NCT04550299

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Vita Care · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Knee Injuries
• ACL Tear
• ACL Injury
• Sports Injury

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-02-26
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2020-09-16
• Last updated: 2020-09-16

Locations

1 site across 1 country: Brazil