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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Informed consent: able to sign informed consent

• Clinical: predominantly medial pain/limitation refractory ≥3-6 months

• Mobility: flexion ≥90º and flexion contracture ≤10º Stability: varus/valgus and pivot-shift ≤ grade 1.

• Radiology:

‣ Medial gonarthrosis Ahlbäck I-III with preserved lateral compartment.

⁃ Patellofemoral Iwano 0-2 without disabling patellofemoral pain.

⁃ Varus alignment: HKA 4-10°.

⁃ Predominantly tibial deformity (decreased MPTA; LDFA close to normal) according to planning.

• Anatomy/technical feasibility: proximal tibial morphology suitable for medial opening osteotomy and PSI guide placement.

Locations
Other Locations
Spain
Hospital Universitario Virgen de la Victoria de Málaga
RECRUITING
Málaga
Contact Information
Primary
Amparo Zamora-Mogollo
amparo.zamora@uma.es
+34673662020
Backup
Juan Miguel Gómez Palomo, PhD
jmgomezpalomo@gmail.com
Time Frame
Start Date: 2025-11-15
Estimated Completion Date: 2028-10
Participants
Target number of participants: 50
Treatments
Active_comparator: Conventional surgery
Osteotomy using conventional technique
Experimental: Patient-specific instrumentation
Osteotomy using 3D-printed patient-specific instrumentation
Related Therapeutic Areas
Sponsors
Collaborators: Hospital Universitario Virgen de la Victoria
Leads: University of Malaga

This content was sourced from clinicaltrials.gov