Usefulness of synthetic graft in knee anterior cruciate ligament reconstruction

PICHON-RIVIERE A,; AUGUSTOVSKI, F; ALCARAZ A; BARDACH, ARIEL; FERRANTE, D; GARCIA MARTÍ, SEBASTIAN; GLUJOVSKY, D; LOPEZ, A; REGUEIRO, A

Documentos de Evaluación de Tecnologías Sanitarias

IECS

Año: 2006 p. 1 - 30

1668-2793

The objective of the report was to assess the available evidence on the usefulness of synthetic grafts (artificial ligaments) in knee anterior cruciate ligament reconstruction.A search was started on the main literature databases (MEDLINE, Cochrane, DARE, LILACS, NHS NICE, EMBASE, Trip Database), on the Internet s general search engines, health technology assessment agencies and health sponsors.Only three randomized clinical trials with very few patients were found. Most evidence comes from case series reports. Gore-tex artificial ligament: Two case series reports and one randomized study versus Kennedy autologous ligament, with a total of 195 analyzed knees were found. The results with the Gore-Tex ligament were, in general, poor. The three studies show high rates of pain and knee joint effusion, low motility scores and high rates of graft loss, around 50% at 5 years. Dacron artificial ligament: Six case series reports were found with a total of 115 patients. The rates of graft failure were high (25% at 21 months and 37% at 50 months), although motility scores were initially good. LARS artificial ligament: One randomized clinical trial versus patellar tendon and one case series report were found.The randomized clinical trial compared ACL reconstruction in patients with chronic instability using autologous patellar tendon in 27 patients and LARS in 26. There were no differences in the rate of failure between the groups (two knees in the LARS group an one in the patellar group) at 24 months. No differences were observed in the increase in activity throughout follow-up. Results using the Knee and Osteoarthritis Outcome Score (KOOS) were higher in the LARS group during the first year of follow-up, mainly in the fields related to sports and recreation (p= 0.04) and quality of life (p= 0.02), but there were no differences as regards the patellar group in any of the fields at 24 months. Ligament laxity was higher in the LARS group at 6 months (p= 0.01), but similar to that of the patellar group at 24 months. The case series report which included 47 patients with a median follow-up of 19 months shows good scores in the osteoarthritis questionnaire. The motility score was significantly higher after surgery, but lower than that before injury. 8.5% of the patients required a new surgical intervention.Leeds Keio artificial ligament: One randomized clinical trial versus patellar tendon and four case series reports were found. The randomized trial included 60 patients with chronic unilateral ACL rupture, with autologous patellar tendon reconstruction (26 patients) or Leeds-Keio artificial ligament (29 patients). The mean follow-up was 28 months. Results favored the autologous tendon, with significantly lower knee instability (4% vs. 48%) and a higher number of patients with a degree of motion considered excellent (27% vs. 10%).The four case series reports with a total of 207 patients reported total rates of failure of around 15-17% at 5 years, rates of ligament rupture of 28% and ligament laxity of 56% at 13 years. Leeds Keio II artificial ligament: Only one case series report published this year was found which reported the follow-up of 13 patients for at least 12 months who did not develop significant complications.In Argentina, only LARS (Ligament Advanced Reinforcement System) synthetic ligament is commercially available. Its cost is $9,500 (Argentine pesos 2006) including titanium interference screws and one staple. This does not include surgical expenses or medical fees.