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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMuhammed Cagatay Engin

About this trial

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.

Eligibility criteria

Qualifiers

Varus malalignment associated with medial compartment degeneration/osteoarthritis.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Medial HTO Locking Plate
  • Self-Adjusting HTO External Fixator

Treatment groups

28 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Muhammed Cagatay Engin

Lead sponsor

Ataturk University

Sponsor institution