ACL Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation

Results of the Anterior Cruciate Ligament Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation

In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports.

In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports.

This is a single-center prospective randomized clinical trial with 112 patients diagnosed with anterior cruciate ligament rupture randomly allocated in four groups: single bundle with autologous bioabsorbable implant; single bundle with intrafix implant; double bundle with autologous bioabsorbable implant; double bundle with intrafix implant.

Primary outcome is graft ligamentization assessed in MRI images at 4-6 months

Inclusion Criteria:

isolated ACL injury for more than six weeks by physical examination and confirmed by magnetic resonance, adult non-elderly (18 to 60 years), nonobese (body mass index within the normal range)

Exclusion Criteria:

intraoperative complications requiring change in technique of reconstruction and / or anesthesia during surgery, patients undergoing cartilage piercing procedures ( such as microfractures) and / or meniscus suture, those with allergies to medications administered during anesthesia, surgery and / or post-operative patients with tourniquet time of more than two hours and patients who did not sign the consent form