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

NCT06809920 | Not Yet Recruiting

• 1 other identifier: 6.955.081
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Keywords

Knee; Knee Injuries; Anterior Cruciate Ligament Reconstruction; Physiotherapy

Outcome Measures

Primary Outcomes (3)

• Articular Range of Motion

  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

  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

  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 Outcomes (4)

• Gait through the GaitRite program

  postoperative 5, 15, 30, 60 and 10 days.

• Functional Tests

  preoperative and postoperative (5, 15, 30, 60 and 120 days).

• Analysis of postural control

  preoperative and postoperative (5, 15, 30, 60 and 120 days).

• Analysis of muscle activation by surface electromyography

  preoperative and postoperative (5, 15, 30, 60 and 120 days).

Study Arms (2)

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

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.

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

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

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.

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

Interventions

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 1 conventional ACL reconstruction with quadruple flexor tendons and 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.

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Universidade Estadual de Londrina: lead

MeSH Terms

Conditions

Lacerations; Knee Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries; Leg Injuries

Central Study Contacts

Christiane Macedo

CONTACT

+55 43 991015123; chmacedo@uel.br

Caroline de Camargo

CONTACT

+55 43 996549698; caroline.coletti@uel.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator PhD

Model Details: Participants will undergo, in a previously randomized manner, two surgical techniques for reconstruction of the anterior cruciate ligament of the knee. The two techniques differ in the preparation of the graft. Group 1: ACL reconstruction surgery with the conventional technique or, Group 2: Conventional reconstruction surgery of the Anterior Cruciate Ligament + Reconstruction of the Anterolateral Ligament of the knee. The literature indicates that both techniques have good results, but the differences during the rehabilitation process are still unknown. Both groups will be evaluated and reevaluated in the same way. Also, both groups will undergo the same rehabilitation protocol with manual therapy, physical resources (heat, cold, electrotherapy), kinesiotherapy, and isokinetic exercises.

Study Record Dates

• First Submitted: January 11, 2025
• First Posted: February 5, 2025
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR