NCT07212777

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

Precisión de la osteotomía Tibial Proximal Con Instrumental Paciente-específico vs técnica Convencional

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Malaga · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Medial opening wedge high tibial osteotomy is a well-established surgical procedure to correct knee alignment in patients with medial knee osteoarthritis and varus deformity. The accuracy of the bone cut is critical for surgical success. However, conventional techniques performed with anatomical landmarks and fluoroscopy may result in variability and suboptimal correction. Recent advances in 3D imaging and printing allow the creation of patient-specific surgical guides designed from preoperative CT scans. These guides may improve the accuracy and reproducibility of the osteotomy. This single-center randomized clinical trial will include 50 adult patients, randomly assigned to undergo conventional osteotomy or osteotomy assisted by patient-specific instrumentation. The main outcome is the accuracy of the osteotomy cut compared with preoperative planning. Secondary outcomes include leg alignment, surgical efficiency, radiation exposure, complications, and functional recovery. Patients will be followed for 12 months.

Conditions

• Arthritis (Knee)
• Varus Knee

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-15
• Primary completion: 2027-09-01
• Completion: 2028-10-01
• First posted: 2025-10-08
• Last updated: 2026-04-03

Locations

1 site across 1 country: Spain