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

Vita Care

Status: Unknown

Conditions: Knee Injuries; ACL Tear; Sports Injury; ACL Injury

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04550299

022

Details and patient eligibility

About

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 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

Enrollment: 112 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 4 patient groups

Group A

Active Comparator group

Description:

single bundle technique with the use of bioabsorbable implants

Treatment:

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

Group B

Active Comparator group

Description:

single bundle technique with the use of Bio-Intrafix

Treatment:

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

Group C

Active Comparator group

Description:

double bundle technique with the use of bioabsorbable implants

Treatment:

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

Group D

Active Comparator group

Description:

double bundle technique with the use of Bio-Intrafix

Treatment:

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