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

NCT07212777 · tracked via the Priya Life Science Spain tracker

Sponsor

University of Malaga

Phase

Not applicable

Started

2025-11-15

Last updated

2026-07-22

Condition(s) studied

Arthritis (Knee)Varus Knee

Investigational drug(s) / intervention(s)

Medial Open Wedge Hight Tibial Osteotomy using patient-specific instrumentationMedial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques

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

Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques: Conventional Medial Open Wedge Hight Tibial Osteotomy

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: * 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. Exclusion criteria: * Comorbidity/clinical situations: * Inflammatory arthritis (e.g., RA, spondyloarthropathies), unresolved previous joint infection or osteomyelitis. * Severe peripheral vasculopathy (ABI \<0.7), advanced peripheral neuropathy or Charcot foot. * Poorly controlled diabetes (HbA1c \>8.5%), advanced renal/hepatic failure (eGFR \<30 ml/min/1.73 m²; Child-Pugh B/C). * Smoking \>20 cigarettes/day without commitment to cessation; active IV drug use or uncontrolled alcoholism. * BMI \>35 kg/m². * Disorder affecting gait (e.g., neurological disease). * Inability to walk at a speed of at least 0.8m/s * Anatomy/radiology * Multiplanar deformities not correctable with isolated medial opening tibial valgus osteotomy (e.g., dominant femoral deformity). * Severe medial subchondral bone defect or extensive necrosis. * Sequelae of proximal tibia fracture or previous ipsilateral HTO that prevent correction or guide use. * Treatments/medication and logistics * Anticoagulation/antiplatelet therapy that cannot be suspended or bridged. * Systemic corticosteroids \>10 mg/day or high-risk immunosuppressants without possibility of adjustment. * Intra-articular infiltration (HA/CS/PRP) within the previous 60 days (respect defined wash-out). * Pregnancy. * Participation in another interfering trial. * Inability to undergo CT (e.g., uncontrollable claustrophobia). * Inability to complete ≥12 months of follow-up.

Primary outcome measure(s)

Angular precision in AP and lateral planes — Immediate postoperative period
Difference between planned and executed angles in AP and lateral planes
Distance to joint line — Immediate postoperative period
Difference between planned and executed distance between osteotomy cut and and joint line

Trial sites (1)

Facility	City	Region	Status
Hospital Universitario Virgen de la Victoria de Málaga	Málaga	Málaga	Recruiting

More University of Malaga trials in Spain

Morphological and Mechanical Assessment in the Achilles Tendon After Radiofrequency Stimulation in Runners Starting soon

Efficacy of Hyaluronic Acid Cream in Preventing Foot Ulceration Risk in Patients With Type 2 Diabetes and Moderate-to-Severe Peripheral Neuropathy: A Randomized Clinical Trial. Enrolling by invitation

Slow Breathing and Resistance Exercise in Fibromyalgia Enrolling by invitation

Effectiveness of 5-week Digital Respiratory Practice in Children With Duchenne and Becker Muscular Dystrophies. Enrolling by invitation

Foot and Ankle Strengthening Program to Improve Physical Function in Menopausal Women (FAMEX) Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07212777 on ClinicalTrials.gov ↗ ← All trials in Spain