Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
Same as current

Summary

Conditions
Anterior Cruciate Ligament Injuries
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Non-randomized 1:1 allocationMasking: Single (Outcomes Assessor)Masking Description: Outcomes Assessor will be blinded to the patient groupPrimary Purpose: Treatment

Participation Requirements

Age
Between 15 years and 25 years
Gender
Both males and females

Description

This study is a non-randomized clinical trial including 40 patients with anterior cruciate ligament injury who are undergoing surgery and will be allocated 1:1 to either isolated ACL reconstruction (control group) or ACL reconstruction combined with lateral extra-articular tenodesis (experimental gr...

This study is a non-randomized clinical trial including 40 patients with anterior cruciate ligament injury who are undergoing surgery and will be allocated 1:1 to either isolated ACL reconstruction (control group) or ACL reconstruction combined with lateral extra-articular tenodesis (experimental group). The principal outcome of this work is the sagittal and rotational knee laxity analysis and side-to-side and 2-year improvement. The secondary outcomes include graft failure (re-tears) and the patient-reported outcome measures (KOOS) at 2 years follow-up.

Tracking Information

NCT #
NCT04136990
Collaborators
Not Provided
Investigators
Study Director: João Espregueira-Mendes, MD, PhD Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence Principal Investigator: Renato Andrade Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence