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Genu VarumNCT07718438

Radiological Comparison Between Single-Leg and Double-Leg Stance in the Assessment of Genu Varum: Pre- and Postoperative Evaluation and Functional Outcomes

An observational study of Genu Varum, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Genu varum, commonly known as bow-legged deformity, is characterized by an outward angulation of the knee joint that disrupts normal lower limb alignment and weight distribution(1,2). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Genu Varum
How many people
70 participants
Where
No sites listed yet
Study dates
Jun 2026to Dec 2027
Phase
Observational
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with genu varum

Who may be able to join

  • • Patients aged 18-65 years diagnosed with genu varum requiring surgical correction (e.g., high tibial osteotomy )
  • Willingness to participate and provide informed consent.
  • Ability to stand independently for radiographic assessment.
  • No prior lower limb surgery within the last year.

Who cannot join

  • Patients with genu varum with Blount's disease, rickets and metabolic bone disease.
  • History of knee surgery within the last year.
  • Neurological, psychological, or systemic disorders affecting gait or stance.
  • Inadequate preoperative or follow-up radiographs.
  • Inability to comply with follow-up schedule.

About this study

Genu varum, commonly known as bow-legged deformity, is characterized by an outward angulation of the knee joint that disrupts normal lower limb alignment and weight distribution(1,2). This condition alters the mechanical axis of the limb, often increasing medial compartment loading, which can accelerate degenerative joint changes and pain. Radiographic assessment plays a central role in quantifying the deformity, typically measured through parameters such as the hip-knee-ankle (HKA) angle, mechanical axis deviation (MAD), and medial proximal tibial angle (MPTA)(1,2).

Weight-bearing posture during imaging significantly influences these alignment parameters. Several studies have demonstrated that single-leg stance radiographs produce more physiologically representative alignment measurements than double-leg stance, since the single-leg condition better simulates natural load distribution and joint reaction forces during locomotion(3,4). The single-leg stance increases joint compression and reveals hidden malalignments that may be masked in double-leg or non-weight-bearing positions. Consequently, preoperative evaluations based solely on double-leg stance may underestimate the severity of genu varum deformity(3,4).

Read more

Surgical correction, through techniques such as high tibial osteotomy or guided growth, aims to restore the mechanical axis to a near-neutral position, improving load symmetry and delaying degenerative changes(4,5). Postoperative evaluation is essential for monitoring realignment success and predicting functional recovery, which often involves comparing radiological correction with clinical outcomes such as range of motion, pain reduction, and activity resumption. However, the correspondence between radiographic correction measured under different stance conditions and postoperative function remains poorly defined(6,7).

Recent evidence suggests that patients assessed preoperatively under single-leg stance conditions may have more accurate predictions of postoperative alignment and function than those evaluated under double-leg stance (5,6). Furthermore, differences between stance types may influence surgical planning decisions, including the degree of correction targeted and the fixation technique used. Functional outcomes after genu varum correction depend not only on bony realignment but also on balanced muscular forces, proprioception, and joint stability - factors more dynamically engaged in single-leg stance evaluation(7,8).

Despite increasing recognition of weight-bearing differences in radiological evaluation, limited research directly compares single-leg versus double-leg stance assessment for genu varum across preoperative and postoperative stages. Establishing which stance provides a more reliable correlation with functional outcomes could refine surgical planning, enhance rehabilitation monitoring, and standardize postoperative evaluation protocols for improved patient outcomes.

Conditions
Genu Varum
Medical subject headings
Genu Varum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07718438
Study groupRoleWhat they receive
Group Asingle-leg stance group
Group Bdouble-leg stance group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. radiographic alignment parameters

    Difference in radiographic alignment parameters between single-leg and double-leg stance pre- and postoperatively.

    Measured: 3 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07718438
Sponsor's protocol ID
RadiologicalSingle Double leg
Status last verified
Jul 2026
First submitted
5 May 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Genu Varum, run by Assiut University.

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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

radiographic alignment parameters (time frame: 3 months postoperative). 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 22 Jul 2026.

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