Precision of Pacient-specific Instrumented Open Wedge High Tibial Osteotomy vs Conventional Technicque
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Malaga
About this trial
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 criteria
Qualifiers
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.
Medial gonarthrosis Ahlbäck I-III with preserved lateral compartment.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Medial Open Wedge Hight Tibial Osteotomy using patient-specific instrumentation
- Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Malaga
Lead sponsor
Hospital Universitario Virgen de la Victoria
Collaborator
Source ClinicalTrials.gov