Genu VarumNCT06606964
The Influence of the Lower Limb Components on Genu Varum in Football Players
An observational study of Genu Varum and Football Players, run by Tuba Melekoğlu at 1 site in Turkey (Türkiye).
Trial summary
Objectives: To evaluate lower extremity alignments in football players with and without genu varum using magnetic resonance imaging (MRI), to determine the mechanisms underlying malalignment and the factors contributing to it. Read more about this study
- Who is it for?
- Ages 16 to 19 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Genu Varum, Football Players
- What is being tested?
- Magnetic Resonance Imaging and Isokinetic Strength
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 19 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: The study participants were selected from otherwise healthy football players aged 16-19 who currently play for a professional football club, have at least five years of football experience, train five days a week, and participate in official matches.
Who may be able to join
- Healthy football players who currently play for a professional football club
- Aged 16-19
- Have at least five years of football experience
- Train five days a week
- Participating in official matches.
Who cannot join
- History of musculoskeletal disease
- History of postural disorders
- History of previous surgery for lower extremity sports injuries
- History of fractures of the long bones of the lower extremity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Faculty of Sport Sciences
Antalya, Antalya, 07070
About this study
Official title: The Influence of the Lower Limb Components on Genu Varum in Football Players: a Full Leg Length Magnetic Resonance Imaging Study
Objectives: To evaluate lower extremity alignments in football players with and without genu varum using magnetic resonance imaging (MRI), to determine the mechanisms underlying malalignment and the factors contributing to it.
Methods: This is a prospective case-control study with football players with/without lower extremity malalignment. Full-length lower extremity MRI was used to evaluate the lower extremity alignment parameters. In addition, the isokinetic strength of the concentric knee extensor-flexor and concentric hip abductor-adductor muscles was measured using an isokinetic dynamometer at two different angular velocities: 60˚/sec and 180˚/sec. The investigators created a logistic regression model to investigate whether the alignment parameters used to evaluate lower extremity alignment in football players are risk factors for the development of genu varum.
Read the detailed description
Genu varum deformity is a common condition among football players, occurring in 73% of cases . Previous studies have shown that football players are at a higher risk of developing genu varum than athletes in other sports . Genu varum can have a negative impact on an athlete\'s physical abilities by disrupting static and dynamic balance through alterations in the gravitational axis of the lower extremities. In addition, genu varum can damage the tibiofemoral articular cartilage, increasing the risk of knee osteoarthritis later in life . It is also associated with several intra-articular pathologies, including meniscal lesions, anterior knee pain, and anterior cruciate ligament injuries . Therefore, it is important to understand the cause of this deformity and take protective-corrective measures for football players.
In recent years, researchers have studied the relationship between genu varum and football participation. Researchers have used various methods, including the caliper, goniometer, and photographic technique, to analyze deformities. However, these methods have limitations, making it difficult to examine etiological factors and differences in anthropometric components . In a study conducted by Colyn, Arnout, Verhaar and Bellemans 6, a comparison was made between football players and other athletes and non-athletes using digital radiology measurements. The findings indicated that male football players exhibited genu varum, with the proximal tibia identified as the primary factor determining this. Similarly, Krajnc and Drobnič studied lower limb alignment in asymptomatic adult professional football players and found that the proximal tibia was the source of varus deformity. However, it has been suggested that additional research is required to fully comprehend the involved mechanisms. Furthermore, Witvrouw, Danneels, Thijs, Cambier and Bellemans 9proposed that an imbalanced strength distribution between the adductor and abductor muscles may result in genu varum in football players. This is because kicking, a frequent activity in football, often strengthens the adductor muscles, which can alter the average adductor/abductor strength ratio. However, the authors note that no data on the adductor/abductor strength of football players is available in the literature. They suggest further research to address this knowledge gap.
Asymmetrical movements in football, resulting from the difference between the kicking and supporting legs, may lead to different mechanisms causing genu varum formation in the dominant and non-dominant legs. It is crucial to acknowledge that not all football players exhibit varus knee alignment. Consequently, in order to ascertain the mechanisms that contribute to the formation of genu varum, it is essential to conduct a comparative analysis between football players exhibiting and those lacking a varus deformity. This comparison can assist in identifying the mechanisms that cause genu varum in football players and the factors likely to contribute to these mechanisms. The study had three objectives: (i) to evaluate lower extremity alignments in football players with and without genu varum using magnetic resonance imaging (MRI), (ii) to determine the mechanisms underlying malalignment and the factors contributing to it; and (iii) to investigate the relationship between lower extremity alignment and isokinetic strength.
