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Analysis Of Knee Joint Of Patients With Anterior Cruciate Ligament Injury Undergoing Physiotherapy After Two Different Surgical Techniques: A Randomized Clinical Trial.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06809920
Enrollment
26
Registered
2025-02-05
Start date
2025-02-01
Completion date
2027-12-01
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Knee, Knee Injuries, Anterior Cruciate Ligament Reconstruction, Physiotherapy

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.

Interventions

PROCEDUREGroup 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.

PROCEDUREGroup 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.

Sponsors

Universidade Estadual de Londrina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Articular Range of MotionPreoperative 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)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 StrengthPreoperative 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

MeasureTime frameDescription
Gait through the GaitRite programPreoperative 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.
Functional TestsPostoperative 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.
Analysis of postural controlPreoperative 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.
Analysis of muscle activation by surface electromyographyPreoperative 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.
Isokinetic AssessmentPreoperative 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).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026