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

Universidade Estadual de Londrina

Status: Not yet enrolling

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

Treatments: Procedure: Group 2 ACL reconstruction with quadruple flexor tendons + ALL reconstruction; Procedure: Group 1 ACL reconstruction with quadruple flexor tendons and conventional physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06809920

6.955.081

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

20 participants in 2 patient groups

Group 1 conventional ACL reconstruction with quadruple flexor tendons and conventional physiotherapy

Active Comparator group

Description:

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.

Treatment:

Procedure: Group 1 ACL reconstruction with quadruple flexor tendons and conventional physiotherapy

Group 2 (combined ACL + ALL reconstruction) and conventional physiotherapy

Active Comparator group

Description:

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.

Treatment:

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