- Conditions
- Genu Varum, Football Players
- Being tested
- Magnetic Resonance Imaging, Isokinetic Strength
- Keywords
- Genu varum, Knee joint, Mechanical axis deviation, Isokinetic strength, Football players
- Medical subject headings
- Genu Varum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDiagnostic test
The MRI examinations were conducted using a 1.5 Tesla closed MRI system with a body coil and spine coil. The participants\' knees were positioned in full extension and their feet were in a neutral position during imaging. The scan was performed from the anterior superior iliac spine to the tip of the toes, and both legs were included in the field of view
Isokinetic StrengthOther
The strength of the concentric knee extensor-flexor and concentric hip abductor-adductor muscles was measured using an isokinetic dynamometer at two different angular velocities: 60˚/sec and 180˚/sec. Three repetitions were performed at 60˚/sec, and five repetitions were performed at 180˚/sec. To calculate the H/Q ratio, we divided the peak concentric torque of the hamstrings by that of the quadriceps during the same contraction velocity. Similarly, to determine the Add/Abd ratio, we divided the peak concentric torque of the adductors by that of the abductors during the same contraction velocity
| Study group | Role | What they receive |
|---|---|---|
| Football players with genu varum | Football players with genu varum leg alignment Receives: Diagnostic Test: Magnetic Resonance Imaging; Other: Isokinetic Strength | |
| Football players without genu varum | Football players with normal lower extremity alignment Receives: Diagnostic Test: Magnetic Resonance Imaging; Other: Isokinetic Strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical axis deviation (MAD)
The mechanical axis is a line connecting the center of the femoral head to the center of the ankle (center of the dome of the talus). A line was drawn from the center of the femoral head to the center of the ankle and the intersection of this line with the knee joint line was marked. The perpendicular distance from this intersection point to the center of the patella was measured as MAD.
Measured: From enrollment to the end of measurements at 3 weeks
Femoral anteversion (FA)
On the axial images of the hip/pelvis covering the femoral head and neck, a line is drawn between the center of the femoral head and center of the femoral neck to calculate the uncorrected femoral anteversion angle. To correct for distal femoral rotation, another line is drawn along the posterior border of the femoral condyles to calculate the angle. Positive degrees between the femoral neck and the distal femoral axis are called femoral antetorsion; negative values were considered as femoral retrotorsion.
Measured: From enrollment to the end of measurements at 3 weeks
Medial proximal tibial angle (MPTA)
The MPTA was defined as the medial angle between the proxsimal tibial joint line and the mechanical axis of the tibia. The proximal joint orientation line of tibia was drawn. A line was also drawn from the midpoint of the ankle to the midpoint of the knee on the tibial joint line. The angle between these two lines was measured.
Measured: From enrollment to the end of measurements at 3 weeks
Tibial torsion (TT)
Proximal tibial axis (PTA) was placed along the posterior cortex of the tibial head at the level of condyls proximal to the fibular head. Distal tibial axis (DTA) was placed to the articular aspects of the medial and the lateral malleolus below the talar surface. The tibial torsion was calculated as the angle between the PTA and the DTA.
Measured: From enrollment to the end of measurements at 3 weeks
Tibial tubercle-trochlear groove (TT-TG) distance
Firstly, transverse image that depicted a complete cartilaginous trochlea was used to determine the deepest point within the trochlear groove. A line was drawn through the deepest point of the trochlear groove, perpendicular to the posterior condylar tangent. Another line was drawn in parallel to the trochlear line through the most anterior portion of the tibial tubercle. Tibial tuberosity-trochlear groove distance was measured as the distance between these 2 lines.
Measured: From enrollment to the end of measurements at 3 weeks
Tibial tubercle-posterior cruciate ligament (TT-PCL)
The TT-PCL distance was measured on axial images between the patellar tendon insertion midpoint and the medial border of the posterior cruciate ligament at its tibial insertion, parallel to the dorsal tibia condylar line.
