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NCT Number: NCT07400705

Short-term Outcomes of High Tibial Osteotomy Using a Plate Versus a Plate With an Interbody Fusion Cage in Adolescent Tibia Vara : a Comparative Study

Tibia vara is a progressive angular deformity of the lower limb centered at the proximal tibial physis, producing a characteristic bowing of the leg. The condition is believed to result from an abnormal distribution of biomechanical stresses combined with an underlying genetic predisposition. (1) Excessive mechanical loading on the medial portion of the proximal tibial growth plate leads to asymmetric physeal activity, ultimately causing a pathologic varus deformity of the tibia.(²)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag Univesity Hospitals

Sohag, Egypt

About this study

The adolescent tibia vara may affect one or both limbs and is typically identified during or shortly before the pubertal growth spurt. (1) It is more frequently reported among individuals of African descent and those with a body mass index (BMI) greater than 40. (2) The increased body weight in these patients accentuates compressive forces on the posteromedial aspect of the proximal tibial physis,(3) resulting in localized inhibition of growth according to the Heuter-Volkmann principle, and leading to progressive varus deformity.(4) In many cases, associated deformities may also be observed at the distal tibia or femur, presenting as either varus or valgus alignment abnormalities.(5) Given the mechanical and structural nature of this deformity, corrective high tibial osteotomy (HTO) remains the cornerstone of surgical management in adolescent tibia vara. Modern fixation methods particularly the use of plate fixation versus plate combined with interbody fusion cage are being explored to enhance alignment correction, stability, and long-term outcomes in this challenging age group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adolescents aged [10-18] years diagnosed with tibia vara.
  • Symptomatic varus deformity centered at the proximal tibia requiring surgical correction.
  • Both sexes included
  • Open or transitional growth plates are suitable for HTO.

Exclusion criteria

  • Prior tibial realignment surgery on the same side.
  • Ages below 10 years or above 18 years
  • Active infection, progressive metabolic disorder (e.g., rickets) or skeletal dysplasia, neuromuscular disorder, or systemic inflammatory arthritis.
  • Complex deformities need external fixation as the first-line treatment.
  • Patients with chronic comorbidities.
  • Associated with fractures in the same limb

Treatment and study plan

high tibial osteotomy using interbody fusion cage

Procedure

correction of adolescent tibia vara with high tibial osteotomy using interbody fusion cage

Primary outcomes

  1. correction of tibia vara radiologically

    Time frame: 6 months

    Change in MPTA from baseline to 6 months, measured on radiographs by two blinded observers.

  2. correction of tibia vara on radiographs

    Time frame: 6 months

    Change in MPTA from baseline to 6 months, measured on radiographs by two blinded observers.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.