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Knee Joint Stability and Function After ACL Surgery Techniques in Adults

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What is being tested

Group 1 ACL reconstruction with quadruple flexor tendons and conventional physiotherapy

+ Group 2 ACL reconstruction with quadruple flexor tendons + ALL reconstruction

Procedure
Who is being recruted

Knee Injuries+1

+ Leg Injuries

+ Wounds and Injuries

From 18 to 50 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2025
See protocol details

Summary

Principal SponsorUniversidade Estadual de Londrina
Study ContactChristiane MacedoMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial focuses on comparing two surgical techniques to treat injuries in the Anterior Cruciate Ligament (ACL) of the knee. It aims to determine which method provides better outcomes in terms of knee stability, movement ability, balance, and muscle strength. The study involves patients from 18 to 50 years old, both sedentary and active, who have a single ACL injury. The trial is significant because it may identify a more effective surgical technique, potentially improving recovery and physical performance for individuals with ACL injuries. Participants in the study will undergo either the conventional ACL surgery or a combination of ACL and Anterolateral Ligament (ALL) reconstruction. After surgery, they will receive rehabilitation through physiotherapy for up to nine months. This rehabilitation is guided by professionals experienced in sports physiotherapy. The study evaluates the improvements in knee stability, functional capacity, and other key aspects. While there are no specific risks mentioned, the study's results could lead to enhanced treatment options for ACL injuries.

Official TitleAnalysis of Knee Joint Stability, Functional Capacity, Postural Control, Activation and Muscle Strength of Patients with Anterior Cruciate Ligament Injury Undergoing Physiotherapy After Two Different Surgical Techniques: a Randomized Clinical Trial.
NCT06809920
Principal SponsorUniversidade Estadual de Londrina
Study ContactChristiane MacedoMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Knee InjuriesLeg InjuriesWounds and InjuriesLacerations

Criteria

Inclusion Criteria: - participants with 18 to 50 years old; - both sexes; - sedentary; -active; - athletes; - diagnosed unilateral ACL injury; - patients residing in the city of Londrina - PR. Exclusion Criteria: - BMI (Body Mass Index) above 35 kg/m2; - multidirectional ligament laxity; - associated multiligament injury (PCL and posterolateral corner); - previous or current lower limb fractures; - previous ACL reconstruction (revision); - signs of osteoarthritis; - indication for meniscus suture; - neurological disease; - pregnant women; - heart disease; - previous lower limb surgeries.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
This surgery is performed with the aid of videoarthroscopy in a minimally invasive manner. The procedure begins with the collection of the muscle graft that will be used for ACL reconstruction. The semitendinosus and gracilis muscles, also known as flexor tendons, will be used. All the participants will receive conventional physiotherapy with rehabilitation protocol with manual therapy, physical resources (heat, cold, electrotherapy), kinesiotherapy, and isokinetic exercises. All participants will be evaluated and re-evaluated in the same way.

Group II

Active Comparator
Group 2 will undergo conventional ACL + ALL reconstruction in a similar manner to group 1 with quadruple flexor graft (triple semitendinosus and single gracilis). For combined ACL + ALL reconstruction, it is performed through a conventional tibial tunnel with a 55-degree angulation guide and a diameter defined by the thickness of the graft. All the participants will receive conventional physiotherapy with rehabilitation protocol with manual therapy, physical resources (heat, cold, electrotherapy), kinesiotherapy, and isokinetic exercises. All participants will be evaluated and re-evaluated in the same way.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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