Precision of Pacient-specific Instrumented Open Wedge High Tibial Osteotomy vs Conventional Techn… (NCT07212777) | Clinical Trial Compass
RecruitingNot Applicable
Precision of Pacient-specific Instrumented Open Wedge High Tibial Osteotomy vs Conventional Technicque
Spain50 participantsStarted 2025-11-15
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 n…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.