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

Not Applicable

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

• Registration Number: NCT04550299
• Lead Sponsor: Vita Care

Brief Summary

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.

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 Timeline

• Study Start: 2013-02-26
• Status Verified: 2020-09
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-08
• Last Update Submitted: 2020-09-08
• Study First Posted: 2020-09-16
• Last Update Posted: 2020-09-16
• Primary Completion: 2022-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Surgical technique combined with a specific choice of the material for the ligament reconstruction	double bundle technique with the use of bioabsorbable implants
Group B	Surgical technique combined with a specific choice of the material for the ligament reconstruction	single bundle technique with the use of Bio-Intrafix
Group A	Surgical technique combined with a specific choice of the material for the ligament reconstruction	single bundle technique with the use of bioabsorbable implants
Group D	Surgical technique combined with a specific choice of the material for the ligament reconstruction	double bundle technique with the use of Bio-Intrafix

Primary Outcome Measures

Name	Time	Method
Bone-graft integration	4-6 months	Bone-graft integration assessed in the MRI

Secondary Outcome Measures

Name	Time	Method
Clinical scores	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	Through study completion, an average of 2 years	Retear of the reconstructed ACL

Trial Locations

Locations (1)

Instituto Vita; 🇧🇷 Sao Paulo, SP, Brazil