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NOT YET RECRUITING
NCT07220434
NA

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

Sponsor: Muhammed Cagatay Engin

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2025-11-15

Completion Date

2028-12-31

Last Updated

2025-10-23

Healthy Volunteers

No

Interventions

DEVICE

Medial HTO Locking Plate

Medial Opening Wedge High Tibial Osteotomy.

DEVICE

Self-Adjusting HTO External Fixator

Medial Opening Wedge High Tibial Osteotomy.

Locations (1)

Ataturk University, Department of Orthopedics and Traumatology

Erzurum, Erzurum, Turkey (Türkiye)