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

Key facts

Who runs it
Muhammed Cagatay Engin
Where
Erzurum, TürkiyeSee the site
Trial code
Status
Not yet recruiting
People taking part
28 people, planned
Started
15 Nov 2025
Expected to end
31 Dec 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Medial HTO Locking Plate
  • Self-Adjusting HTO External Fixator
Record updated
23 October 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

Where in Türkiye

  • Ataturk University, Department of Orthopedics and TraumatologyErzurum, TürkiyeContact: Muhammed Çağatay ENGİN, Assoc. Prof.No longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Group 1: Plate FixationTreatment being tested

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

    Treatment: Medial HTO Locking Plate

  • Group 2: HTO External FixatorExisting treatment, for comparison

    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: Self-Adjusting HTO External Fixator

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Medial Opening Wedge High Tibial Osteotomy: A Comparative Study of Plate Fixation and Self-Adjusting HTO External Fixator Techniques
Record updated
23 October 2025