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Not yet recruiting NCT07220434

TO Plate Fixation vs. External Fixator Comparison (HTO Plate vs. ExFix Study)

No phase Interventional Medial Compartment Osteoarthritis Genu Varum Varus Deformity High Tibial Osteotomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medial HTO Locking Plate, Self-Adjusting HTO External Fixator.
Who it may be relevant to
Registry conditions: Medial Compartment Osteoarthritis, Genu Varum, Varus Deformity, High Tibial Osteotomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Medial Opening Wedge High Tibial Osteotomy: A Comparative Study of Plate Fixation and Self-Adjusting HTO External Fixator Techniques

Overview

This study aims to compare the efficacy, accuracy, and functional outcomes of two different surgical stabilization techniques for medial opening wedge high tibial osteotomy (HTO) in patients with varus deformity and medial compartment osteoarthritis. Patients will be prospectively randomized into two groups: Group 1 (Plate Fixation) will receive acute (single-stage) correction and stabilization with a medial HTO locking plate. Group 2 (HTO External Fixator) will receive stabilization using a self-adjusting HTO external fixator, followed by gradual correction (hemicallotasis/distraction) starting 7 days post-operatively. The study will evaluate radiological correction, functional improvement (using the Oxford Knee Score), and complication rates over a 12-month follow-up period.

Interventions

  • Device Medial HTO Locking Plate
    Medial Opening Wedge High Tibial Osteotomy.
  • Device Self-Adjusting HTO External Fixator
    Medial Opening Wedge High Tibial Osteotomy.

Primary outcome measures

  • Change in Radiological Correction (Hip-Knee-Ankle Angle - HKA) [Time frame: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative.]
  • Change in Functional Status (Oxford Knee Score - OKS) [Time frame: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative.]
  • Change in Pain Intensity (Visual Analogue Scale - VAS) [Time frame: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative]
Secondary outcome measures (5)
  • Change in Femoro-Tibial Angle (FTA) [Time frame: Baseline (Preoperative) and 12 Months Postoperative.]
  • Change in Mechanical Axis Percentage (MA%) [Time frame: Baseline (Preoperative) and 12 Months Postoperative.]
  • Change in Posterior Tibial Slope (PTE) [Time frame: Baseline (Preoperative) and 12 Months Postoperative.]
  • Change in Patellar Height (Insall-Salvati Index) [Time frame: Baseline (Preoperative) and 12 Months Postoperative.]
  • Incidence of Complications [Time frame: Up to 12 months postoperative.]

Eligibility criteria

Inclusion criteria

  • Varus malalignment associated with medial compartment degeneration/osteoarthritis.

Indication for Medial Opening Wedge HTO. Aged 18 years or older. Willing to participate in the study and provide written informed consent.

Exclusion criteria

  • Advanced-stage osteoarthritis (Indication for Total Knee Arthroplasty). Previous open knee surgery on the same extremity. Inability to comply with follow-up appointments. Significant comorbidities (e.g., uncontrolled diabetes, rheumatoid arthritis).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Ataturk University, Department of Orthopedics and Traumatology — Erzurum

Identifiers

NCT: NCT07220434 · HTOexfix1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