Measured: From enrollment to the end of measurements at 3 weeks
Joint line convergence angle (JLCA)
The mechanical axis line of femur was drawn, and then the knee joint line in the frontal plane was determined. The angle between these two lines was measured.
Measured: From enrollment to the end of measurements at 3 weeks
Hip-knee-ankle angle (HKA)
The measurement was taken of the angle formed between the mechanical axis of the femur and tibia.
Measured: From enrollment to the end of measurements at 3 weeks
Mechanical lateral distal femoral angle (mLDFA)
The distal joint orientation line of femur was drawn. A second line was drawn from the center of hip to the knee\'s midpoint at the femoral knee joint line (femoral mechanical axis). The angle between these two lines was measured.
Measured: From enrollment to the end of measurements at 3 weeks
Quadriceps femoris angle (Q angle)
The angle between the lines connecting the anterior superior iliac spine (ASIS) to the midpoint of the patella, and from there to the tibial tubercle was measured.
Measured: From enrollment to the end of measurements at 3 weeks
Secondary outcomes (1)
Isokinetic strength
The strength of the concentric knee extensor-flexor and concentric hip abductor-adductor muscles was measured using an isokinetic dynamometer at two different angular velocities: 60˚/sec and 180˚/sec.
Measured: From enrollment to the end of measurements at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Dec 2021
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Genu VarumStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuba Melekoğlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tuba Melekoğlu, Akdeniz University
- Investigators
- Tuba Melekoglu, Phd, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606964
- Sponsor's protocol ID
- KAEK-917
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during the current study will be available upon request from corresponder author Tuba Melekoğlu
Publications
Asadi K, Mirbolook A, Heidarzadeh A, Mardani Kivi M, Emami Meybodi MK, Rouhi Rad M. Association of Soccer and Genu Varum in Adolescents. Trauma Mon. 2015 May;20(2):e17184. doi: 10.5812/traumamon.17184. Epub 2015 May 25.
PubMed 26290852Isin A, Kose O, Ak E, Emir Yetim E, Cevikol C, Melekoglu T. The influence of the lower limb components on genu varum in football players: a full leg length magnetic resonance imaging study. BMC Sports Sci Med Rehabil. 2025 Feb 25;17(1):25. doi: 10.1186/s13102-025-01075-9.
PubMed 40001230
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Lower Limb Components on Genu Varum in Football Players: a Full Leg Length Magnetic Resonance Imaging Study
- ClinicalTrials.gov ID
- NCT06606964
- Acronym / sponsor ID
- KAEK-917
- Conditions
- Genu Varum, Football Players
- Keywords
- Genu varum, Knee joint, Mechanical axis deviation, Isokinetic strength, Football players
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Tuba MelekoğluUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 23 Sep 2024 (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.
Objectives: To evaluate lower extremity alignments in football players with and without genu varum using magnetic resonance imaging (MRI), to determine the mechanisms underlying malalignment and the factors contributing to it.
Methods: This is a prospective case-control study with football players with/without lower extremity malalignment. Full-length lower extremity MRI was used to evaluate the lower extremity alignment parameters. In addition, the isokinetic strength of the concentric knee extensor-flexor and concentric hip abductor-adductor muscles was measured using an isokinetic dynamometer at two different angular velocities: 60˚/sec and 180˚/sec. The investigators created a logistic regression model to investigate whether the alignment parameters used to evaluate lower extremity alignment in football players are risk factors for the development of genu varum.
Detailed description
Genu varum deformity is a common condition among football players, occurring in 73% of cases . Previous studies have shown that football players are at a higher risk of developing genu varum than athletes in other sports . Genu varum can have a negative impact on an athlete\'s physical abilities by disrupting static and dynamic balance through alterations in the gravitational axis of the lower extremities. In addition, genu varum can damage the tibiofemoral articular cartilage, increasing the risk of knee osteoarthritis later in life . It is also associated with several intra-articular pathologies, including meniscal lesions, anterior knee pain, and anterior cruciate ligament injuries . Therefore, it is important to understand the cause of this deformity and take protective-corrective measures for football players.
