Anterior Cruciate Ligament (ACL) TearNCT06809920
Analysis Of Knee Joint Of Patients With Anterior Cruciate Ligament Injury Undergoing Physiotherapy After Two Different Surgical Techniques: A Randomized Clinical Trial.
A study testing Group 1 ACL reconstruction with quadruple flexor tendons and conventional physiotherapy and Group 2 ACL reconstruction with quadruple flexor tendons + ALL reconstruction in people with Anterior Cruciate Ligament (ACL) Tear and Anterior Cruciate Ligament Reconstruction Rehabilitation, run by Universidade Estadual de Londrina at 2 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament (ACL) Tear, Anterior Cruciate Ligament Reconstruction Rehabilitation
- What is being tested?
- Group 1 ACL reconstruction with quadruple flexor tendons and conventional physiotherapy and Group 2 ACL reconstruction with quadruple flexor tendons + ALL reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Feb 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
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 locations and contacts
2 sites in 1 country.
Brazil2 sites
university hospital of the State University of Londrina
Londrina, Paraná, 86038-350
State University of Londrina
Londrina, Paraná, 86041-263
About this study
Official title: 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.
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
- Being tested
- Group 1 ACL reconstruction with quadruple flexor tendons and conventional physiotherapy, Group 2 ACL reconstruction with quadruple flexor tendons + ALL reconstruction
- Keywords
- Knee, Knee Injuries, Anterior Cruciate Ligament Reconstruction, Physiotherapy
- Medical subject headings
- Lacerations, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 ACL reconstruction with quadruple flexor tendons and conventional physiotherapyProcedure or surgery
Group 1 will undergo conventional ACL reconstruction with quadruple flexor tendons (double gracilis and semitendinosus). All the participants will receive conventional physiotherapy.
Group 2 ACL reconstruction with quadruple flexor tendons + ALL reconstructionProcedure or surgery
Group 2 will undergo conventional ACL reconstruction with quadruple flexor tendons (double gracilis and semitendinosus) + ALL reconstruction. All the participants will receive conventional physiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Group 2 ACL reconstruction with quadruple flexor tendons + ALL reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Articular Range of Motion
Assessment of hip and knee range of motion (hip internal rotation mobility, lunge test, and flexion/extension).
Measured: 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.
Measured: 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.
Measured: Preoperative and postoperative (2, 4, 6, and 9 months).
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Preoperative and postoperative 6 and 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Feb 2025
- Primary completion1 Jun 2026
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament (ACL) TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christiane Macedo, Universidade Estadual de Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809920
- Sponsor's protocol ID
- 6.955.081
- Status last verified
- Jun 2026
- First submitted
- 11 Jan 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Other researchers may contact us and request data from this research by email.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06809920
- Acronym / sponsor ID
- 6.955.081
- Conditions
- Anterior Cruciate Ligament (ACL) Tear, Anterior Cruciate Ligament Reconstruction Rehabilitation
- Keywords
- Knee, Knee Injuries, Anterior Cruciate Ligament Reconstruction, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 conventional ACL reconstruction with quadruple flexor tendons and conventional physiotherapy | Active comparator | Procedure: Group 1 ACL reconstruction with quadruple flexor tendons and conventional physiotherapyThis 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. |
| Group 2 (combined ACL + ALL reconstruction) and conventional physiotherapy | Active comparator | Procedure: Group 2 ACL reconstruction with quadruple flexor tendons + ALL reconstructionGroup 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1 ACL reconstruction with quadruple flexor tendons and conventional physiotherapyGroup 1 will undergo conventional ACL reconstruction with quadruple flexor tendons (double gracilis and semitendinosus). All the participants will receive conventional physiotherapy. | Procedure or surgery | Group 1 conventional ACL reconstruction with quadruple flexor tendons and conventional physiotherapy |
| Group 2 ACL reconstruction with quadruple flexor tendons + ALL reconstructionGroup 2 will undergo conventional ACL reconstruction with quadruple flexor tendons (double gracilis and semitendinosus) + ALL reconstruction. All the participants will receive conventional physiotherapy. | Procedure or surgery | Group 2 (combined ACL + ALL reconstruction) and conventional physiotherapy |
Primary outcome
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.
5 secondary outcomes
Gait through the GaitRite program
Time frame: Preoperative and postoperative (5 and 15 days; 1, 2, 4, 6, and 9 months).
Functional Tests
Time frame: Postoperative 4, 6, and 9 months.
Analysis of postural control
Time frame: Preoperative and postoperative (1, 2, 4, 6, and 9 months).
Analysis of muscle activation by surface electromyography
Time frame: Preoperative and postoperative (5 and 15 days; 1, 2, 4, 6, and 9 months).
Isokinetic Assessment
Time frame: Preoperative and postoperative 6 and 9 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Yes. Other researchers may contact us and request data from this research by email.
Related trials for Anterior Cruciate Ligament (ACL) Tear
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 ACL reconstruction with quadruple flexor tendons and conventional physiotherapy and Group 2 ACL reconstruction with quadruple flexor tendons + ALL reconstruction in people with Anterior Cruciate Ligament (ACL) Tear and Anterior Cruciate Ligament Reconstruction Rehabilitation, run by Universidade Estadual de Londrina at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Articular Range of Motion (time frame: Preoperative and postoperative (5 and 15 days; 1, 2, 4, 6, and 9 months).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.