ray were performed.
Results
61 subjects (32 allograft, 29 xenograft) were evaluated at 12 and 24 months. Six of the subjects in xenograft group (20.6%) got an infection attributed to a water-based pathogen graft contamination in processing.
Intention-to-treat analysis (using the last observation carried forward imputation method) revealed higher KT-1000 laxity in xenograft group at 24-month follow-up (P = .042). Also pivot-shift was higher in xenograft group at 12-month (P = .015) and 24-month follow-up (P = .038).
Per-protocol analysis (missing/contaminated subjects excluded) did not revealed clinical differences between groups. Tibial tunnel widening in the allograft group was low, whereas xenograft tunnel widening was within the expected range of 20-35% as reported in the literature.
No immunological reactivity was associated to xenograft group.
Discussion And Conclusion
High infection rate (20.6%) was reported in xenograft group. Both groups of patients achieved comparable clinical outcomes if missing/contaminated subjects are excluded. Improved harvesting/processing treatments in future studies using xenografts for ACL reconstruction are needed to reduce infection rate, otherwise xenograft should not be used in ACL reconstruction.
Level of evidence: multicenter and double-blinded Randomized Controlled Clinical Trial, Level I.