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.

Study Overview

• Status: Recruiting
• Conditions: Knee Injuries; ACL Injury; Sports Injury; ACL Tear
• Intervention / Treatment: Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction

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

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Instituto Vita; Email: institutovita@institutovita.org.br
• Study Contact Backup: Name: Wagner Castropil; Email: castropil@institutovita.com.br

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 01239-040
      • Recruiting
      • Instituto Vita
      • Contact: Wagner Castropil, PhD; Email: castropil@institutovita.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; single bundle technique with the use of bioabsorbable implants	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
Active Comparator: Group B; single bundle technique with the use of Bio-Intrafix	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
Active Comparator: Group C; double bundle technique with the use of bioabsorbable implants	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
Active Comparator: Group D; double bundle technique with the use of Bio-Intrafix	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone-graft integration	Bone-graft integration assessed in the MRI	4-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	4-12 months
Retear	Retear of the reconstructed ACL	Through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Vita Care
• Collaborators: Johnson & Johnson
• Investigators: Principal Investigator: Wagner Castropil, Instituto Vita

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2013
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Anterior Cruciate Ligament Injuries; Athletic Injuries; Knee Injuries
• Other Study ID Numbers: 022 (ITCC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No