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Xenograft For Anterior Cruciate Ligament Reconstruction Was Associated With High Graft Processing Infection.


Giulio Maria Marcheggiani Muccioli, MD, PhD, Associate Professor
ITALY

Xenograft For Anterior Cruciate Ligament Reconstruction Was Associated With High Graft Processing Infection.

Willem M. van der Merwe, MBChB, FCS(SA)Ortho, SOUTH AFRICA Martin Lind, MD, PhD, Prof., DENMARK Peter Faunoe, MD, DENMARK Kees van Egmond, MD, NETHERLANDS Stefano Zaffagnini, MD, Prof., ITALY Maurilio Marcacci, MD, ITALY Ramon Cugat Bertomeu, MD, PhD, SPAIN Rene E. Verdonk, Prof Em, MD, PhD, BELGIUM Ernique Ibanez, MD, PhD, SPAIN Giulio Maria Marcheggiani Muccioli, MD, PhD, Associate Professor, ITALY

multicenter trial (Europe and South Africa), Bologna, ITALY

2021 Congress   Abstract Presentation   6 minutes   Not yet rated

 

Anatomic Location

Knee

Anatomic Structure

Ligaments

Diagnosis / Condition

Sprain

Treatment / Technique

Transplantation

Ligaments

ACL

Diagnosis Method

X-ray MRI

Sports Medicine

Outcome Studies

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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.

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.

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