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

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.