An interventional study of Group 1 ACL reconstruction with quadruple flexor tendons and conventional physiotherapy and Group 2 ACL reconstruction with quadruple flexor tendons + ALL reconstruction in Anterior Cruciate Ligament (ACL) Tear and Anterior Cruciate Ligament Reconstruction Rehabilitation, sponsored by Universidade Estadual de Londrina. Active, not recruiting at 2 sites in Brazil. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Universidade Estadual de Londrina · Not applicable, Interventional, and Treatment
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.
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's enrollment of 26 is below the median of 65 across 128 interventional studies indexed under Lacerations.
Browse Lacerations studies →Universidade Estadual de Londrina is the lead sponsor of 49 studies on the registry; 4 are open to participants now.
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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: - (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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
Group 1 will undergo conventional ACL reconstruction with quadruple flexor tendons (double gracilis and semitendinosus). All the participants will receive conventional physiotherapy.
Group 2 will undergo conventional ACL reconstruction with quadruple flexor tendons (double gracilis and semitendinosus) + ALL reconstruction. All the participants will receive conventional physiotherapy.
Articular Range of Motion
Assessment of hip and knee range of motion (hip internal rotation mobility, lunge test, and flexion/extension).
Time frame: Preoperative and postoperative (5 and 15 days; 1, 2, 4, 6, and 9 months).
Functional Capacity (Questionnaires)
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.
Time frame: Preoperative and postoperative (5 and 15 days; 1, 2, 4, 6, and 9 months).
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.
Time frame: Preoperative and postoperative (2, 4, 6, and 9 months).
Gait through the GaitRite program
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.
Time frame: Preoperative and postoperative (5 and 15 days; 1, 2, 4, 6, and 9 months).
Functional Tests
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.
Time frame: Postoperative 4, 6, and 9 months.
Analysis of postural control
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.
Time frame: Preoperative and postoperative (1, 2, 4, 6, and 9 months).
Analysis of muscle activation by surface electromyography
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.
Time frame: Preoperative and postoperative (5 and 15 days; 1, 2, 4, 6, and 9 months).
Isokinetic Assessment
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).
Time frame: Preoperative and postoperative 6 and 9 months.
Plan to share: Yes — Other researchers may contact us and request data from this research by email.
Supporting information: Clinical study report
No publications or documents are linked to this record.
Ran from Feb 2025 to primary completion in Jun 2026, 16 months.
Of 46 non-industry interventional studies with no phase under Lacerations, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 72. This study's 16 months is below that.
Counting every sponsor, half of 50 studies reached it within 19 months; a quarter within 12 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Universidade Estadual de Londrina