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NCT Number: NCT06809920

Analysis Of Knee Joint 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.

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Key information

Conditions

Anterior Cruciate Ligament (ACL) Tear Anterior Cruciate Ligament Reconstruction Rehabilitation Knee Injuries Lacerations Leg Injuries Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State University of Londrina, Londrina, Paraná, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group 1 ACL reconstruction with quadruple flexor tendons and conventional physiotherapy

Procedure

Group 1 will undergo conventional ACL reconstruction with quadruple flexor tendons (double gracilis and semitendinosus). All the participants will receive conventional physiotherapy.

Group 2 ACL reconstruction with quadruple flexor tendons + ALL reconstruction

Procedure

Group 2 will undergo conventional ACL reconstruction with quadruple flexor tendons (double gracilis and semitendinosus) + ALL reconstruction. All the participants will receive conventional physiotherapy.

Primary outcomes

  1. Articular Range of Motion

    Time frame: Preoperative and postoperative (5 and 15 days; 1, 2, 4, 6, and 9 months).

    Assessment of hip and knee range of motion (hip internal rotation mobility, lunge test, and flexion/extension).

  2. Functional Capacity (Questionnaires)

    Time frame: Preoperative and postoperative (5 and 15 days; 1, 2, 4, 6, and 9 months).

    Lysholm Scale: Eight questions, with closed answer alternatives, whose final result is expressed in nominal and ordinal form.

    IKDC: assesses symptoms, function, and sports activity on a scale of 0 to 100 points.

    ACLRSI: quantifies psychological readiness for return to sport on a scale of 0 to 100 points.

  3. Isometric Muscle Strength

    Time frame: Preoperative and postoperative (2, 4, 6, and 9 months).

    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.

Secondary outcomes

  1. Gait through the GaitRite program

    Time frame: Preoperative and postoperative (5 and 15 days; 1, 2, 4, 6, and 9 months).

    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.

  2. Functional Tests

    Time frame: Postoperative 4, 6, and 9 months.

    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.

    Hop test: will require participants to perform a maximum distance jump on the evaluated limb.

    Crossover hop: will require participants to perform three consecutive jumps, alternately crossing a central line of 15 cm.

  3. Analysis of postural control

    Time frame: Preoperative and postoperative (1, 2, 4, 6, and 9 months).

    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.

  4. Analysis of muscle activation by surface electromyography

    Time frame: Preoperative and postoperative (5 and 15 days; 1, 2, 4, 6, and 9 months).

    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.

  5. Isokinetic Assessment

    Time frame: Preoperative and postoperative 6 and 9 months.

    The isokinetic assessment will be conducted using the Biodex Multi-Joint System 3 dynamometer (Biodex Medical Systems, Shirley, NY, USA), following a standardized warm-up on a cycle ergometer. Muscle performance will be tested in concentric mode at angular velocities of 60, 180, and 300°/s, with peak torque recorded throughout the total range of motion to determine the hamstring/quadriceps muscle balance ratio (I:Q).

Sponsors and collaborators

Lead sponsor

Universidade Estadual de Londrina

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 5, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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