Analysis of Knee Joint of Patients with Anterior Cruciate Ligament Injury Undergoing Physiotherapy After Two Different Surgical Techniques: a Randomized Clinical Trial.

NCT ID: NCT06809920

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2027-12-01

Brief Summary

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.

Conditions

Anterior Cruciate Ligament (ACL) Tear; Anterior Cruciate Ligament Reconstruction Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Group 1 ACL reconstruction with quadruple flexor tendons and conventional physiotherapy

Intervention Type: 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 (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.

Group Type: ACTIVE_COMPARATOR

Group 2 ACL reconstruction with quadruple flexor tendons + ALL reconstruction

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Estadual de Londrina

OTHER

Sponsor Role: lead

Responsible Party

Christiane Macedo

Principal Investigator PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Christiane Macedo

Role: CONTACT

chmacedo@uel.br

+55 43 991015123

Caroline de Camargo

Role: CONTACT

caroline.coletti@uel.br

+55 43 996549698

Other Identifiers

6.955.081

Identifier Type: -

Identifier Source: org_study_id