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

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.

Full Title of Study: “Results of the Anterior Cruciate Ligament Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2022

Detailed Description

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

Interventions

  • Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction
    • 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

Arms, Groups and Cohorts

  • Active Comparator: Group A
    • single bundle technique with the use of bioabsorbable implants
  • Active Comparator: Group B
    • single bundle technique with the use of Bio-Intrafix
  • Active Comparator: Group C
    • double bundle technique with the use of bioabsorbable implants
  • Active Comparator: Group D
    • double bundle technique with the use of Bio-Intrafix

Clinical Trial Outcome Measures

Primary Measures

  • Bone-graft integration
    • Time Frame: 4-6 months
    • Bone-graft integration assessed in the MRI

Secondary Measures

  • Clinical scores
    • Time Frame: 4-12 months
    • 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)
  • Retear
    • Time Frame: Through study completion, an average of 2 years
    • Retear of the reconstructed ACL

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vita Care
  • Collaborator
    • Johnson & Johnson
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Wagner Castropil, Principal Investigator, Instituto Vita
  • Overall Contact(s)
    • Instituto Vita, institutovita@institutovita.org.br

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