TO Plate Fixation vs. External Fixator Comparison (HTO Plate vs. ExFix Study) (NCT07220434) | Clinical Trial Compass
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.
1This trial is comparing two surgical approaches for high tibial osteotomy — a plate fixation and an external fixator — and it hasn't started recruiting yet, so how long might it be before I could even potentially join, and would waiting affect my knee condition?
2The study is measuring changes in the hip-knee-ankle angle on X-ray, which reflects how well the bone alignment is corrected — is my current degree of varus deformity severe enough that this kind of correction would be a realistic goal for me?
3Since this trial is comparing two different fixation methods for the same osteotomy procedure, can you walk me through what the practical differences would be for my daily life — for example, does having an external fixator outside the leg mean a longer or more difficult recovery than the plate?
4The trial is measuring pain and knee function using the Oxford Knee Score and a pain scale — based on where I am with those measures right now, do you think I'm at a stage where surgery like this makes sense, or is there a non-surgical path worth trying first?
5Because this trial is still in the planning stage and hasn't begun recruiting, is there a comparable or already-active study, or a standard surgical option, that might be worth considering in the meantime rather than waiting?
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
1
Change in Radiological Correction (Hip-Knee-Ankle Angle - HKA)