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

Muhammed Cagatay Engin

Status: Not yet enrolling

Conditions: Genu Varum; Medial Compartment Osteoarthritis; High Tibial Osteotomy; Varus Deformity

Treatments: Device: Self-Adjusting HTO External Fixator; Device: Medial HTO Locking Plate

Study type: Interventional

Funder types: Other

Identifiers

NCT07220434

HTOexfix1

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Varus malalignment associated with medial compartment degeneration/osteoarthritis.

Indication for Medial Opening Wedge HTO. Aged 18 years or older. Willing to participate in the study and provide written informed consent.

Exclusion criteria

• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Group 1: Plate Fixation

Experimental group

Description:

The osteotomy will be acutely corrected intraoperatively and stabilized using a Medial High Tibial locking plate.

Treatment:

Device: Medial HTO Locking Plate

Group 2: HTO External Fixator

Active Comparator group

Description:

he osteotomy will be stabilized using a Self-Adjusting HTO External Fixator. Gradual distraction (hemicallotasis) will begin 7 days post-operatively at a rate of 1 mm per day to achieve correction.

Treatment:

Device: Self-Adjusting HTO External Fixator