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TO Plate Fixation vs. External Fixator Comparison (HTO Plate vs. ExFix Study)
Sponsor: Muhammed Cagatay Engin
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
Medial HTO Locking Plate
Medial Opening Wedge High Tibial Osteotomy.
Self-Adjusting HTO External Fixator
Medial Opening Wedge High Tibial Osteotomy.
Locations (1)
Ataturk University, Department of Orthopedics and Traumatology
Erzurum, Erzurum, Turkey (Türkiye)