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

NCT04550299 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2020-09-16

No results posted yet for this study

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.

Conditions

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

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

Sponsors & Collaborators

Principal Investigators

  • Wagner Castropil · Instituto Vita

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-26
Primary Completion
2022-12-01
Completion
2023-12-01

Countries

  • Brazil

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04550299 on ClinicalTrials.gov