Xenograft for anterior cruciate ligament reconstruction was associated with high graft processing infection

Willem Van Der Merwe; Martin Lind; Peter Faunø; Kees Van Egmond; Stefano Zaffagnini; Maurilio Marcacci; Ramon Cugat; Rene Verdonk; Enrique Ibañez; Pedro Guillen; Giulio Maria Marcheggiani Muccioli

doi:10.1186/s40634-020-00292-0

Xenograft for anterior cruciate ligament reconstruction was associated with high graft processing infection

J Exp Orthop. 2020 Oct 7;7(1):79. doi: 10.1186/s40634-020-00292-0.

Affiliations

¹ Sport Science Institute of S. Africa, Cape Town, South Africa.
² Aarhus University Hospital, Aarhus, Denmark.
³ Dept. of Orthopaedic Surgery, Isala Klinieken, Zwolle, Netherlands.
⁴ IRCCS Istituto Ortopedici Rizzoli, University of Bologna, Lab. Biomeccanica - Via di Barbiano, 1/10, 40137, Bologna, Italy.
⁵ IRCCS Humanitas University, Milano / former Istituto Ortopedici Rizzoli, University of Bologna, II Clinica Ortopedica, Bologna, Italy.
⁶ Hospital Quiron, Artoscopia GC, Barcelona, Spain.
⁷ Dept. of Orthopaedic Surgery & Traumatology, Gent Univ. Hospital, Ghent, Belgium.
⁸ Clinica Cemtro, Orthopaedic Surgery & Traumatology, Madrid, Spain.
⁹ IRCCS Istituto Ortopedici Rizzoli, University of Bologna, Lab. Biomeccanica - Via di Barbiano, 1/10, 40137, Bologna, Italy. marcheggianimuccioli@me.com.

Abstract

Purpose: 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.

Conclusions: 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.

Keywords: Allografts; Anterior cruciate ligament; Biomaterial; Reconstruction; Tissue engineering; Xenografts.