In recent years, researchers have studied the relationship between genu varum and football participation. Researchers have used various methods, including the caliper, goniometer, and photographic technique, to analyze deformities. However, these methods have limitations, making it difficult to examine etiological factors and differences in anthropometric components . In a study conducted by Colyn, Arnout, Verhaar and Bellemans 6, a comparison was made between football players and other athletes and non-athletes using digital radiology measurements. The findings indicated that male football players exhibited genu varum, with the proximal tibia identified as the primary factor determining this. Similarly, Krajnc and Drobnič studied lower limb alignment in asymptomatic adult professional football players and found that the proximal tibia was the source of varus deformity. However, it has been suggested that additional research is required to fully comprehend the involved mechanisms. Furthermore, Witvrouw, Danneels, Thijs, Cambier and Bellemans 9proposed that an imbalanced strength distribution between the adductor and abductor muscles may result in genu varum in football players. This is because kicking, a frequent activity in football, often strengthens the adductor muscles, which can alter the average adductor/abductor strength ratio. However, the authors note that no data on the adductor/abductor strength of football players is available in the literature. They suggest further research to address this knowledge gap.
Asymmetrical movements in football, resulting from the difference between the kicking and supporting legs, may lead to different mechanisms causing genu varum formation in the dominant and non-dominant legs. It is crucial to acknowledge that not all football players exhibit varus knee alignment. Consequently, in order to ascertain the mechanisms that contribute to the formation of genu varum, it is essential to conduct a comparative analysis between football players exhibiting and those lacking a varus deformity. This comparison can assist in identifying the mechanisms that cause genu varum in football players and the factors likely to contribute to these mechanisms. The study had three objectives: (i) to evaluate lower extremity alignments in football players with and without genu varum using magnetic resonance imaging (MRI), (ii) to determine the mechanisms underlying malalignment and the factors contributing to it; and (iii) to investigate the relationship between lower extremity alignment and isokinetic strength.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Football players with genu varum | – | Diagnostic Test: Magnetic Resonance Imaging, Other: Isokinetic StrengthFootball players with genu varum leg alignment |
| Football players without genu varum | – | Diagnostic Test: Magnetic Resonance Imaging, Other: Isokinetic StrengthFootball players with normal lower extremity alignment |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study participants were selected from otherwise healthy football players aged 16-19 who currently play for a professional football club, have at least five years of football experience, train five days a week, and participate in official matches.
Key inclusion criteria (5 listed)
- Healthy football players who currently play for a professional football club
- Aged 16-19
- Have at least five years of football experience
- Train five days a week
- Participating in official matches.
Key exclusion criteria (4 listed)
- History of musculoskeletal disease
- History of postural disorders
- History of previous surgery for lower extremity sports injuries
- History of fractures of the long bones of the lower extremity
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 |
|---|---|---|
| Magnetic Resonance ImagingThe MRI examinations were conducted using a 1.5 Tesla closed MRI system with a body coil and spine coil. The participants\' knees were positioned in full extension and their feet were in a neutral position during imaging. The scan was performed from the anterior superior iliac spine to the tip of the toes, and both legs were included in the field of view | Diagnostic test | Football players with genu varum, Football players without genu varum |
| Isokinetic StrengthThe strength of the concentric knee extensor-flexor and concentric hip abductor-adductor muscles was measured using an isokinetic dynamometer at two different angular velocities: 60˚/sec and 180˚/sec. Three repetitions were performed at 60˚/sec, and five repetitions were performed at 180˚/sec. To calculate the H/Q ratio, we divided the peak concentric torque of the hamstrings by that of the quadriceps during the same contraction velocity. Similarly, to determine the Add/Abd ratio, we divided the peak concentric torque of the adductors by that of the abductors during the same contraction velocity | Other | Football players with genu varum, Football players without genu varum |
Primary outcome
Mechanical axis deviation (MAD)
Time frame: From enrollment to the end of measurements at 3 weeks
The mechanical axis is a line connecting the center of the femoral head to the center of the ankle (center of the dome of the talus). A line was drawn from the center of the femoral head to the center of the ankle and the intersection of this line with the knee joint line was marked. The perpendicular distance from this intersection point to the center of the patella was measured as MAD.
