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

Vita Care112 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

112

Conditions

Knee Injuries ACL Tear ACL Injury Sports Injury

Interventions

Surgical technique combined with a specific choice of the material for the ligament reconstructionOTHER

The surgical procedure is done as standard of care. The intervention is to randomize the participant into the study arms, which none of those has been proved yet to be a superior choice

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Instituto Vita

São Paulo, São Paulo, Brazil

RECRUITING

Outcomes

Primary Outcomes

Bone-graft integration

Bone-graft integration assessed in the MRI

Time frame: 4-6 months

Secondary Outcomes

Clinical scores

Knee laxity (KT1000, 0 to 5 mm range, higher scores = worse outcome), Objective and Subjective International Knee Documentation Committee (Objective IKDC: 0-100 range, higher scores = better outcomes; Subjective IKDC: A-D range; A = better outcomes) scores, Lysholm score (0-100 range, higher scores = better outcomes) and Tegner Activity Scale (0-10 range, higher scores = higher levels of physical activity/ competitive sport activity)

Time frame: 4-12 months

Retear

Retear of the reconstructed ACL

Time frame: Through study completion, an average of 2 years

Central Contacts

Instituto Vita

CONTACT

institutovita@institutovita.org.br

Wagner Castropil

CONTACT

castropil@institutovita.com.br

Data from ClinicalTrials.gov

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