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

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DOI

  • Willem Van Der Merwe, Sport Science Institute of S. Africa
  • ,
  • Martin Lind
  • Peter Faunø
  • Kees Van Egmond, Isala Clinics
  • ,
  • Stefano Zaffagnini, University of Bologna
  • ,
  • Maurilio Marcacci, University of Bologna
  • ,
  • Ramon Cugat, Hospital Quiron, Artoscopia GC
  • ,
  • Rene Verdonk, Ghent University
  • ,
  • Enrique Ibañez, Clínica Cemtro
  • ,
  • Pedro Guillen, Clínica Cemtro
  • ,
  • Giulio Maria Marcheggiani Muccioli, University of Bologna

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.

OriginalsprogEngelsk
Artikelnummer79
TidsskriftJournal of experimental orthopaedics
Vol/bind7
ISSN2197-1153
DOI
StatusUdgivet - okt. 2020

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