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

NCT ID: NCT07220434

Last Updated: 2025-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-15

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Medial Compartment Osteoarthritis Genu Varum Varus Deformity High Tibial Osteotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1: Plate Fixation

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

Group Type EXPERIMENTAL

Medial HTO Locking Plate

Intervention Type DEVICE

Medial Opening Wedge High Tibial Osteotomy.

Group 2: HTO External Fixator

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.

Group Type ACTIVE_COMPARATOR

Self-Adjusting HTO External Fixator

Intervention Type DEVICE

Medial Opening Wedge High Tibial Osteotomy.

Interventions

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Medial HTO Locking Plate

Medial Opening Wedge High Tibial Osteotomy.

Intervention Type DEVICE

Self-Adjusting HTO External Fixator

Medial Opening Wedge High Tibial Osteotomy.

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muhammed Cagatay Engin

OTHER

Sponsor Role lead

Responsible Party

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Muhammed Cagatay Engin

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ataturk University, Department of Orthopedics and Traumatology

Erzurum, Erzurum, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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ali afşar, md

Role: CONTACT

+905374927543

Facility Contacts

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Muhammed Çağatay ENGİN, Assoc. Prof.

Role: primary

+90 532 330 1949

Other Identifiers

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HTOexfix1

Identifier Type: -

Identifier Source: org_study_id

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