Not Yet RecruitingNot Applicable

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

Turkey (Türkiye)28 participantsStarted 2025-11-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Radiological Correction (Hip-Knee-Ankle Angle - HKA)

Timeframe: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative.

Change in Functional Status (Oxford Knee Score - OKS)

Timeframe: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative.

Change in Pain Intensity (Visual Analogue Scale - VAS)

Timeframe: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative

Trial details

NCT IDNCT07220434

SponsorMuhammed Cagatay Engin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

ali afşar, md

+905374927543 afsarali1708@gmail.com

View on ClinicalTrials.gov More Medial Compartment Osteoarthritis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Radiological Correction (Hip-Knee-Ankle Angle - HKA)

Timeframe: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative.

Change in Functional Status (Oxford Knee Score - OKS)

Timeframe: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative.

Change in Pain Intensity (Visual Analogue Scale - VAS)

Timeframe: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative