Health TrialsbyHealthPanel

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

ConditionsArthritis (Knee)Varus Knee
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Medial Open Wedge Hight Tibial Osteotomy using patient-specific instrumentation

    Procedure/Surgery

    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

    Procedure/Surgery

    Conventional Medial Open Wedge Hight Tibial Osteotomy

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Conventional surgeryActive comparator 1 intervention
Group B: Patient-specific instrumentationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Angular precision in AP and lateral planes

Difference between planned and executed angles in AP and lateral planes

Time frame
Immediate postoperative period
2

Distance to joint line

Difference between planned and executed distance between osteotomy cut and and joint line

Time frame
Immediate postoperative period

Secondary outcomes

1

Postoperative alignment (HKA angle)

Difference between planned and achieved hip-knee-ankle angle

Time frame
Immediate postoperative period
2

Posterior tibial slope (PTS)

Difference between planned and achieved tibial slope

Time frame
Immediate postoperative period
3

Surgical time

Duration from skin incision to closure

Time frame
Day of surgery
4

Number of fluoroscopic images

Total intraoperative fluoroscopy shots

Time frame
Day of surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Malaga

Lead sponsor

Hospital Universitario Virgen de la Victoria

Collaborator

Source ClinicalTrials.gov
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