NCT07548749

Brief Summary

Coronal angular deformities of the lower limbs, such as bow legs and knock-knees, are frequently observed in childhood. While many cases are considered normal and resolve on their own, when these deformities become significant and progressive, they can disrupt the quality of life, leading to gait disturbances, pain, and in severe instances, joint instability. Additionally, these deformities may have indirect effects on other joints like the hip and ankle, and most importantly, they increase the risk of early osteoarthritis in the knee . It is generally accepted that a significant deformity that persists up to preadolescence will not correct spontaneously. Physiological alignment of the lower limb is crucial for the symmetrical distribution of weight over the surfaces of the joints, especially the knee. Indeed, severe coronal malalignment has been linked to knee pain, altered gait, and occasionally patellofemoral problems .

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started May 2026

Geographic Reach
1 country

1 active site

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 Progress2%
May 2026Apr 2027

First Submitted

Initial submission to the registry

April 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 15, 2026

Last Update Submit

April 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • correction of deformity

    6 months after surgery

Study Arms (2)

Go for transphyseal screws

ACTIVE COMPARATOR
Procedure: hemiepiphysiodesis

Go for eight plates

ACTIVE COMPARATOR
Procedure: hemiepiphysiodesis

Interventions

Hemiepiphysiodesis is a safe, effective, and minimally invasive method for correcting angular deformities in growing children. The two main techniques-transphyseal screw and eight-plate-both rely on guided growth principles but differ in mechanics, control, and risk profile. Careful patient selection, timing, and follow-up are key to achieving optimal results.

Go for eight platesGo for transphyseal screws

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Both gender (males and females)
  • Children ≥3 years old and growing children 2 years at least remaining in growth ( skeletal immature)
  • Cases with progressive knee deformities around knee at any side.

You may not qualify if:

  • \. Physeal closure.
  • \. Physiological deformity in younger ages that could be managed conservatively ( age \< 3 years )
  • \. Cases with metabolic or chronic illness conditions unresolved.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag faculty of medicine

Sohag, Egypt

Location

Central Study Contacts

Hossam Hosny omar Mansour

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hossam hosny omar mansour

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 23, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations