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Precision of Pacient-specific Instrumented Open Wedge High Tibial Osteotomy vs Conventional Technicque

Study acronym: AMBE_OR
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Secondary endpoints revised (22)
    • Site details revised
    v4
  2. Minor Site details revisedv3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 15, 2025 to Nov 15, 2025
    • Site details revised
    • Publications: details revised at 11 of 11 entries
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is a randomized clinical trial that will compare two surgical techniques for patients with knee osteoarthritis and varus deformity who are candidates for medial opening wedge high tibial osteotomy. The goal is to evaluate whether using patient-specific 3D-printed surgical guides improves the accuracy of the bone cut compared with the conventional technique performed with anatomical landmarks and fluoroscopy. A total of 50 adult patients will be randomly assigned to one of two groups: conventional osteotomy or osteotomy assisted by patient-specific instrumentation (PSI). The main outcome is the accuracy of the osteotomy cut, measured by comparing preoperative planning with the postoperative CT scan. Secondary outcomes include leg alignment, surgical time, radiation exposure, complications, and functional recovery assessed with validated questionnaires (KOOS, WOMAC, IKDC, EQ-5D) and gait analysis using depth cameras. Patients will be followed for up to 12 months after surgery to evaluate clinical and radiological outcomes.
Trial Details
NCT Number NCT07212777
Lead Sponsor University of Malaga
Collaborators: Hospital Universitario Virgen de la Victoria
Conditions
(from sponsor)
Arthritis (Knee), Varus Knee
Related terms Arthritis
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov