Patient-specific 3D-printed guide versus conventional open-wedge high tibial osteotomy
Precisión de la osteotomía Tibial Proximal Con Instrumental Paciente-específico vs técnica Convencional
This trial will test whether using patient-specific 3D-printed surgical guides makes the bone cut more accurate than the conventional technique for adults with medial knee osteoarthritis and varus deformity who are candidates for medial opening wedge high tibial osteotomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Malaga Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Málaga) |
| Trial ID | NCT07212777 on ClinicalTrials.gov |
What this trial studies
This single-center randomized trial will enroll 50 adult patients with medial knee osteoarthritis and varus alignment who are planned for medial opening wedge high tibial osteotomy, randomly assigning them to conventional technique or patient-specific instrumentation (PSI) created from preoperative CT. The primary outcome is osteotomy accuracy, measured by comparing preoperative 3D planning with postoperative CT scans. Secondary outcomes include leg alignment, surgical time, radiation exposure, complications, functional recovery using KOOS/WOMAC/IKDC/EQ-5D, and gait analysis with depth cameras, with follow-up to 12 months. The trial compares operative workflow and reproducibility of correction between PSI-guided and conventional fluoroscopy/anatomic landmark techniques.
Who should consider this trial
Good fit: Adults with predominantly medial knee pain from Ahlbäck I–III medial gonarthrosis, varus alignment (HKA 4–10°) with mainly tibial deformity, adequate knee range of motion, and anatomy suitable for a medial opening-wedge osteotomy and PSI guide placement are eligible.
Not a fit: Patients with inflammatory arthritis, unresolved joint infection, severe vascular or neuropathic disease, poorly controlled diabetes, unsuitable proximal tibial anatomy, or significant lateral compartment or patellofemoral disease are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, PSI could improve the precision of the bone cut and alignment, potentially reducing residual deformity, complications, radiation exposure, and improving function.
How similar studies have performed: Smaller observational and design-based studies of PSI for high tibial osteotomy have reported improved cut accuracy and reproducibility, but randomized data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Málaga
- Hospital Universitario Virgen de la Victoria de Málaga — Málaga, Spain (Recruiting)
Study contacts
- Principal investigator: Antonio I Cuesta-Vargas, Prof., PhD — Universidad de Málaga
- Study coordinator: Amparo Zamora-Mogollo
- Email: amparo.zamora@uma.es
- Phone: +34673662020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.