NCT06606964

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

1.1 years

First QC Date

September 16, 2024

Last Update Submit

September 18, 2024

Conditions

Keywords

Genu varumKnee jointMechanical axis deviationIsokinetic strengthFootball players

Outcome Measures

Primary Outcomes (10)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    From enrollment to the end of measurements at 3 weeks

Secondary Outcomes (1)

  • Isokinetic strength

    From enrollment to the end of measurements at 3 weeks

Study Arms (2)

Football players with genu varum

Football players with genu varum leg alignment

Diagnostic Test: Magnetic Resonance ImagingOther: Isokinetic Strength

Football players without genu varum

Football players with normal lower extremity alignment

Diagnostic Test: Magnetic Resonance ImagingOther: Isokinetic Strength

Interventions

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

Football players with genu varumFootball players without genu varum

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

Football players with genu varumFootball players without genu varum

Eligibility Criteria

Age16 Years - 19 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University Faculty of Sport Sciences

Antalya, Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 26290852BACKGROUND
  • Isin 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.

MeSH Terms

Conditions

Genu Varum

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Tuba Melekoglu, Phd

    Akdeniz University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

September 16, 2024

First Posted

September 23, 2024

Study Start

December 1, 2021

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

September 23, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

The datasets generated during the current study will be available upon request from corresponder author Tuba Melekoğlu

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
The datasets generated during the current study will be available upon request from publishing date
Access Criteria
The datasets generated during the current study will be available for researchers

Locations