Status:
RECRUITING
Precision of Pacient-specific Instrumented Open Wedge High Tibial Osteotomy vs Conventional Technicque
Lead Sponsor:
University of Malaga
Collaborating Sponsors:
Hospital Universitario Virgen de la Victoria
Conditions:
Arthritis (Knee)
Varus Knee
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 os...
Detailed Description
Medial opening wedge high tibial osteotomy is a well-established surgical procedure to correct knee alignment in patients with medial knee osteoarthritis and varus deformity. The accuracy of the bone ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07212777
Start Date
November 15 2025
End Date
October 1 2028
Last Update
November 17 2025
Active Locations (1)
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1
Hospital Universitario Virgen de la Victoria de Málaga
Málaga, Málaga, Spain, 29010