Femoral anteversion (FA)
Time frame: From enrollment to the end of measurements at 3 weeks
On the axial images of the hip/pelvis covering the femoral head and neck, a line is drawn between the center of the femoral head and center of the femoral neck to calculate the uncorrected femoral anteversion angle. To correct for distal femoral rotation, another line is drawn along the posterior border of the femoral condyles to calculate the angle. Positive degrees between the femoral neck and the distal femoral axis are called femoral antetorsion; negative values were considered as femoral retrotorsion.
Medial proximal tibial angle (MPTA)
Time frame: From enrollment to the end of measurements at 3 weeks
The MPTA was defined as the medial angle between the proxsimal tibial joint line and the mechanical axis of the tibia. The proximal joint orientation line of tibia was drawn. A line was also drawn from the midpoint of the ankle to the midpoint of the knee on the tibial joint line. The angle between these two lines was measured.
Tibial torsion (TT)
Time frame: From enrollment to the end of measurements at 3 weeks
Proximal tibial axis (PTA) was placed along the posterior cortex of the tibial head at the level of condyls proximal to the fibular head. Distal tibial axis (DTA) was placed to the articular aspects of the medial and the lateral malleolus below the talar surface. The tibial torsion was calculated as the angle between the PTA and the DTA.
Tibial tubercle-trochlear groove (TT-TG) distance
Time frame: From enrollment to the end of measurements at 3 weeks
Firstly, transverse image that depicted a complete cartilaginous trochlea was used to determine the deepest point within the trochlear groove. A line was drawn through the deepest point of the trochlear groove, perpendicular to the posterior condylar tangent. Another line was drawn in parallel to the trochlear line through the most anterior portion of the tibial tubercle. Tibial tuberosity-trochlear groove distance was measured as the distance between these 2 lines.
Tibial tubercle-posterior cruciate ligament (TT-PCL)
Time frame: From enrollment to the end of measurements at 3 weeks
The TT-PCL distance was measured on axial images between the patellar tendon insertion midpoint and the medial border of the posterior cruciate ligament at its tibial insertion, parallel to the dorsal tibia condylar line.
Joint line convergence angle (JLCA)
Time frame: From enrollment to the end of measurements at 3 weeks
The mechanical axis line of femur was drawn, and then the knee joint line in the frontal plane was determined. The angle between these two lines was measured.
Hip-knee-ankle angle (HKA)
Time frame: From enrollment to the end of measurements at 3 weeks
The measurement was taken of the angle formed between the mechanical axis of the femur and tibia.
Mechanical lateral distal femoral angle (mLDFA)
Time frame: From enrollment to the end of measurements at 3 weeks
The distal joint orientation line of femur was drawn. A second line was drawn from the center of hip to the knee\'s midpoint at the femoral knee joint line (femoral mechanical axis). The angle between these two lines was measured.
Quadriceps femoris angle (Q angle)
Time frame: From enrollment to the end of measurements at 3 weeks
The angle between the lines connecting the anterior superior iliac spine (ASIS) to the midpoint of the patella, and from there to the tibial tubercle was measured.
1 secondary outcome
Isokinetic strength
Time frame: From enrollment to the end of measurements at 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Background: PubMed 26290852Asadi K, Mirbolook A, Heidarzadeh A, Mardani Kivi M, Emami Meybodi MK, Rouhi Rad M. Association of Soccer and Genu Varum in Adolescents. Trauma Mon. 2015 May;20(2):e17184. doi: 10.5812/traumamon.17184. Epub 2015 May 25.
- Derived from this study: PubMed 40001230Isin A, Kose O, Ak E, Emir Yetim E, Cevikol C, Melekoglu T. The influence of the lower limb components on genu varum in football players: a full leg length magnetic resonance imaging study. BMC Sports Sci Med Rehabil. 2025 Feb 25;17(1):25. doi: 10.1186/s13102-025-01075-9.
- Individual participant dataSharing planned: Yes. The datasets generated during the current study will be available upon request from corresponder author Tuba Melekoğlu
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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.
Tuba Melekoglu, Phd principal investigator
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genu Varum and Football Players, run by Tuba Melekoğlu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. 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: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mechanical axis deviation (MAD) (time frame: From enrollment to the end of measurements at 3 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06606964, which also lists 2 linked publications.
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 23 Sep 2024.