An interventional study of Medial HTO Locking Plate and Self-Adjusting HTO External Fixator in Medial Compartment Osteoarthritis, Genu Varum and Varus Deformity, sponsored by Muhammed Cagatay Engin. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-23.
Sponsored by Muhammed Cagatay Engin · Not applicable, Interventional, and Treatment
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.
18 studies on the registry are indexed under Genu Varum; 8 are open to participants now.
This study's planned enrollment of 28 is below the median of 60 across 12 interventional studies indexed under Genu Varum.
Browse Genu Varum studies →This is the only study on the registry with Muhammed Cagatay Engin as lead sponsor.
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Indication for Medial Opening Wedge HTO. Aged 18 years or older. Willing to participate in the study and provide written .
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The osteotomy will be acutely corrected intraoperatively and stabilized using a Medial High Tibial locking plate.
Device: Medial HTO Locking Plate
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.
Device: Self-Adjusting HTO External Fixator
Medial Opening Wedge High Tibial Osteotomy.
Medial Opening Wedge High Tibial Osteotomy.
Change in Radiological Correction (Hip-Knee-Ankle Angle - HKA)
ssessment of the mechanical axis on full-length weight-bearing radiographs (Measured in degrees).
Time frame: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative.
Change in Functional Status (Oxford Knee Score - OKS)
Patient-reported functional score assessing pain and knee function.
Time frame: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative.
Change in Pain Intensity (Visual Analogue Scale - VAS)
Patient-reported pain score from 0 (no pain) to 10 (intolerable pain).
Time frame: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative
Change in Femoro-Tibial Angle (FTA)
Change in the anatomical axis measured in degrees.
Time frame: Baseline (Preoperative) and 12 Months Postoperative.
Change in Mechanical Axis Percentage (MA%)
Change in the position of the weight-bearing line on the tibial plateau.
Time frame: Baseline (Preoperative) and 12 Months Postoperative.
Change in Posterior Tibial Slope (PTE)
Change in the tibial slope measured in degrees.
Time frame: Baseline (Preoperative) and 12 Months Postoperative.
Change in Patellar Height (Insall-Salvati Index)
Change in patellar height measured by the Insall-Salvati ratio.
Time frame: Baseline (Preoperative) and 12 Months Postoperative.
Incidence of Complications
Incidence of adverse events including pin tract infection (especially Group 2), superficial or deep infection, non-union/delayed union, lateral cortex fracture, hardware exposure, or knee stiffness.
Time frame: Up to 12 months postoperative.
Start is estimated for Nov 2025; primary completion for Dec 2028, 37 months later.
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This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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