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

MI-összefoglaló

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The trial is looking for adults with bow legs (varus) and wear of the inner part of the knee who need a knee bone-cutting surgery (medial opening wedge HTO). It compares a plate with an external frame.

Életkor

18 years or older

Nem

All sexes

A betegség stádiuma

Varus malalignment with medial compartment degeneration or osteoarthritis, with a reason for medial opening wedge HTO. Not advanced-stage osteoarthritis.

Korábbi kezelés

No previous open knee surgery on the same leg.

A részvétel fő kizáró okai

• Advanced-stage osteoarthritis that calls for a total knee replacement
• Previous open knee surgery on the same leg
• Unable to come to follow-up visits
• Serious other illnesses, such as uncontrolled diabetes or rheumatoid arthritis

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 2 csoportja

• Group 1: Plate FixationA vizsgált kezelés

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

  Kezelés: Medial HTO Locking Plate

• Group 2: HTO External FixatorMár használt kezelés, összehasonlításként

  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.

  Kezelés: Self-Adjusting HTO External Fixator