NCT07220434

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Muhammed Cagatay Engin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Medial HTO Locking Plate	Medial Opening Wedge High Tibial Osteotomy.
DEVICE	Self-Adjusting HTO External Fixator	Medial Opening Wedge High Tibial Osteotomy.

Timeline

• Start date: 2025-11-15
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-10-23
• Last updated: 2025-10-23

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated device study