Skip to main content
Clinical Trials/NCT06809920
NCT06809920Active, not recruitingNot Applicable

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.

Universidade Estadual de Londrina2 sites in 1 country26 target enrollmentStarted: February 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
26
Locations
2
Primary Endpoint
Articular Range of Motion

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

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

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.

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

Outcomes

Primary Outcomes

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).

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.

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

  • Gait through the GaitRite program(Preoperative and postoperative (5 and 15 days; 1, 2, 4, 6, and 9 months).)
  • Functional Tests(Postoperative 4, 6, and 9 months.)
  • Analysis of postural control(Preoperative and postoperative (1, 2, 4, 6, and 9 months).)
  • Analysis of muscle activation by surface electromyography(Preoperative and postoperative (5 and 15 days; 1, 2, 4, 6, and 9 months).)
  • Isokinetic Assessment(Preoperative and postoperative 6 and 9 months.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christiane Macedo

Principal Investigator PhD

Universidade Estadual de Londrina

Study Sites (2)

Loading locations...

Similar Trials