Analysis Of Knee Joint Of Patients With Anterior Cruciate Ligament Injury Undergoing Physiotherapy After Two Different Surgical Techniques: A Randomized Clinical Trial.

May 4, 2026 updated by: Christiane Macedo, Universidade Estadual de Londrina

Analysis 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.

The objetive is compare knee joint stability, functional capacity, postural control, activation, and muscle strength of patients undergoing conventional Anterior Cruciate Ligament Reconstruction or the conventional Anterior Cruciate Ligament Reconstruction + Anterolateral Ligament Reconstruction technique of the knee, and rehabilitation for up to nine months. This project aims to include patients with ACL injuries already treated at the Knee Outpatient Clinic of the Hospital das Clínicas da UEL (HC-UEL), coordinated by the orthopedic physician Dr. Lucas da Fonseca Borghi, who has his master's degree related to this research project. Twenty patients between 18 and 50 years old, of both sexes, sedentary and/or active and/or athletes, diagnosed with unilateral injury of the Anterior Cruciate Ligament will be included. These patients will be evaluated, submitted to ACL surgery (conservative) or associated with ALL reconstruction and undergo rehabilitation with physiotherapy in conjunction with the extension project Sports Physiotherapy from Theory to Practice - Phase III (PROEX-UEL No 02675), coordinated by Prof. Dr. Christiane S. Guerino Macedo - advisor of this research. Expected results: It is expected that the group undergoing ACL + ALL reconstruction will present better knee joint stability, functional capacity, postural control, activation and muscle strength.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Christiane Macedo
  • Phone Number: +55 43 991015123
  • Email: chmacedo@uel.br

Study Contact Backup

Study Locations

  • Brazil
    • Paraná
      • Londrina, Paraná, Brazil, 86038-350
        • Recruiting
        • University Hospital of the State University of Londrina
        • Contact:
      • Londrina, Paraná, Brazil, 86041-263
        • Recruiting
        • State University of Londrina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 conventional ACL reconstruction with quadruple flexor tendons and conventional physiotherapy
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.
Procedure: Group 1 ACL reconstruction with quadruple flexor tendons and conventional physiotherapy
Group 1 will undergo conventional ACL reconstruction with quadruple flexor tendons (double gracilis and semitendinosus). All the participants will receive conventional physiotherapy.
Active Comparator: Group 2 (combined ACL + ALL reconstruction) and conventional physiotherapy
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.
Procedure: Group 2 ACL reconstruction with quadruple flexor tendons + ALL reconstruction
Group 2 will undergo conventional ACL reconstruction with quadruple flexor tendons (double gracilis and semitendinosus) + ALL reconstruction. All the participants will receive conventional physiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Articular Range of Motion
Time Frame: preoperative and postoperative (5, 15, 30, 60 and 120 days).
Assessment of hip and knee range of motion (Hip Internal Rotation Mobility and Lunge Test).
preoperative and postoperative (5, 15, 30, 60 and 120 days).
Functional Capacity
Time Frame: preoperative and postoperative (5, 15, 30, 60 and 120 days).
Lysholm Knee Scoring Scale: Eight questions, with closed answer alternatives, whose final result is expressed in nominal and ordinal form.
preoperative and postoperative (5, 15, 30, 60 and 120 days).
Isometric Muscle Strength
Time Frame: preoperative and postoperative (5, 15, 30, 60 and 120 days).
Dynamometer (SP MEDEOR/TECH), connecting it via Bluetooth to the My SP Tech application for verification to check the strength of knee flexors and extensors.
preoperative and postoperative (5, 15, 30, 60 and 120 days).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait through the GaitRite program
Time Frame: postoperative 5, 15, 30, 60 and 10 days.
Collection of spatiotemporal parameters related to the gait pattern in the pre and post-operative period using the GaitRite device. The GaitRite can help identify changes in knee loading, identify neuromuscular asymmetries, which may be caused by muscle weakness and identify movement patterns that may be causative of future injury or disability.
postoperative 5, 15, 30, 60 and 10 days.
Functional Tests
Time Frame: preoperative and postoperative (5, 15, 30, 60 and 120 days).
Star Excursion Balance Test: assess the dynamic stability of the lower limbs. The length of the participants' lower limbs will be measured to normalize the data obtained in each direction.
preoperative and postoperative (5, 15, 30, 60 and 120 days).
Analysis of postural control
Time Frame: preoperative and postoperative (5, 15, 30, 60 and 120 days).
Will be tested on the BIOMEC411 force platform. The main balance parameters based on the center of pressure (COP) will be computed: the COP ellipse area (A-COP in cm2), average COP oscillation velocity (VEL in cm/s) in the anteroposterior (A/P) and mediolateral (M/L) movement directions, COP oscillation amplitude (cm) in the anteroposterior (A/P) and mediolateral (M/L) directions, and COP oscillation frequency (Hz) in the anteroposterior (A/P) and mediolateral (M/L) directions. All these variables are computed by the program based on the equilibrium parameters that the platform generates.
preoperative and postoperative (5, 15, 30, 60 and 120 days).
Analysis of muscle activation by surface electromyography
Time Frame: preoperative and postoperative (5, 15, 30, 60 and 120 days).
The EMG signal will be captured with three pre-amplified active electrodes (gain: 1000) and filtered in a band-pass between 25 and 450 Hz, with a sampling frequency of 2000 Hz.
preoperative and postoperative (5, 15, 30, 60 and 120 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Estadual de Londrina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Actual)

February 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 11, 2025

First Submitted That Met QC Criteria

January 30, 2025

First Posted (Actual)

February 5, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6.955.081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Other researchers may contact us and request data from this research by email.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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