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)

Study Overview

• Status: Active, not recruiting
• Conditions: Tibia Vara in Children
• Intervention / Treatment: Procedure: high tibial osteotomy using interbody fusion cage

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag Univesity Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: Corrective HTO with plate fixation only.	Procedure: high tibial osteotomy using interbody fusion cage; correction of adolescent tibia vara with high tibial osteotomy using interbody fusion cage
Active Comparator: Group B: Corrective HTO with plate fixation plus an interbody fusion cage.	Procedure: high tibial osteotomy using interbody fusion cage; correction of adolescent tibia vara with high tibial osteotomy using interbody fusion cage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correction of tibia vara radiologically	Change in MPTA from baseline to 6 months, measured on radiographs by two blinded observers.	6 months
correction of tibia vara on radiographs	Change in MPTA from baseline to 6 months, measured on radiographs by two blinded observers.	6 months

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Jang SH, Chang CH, Jung YJ, Kwon HG. Hypersomnia due to injury of the ventral ascending reticular activating system following cerebellar herniation: A case report. Medicine (Baltimore). 2017 Jan;96(1):e5678. doi: 10.1097/MD.0000000000005678.

Helpful Links

• Anteromedial incision , osteotomy cut and open using laminar spreader then insert suitable size cage and apply plate

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2025
• Primary Completion (Actual): October 6, 2025
• Study Completion (Estimated): October 6, 2026

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Tibia vara is a progressive angular deformity of the lower limb centered at the proximal tibial physis, producing a characteristic bowing of the leg.
• Other Study ID Numbers: Soh-Med-26-1-3MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data and related study documents (protocol, CRF, SAP) will be made available upon reasonable request. Data will be accessible starting 6 months after the main results publication and will remain available for at least 5 years. Access will be granted to qualified researchers after approval of a research proposal and completion of a data sharing agreement. Data will be stored in a secure, publicly accessible repository
• IPD Sharing Time Frame: 6 months anf for 5 years
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No