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

NCT07220434 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-10-23

No results posted yet for this study

Summary

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.

Conditions

  • Medial Compartment Osteoarthritis
  • Genu Varum
  • Varus Deformity
  • High Tibial Osteotomy

Interventions

DEVICE

Medial HTO Locking Plate

Medial Opening Wedge High Tibial Osteotomy.

DEVICE

Self-Adjusting HTO External Fixator

Medial Opening Wedge High Tibial Osteotomy.

Sponsors & Collaborators

  • Muhammed Cagatay Engin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-15
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07220434 on ClinicalTrials.gov