NCT07718438

Brief 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). 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). 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.

Trial Health

65
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Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
16mo left

Started Jun 2026

Status
not yet recruiting

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 Progress11%
Jun 2026Dec 2027

First Submitted

Initial submission to the registry

May 5, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

May 5, 2026

Last Update Submit

July 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • radiographic alignment parameters

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

    3 months postoperative

Study Arms (2)

Group A

single-leg stance group

Group B

double-leg stance group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with genu varum

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Genu Varum

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
residant doctor at Assiut university hospital

Study Record Dates

First Submitted

May 5, 2026

First Posted

July 22, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

July 22, 2026

Record last verified: 2026-07