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

NCT07212777 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-03

No results posted yet for this study

Summary

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.

Conditions

  • Arthritis (Knee)
  • Varus Knee

Interventions

PROCEDURE

Medial Open Wedge Hight Tibial Osteotomy using patient-specific instrumentation

Medial Open Wedge Hight Tibial Osteotomy using 3D printed patient-specific instrumentation as a guide for the osteotomy

PROCEDURE

Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques

Conventional Medial Open Wedge Hight Tibial Osteotomy

Sponsors & Collaborators

  • Hospital Universitario Virgen de la Victoria

    collaborator OTHER

  • University of Malaga

    lead OTHER

Principal Investigators

  • Antonio I Cuesta-Vargas, Prof., PhD · Universidad de Málaga

  • Juan Miguel Gómez-Palomo, PhD · Hospital Universitario Virgen de la Victoria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-15
Primary Completion
2027-09-30
Completion
2028-10-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07212777 on ClinicalTrials.gov