Biabsorbable Versus Metalic Screws for Anterior Cruciate Ligament Reconstruction

PICHON RIVIERE, A.; AUGUSTOVSKI, F.; GARCIA MARTI, S.; GLUJOVSKY, D.; ALCARAZ, A.; LOPEZ, A.; BARDACH, A.; CIAPPONI, A

Documento de Evaluación de tecnologías Sanitarias

IECS

Año: 2013 p. 1 - 30

1668-2793

Anterior cruciate ligament reconstruction (ACLR) is one of the most common procedures carried out in orthopedic surgery, mainly in young people and athletes. Although the result of these interventions is satisfactory or excellent in 85%-95% of the patients, there are still doubts regarding the techniques used for graft fixation.Conventional surgery uses metallic screws which give a very strong initial fixation, but they could cause suture and graft laceration, a distorted magnetic resonance imaging view during postsurgical evaluation or else, the need of removal during revision surgery. Bioabsorbable screws on the other, because they degrade with time, could lessen these effects, therefore they are proposed for graft fixation in ACLR.TechnologyBioabsorbable screws are designed to degrade with time and are made of different biological polymers.PurposeTo assess the available evidence on the efficacy, safety and coverage policy related aspects on the use of bioabsorbable screws for anterior cruciate ligament reconstruction.MethodsA bibliographic search was carried out on the main databases: DARE, NHS EED, on Internet general search engines, in health technology evaluation agencies and health sponsors. Priority was given to the inclusion of systematic reviews; controlled, randomized clinical trials (RCTs); health technology assessments and economic evaluations; clinical practice guidelines and coverage policies of other health systems.ResultsThree systematic reviews, two of them with meta-analysis, three randomized clinical trials (RCTs) and one clinical practice guideline were included. No health technology assessments or coverage policies were found.In 2011, a systematic review was published with meta-analysis comparing the results of bioabsorbable versus metallic screw use for ACLR. It included eight studies with a total of 745 patients and mean follow-up of 12 months. No significant differences were found regarding knee function, activity or stability based on the results measured according to different scales (IKDC, Lysholm, Tegner activity). Also, there were no significant differences as regards the laxity arthrometer test and adverse effects.Another systematic review with meta-analysis published in 2010 compared the results of bioabsorbable versus metallic screw use for ACLR. It included 10 RCTs with a total of 790 patients. There were two studies included in this meta-analysis, but not in the one from 2011, one which showed preliminary results and another which included as only significant clinical result the evaluation of tunnel widening. In this systematic review, no significant differences were found as regards joint stability or function after a 24-month follow-up. Joint effusion was more frequent after bioabsorbable screw use, with an incidence of 6,54% versus 2,41% (RR 2,57; 95%CI 1,03 to 6,43; p=0,04).Three studies published after the date of the last meta-analysis search showed similar findings. No significant differences were found for joint stability, activity and function, laxity or side effects.Regarding tunnel widening performed to the thighbone during surgery in one of the RCTs, the group treated with bioabsorbable screws showed a statistically significant increase with a mean of 11.4 mm versus 8.0 mm (p <0.005).A clinical practice guideline published in 2009, recommended the use of bioabsorbable or metallic interference screws, indistinctly, since there are no differences in the clinical results obtained with both.The costs of biobasorbable screws in Argentina in August 2012 was three times that of the metallic screws.ConclusionsThe quality of the evidence found is good.No significant differences were found in the main clinical results such as knee stability, function and laxity. One of the meta-analysis found greater joint effusion in the group using bioabsorbable screws, whereas the other meta-analysis did not. The advantages attributed to the bioabsorbable screws (they do not interfere in the magnetic resonance imaging study and do not need to be removed) compared to the metallic screws do not justify their use in every day practice. Their cost is high, therefore inclusion in the health systems will depend on system?s economic possibilities.