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NCT Number: NCT07220434

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

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.

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Key information

Conditions

Medial Compartment Osteoarthritis Bone Diseases Genu Varum High Tibial Osteotomy Musculoskeletal Diseases Varus Deformity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University, Department of Orthopedics and Traumatology

Erzurum, 25240, Turkey (Türkiye)

Location contact

Muhammed Çağatay ENGİN, Assoc. Prof.

CONTACT

[email protected]

+90 532 330 1949

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Medial HTO Locking Plate

Device

Medial Opening Wedge High Tibial Osteotomy.

Self-Adjusting HTO External Fixator

Device

Medial Opening Wedge High Tibial Osteotomy.

Primary outcomes

  1. Change in Radiological Correction (Hip-Knee-Ankle Angle - HKA)

    Time frame: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative.

    ssessment of the mechanical axis on full-length weight-bearing radiographs (Measured in degrees).

  2. Change in Functional Status (Oxford Knee Score - OKS)

    Time frame: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative.

    Patient-reported functional score assessing pain and knee function.

  3. Change in Pain Intensity (Visual Analogue Scale - VAS)

    Time frame: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative

    Patient-reported pain score from 0 (no pain) to 10 (intolerable pain).

Secondary outcomes

  1. Change in Femoro-Tibial Angle (FTA)

    Time frame: Baseline (Preoperative) and 12 Months Postoperative.

    Change in the anatomical axis measured in degrees.

  2. Change in Mechanical Axis Percentage (MA%)

    Time frame: Baseline (Preoperative) and 12 Months Postoperative.

    Change in the position of the weight-bearing line on the tibial plateau.

  3. Change in Posterior Tibial Slope (PTE)

    Time frame: Baseline (Preoperative) and 12 Months Postoperative.

    Change in the tibial slope measured in degrees.

  4. Change in Patellar Height (Insall-Salvati Index)

    Time frame: Baseline (Preoperative) and 12 Months Postoperative.

    Change in patellar height measured by the Insall-Salvati ratio.

  5. Incidence of Complications

    Time frame: Up to 12 months postoperative.

    Incidence of adverse events including pin tract infection (especially Group 2), superficial or deep infection, non-union/delayed union, lateral cortex fracture, hardware exposure, or knee stiffness.

Study contacts

Contact information is provided by the study sponsor or research team.

ali afşar, md

CONTACT

[email protected]

+905374927543

Sponsors and collaborators

Lead sponsor

Muhammed Cagatay Engin

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 23, 2025
Registry last updated
Oct 23, 2025

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.

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