Patient-specific 3D-printed guide versus conventional open-wedge high tibial osteotomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Universitario Virgen de la Victoria de Málaga
  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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.