Actively Recruiting
Precision of Pacient-specific Instrumented Open Wedge High Tibial Osteotomy vs Conventional Technicque
Led by University of Malaga · Updated on 2026-04-03
50
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
Sponsors
U
University of Malaga
Lead Sponsor
H
Hospital Universitario Virgen de la Victoria
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Precision of Pacient-specific Instrumented Open Wedge High Tibial Osteotomy vs Conventional Technicque
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed consent
- Predominantly medial knee pain or limitation lasting 3 to 6 months or more
- Knee mobility: flexion of 90 degrees or more and flexion contracture of 10 degrees or less
- Stability with varus/valgus and pivot-shift grades 1 or less
- Medial gonarthrosis Ahlb�e4ck stages I to III with preserved lateral knee compartment
- Patellofemoral Iwano stages 0 to 2 without disabling patellofemoral pain
- Varus alignment with hip-knee-ankle angle between 4 and 10 degrees
- Mainly tibial deformity suitable for planned surgery
- Proximal tibia shape suitable for medial opening osteotomy and patient-specific instrumentation guide placement
You will not qualify if you...
- Inflammatory arthritis such as rheumatoid arthritis or spondyloarthropathies
- Unresolved previous joint infection or osteomyelitis
- Severe peripheral vascular disease with ankle-brachial index less than 0.7
- Advanced peripheral neuropathy or Charcot foot
- Poorly controlled diabetes with HbA1c above 8.5%
- Advanced kidney or liver failure (eGFR below 30 ml/min/1.73 m2; Child-Pugh B or C)
- Smoking more than 20 cigarettes per day without plan to quit
- Active intravenous drug use or uncontrolled alcoholism
- Body mass index over 35 kg/m2
- Neurological disorder affecting walking ability
- Inability to walk at least 0.8 meters per second
- Multiplanar deformities not correctable with isolated medial tibial valgus osteotomy
- Severe medial subchondral bone defect or extensive necrosis
- Past proximal tibia fracture or previous same-side high tibial osteotomy preventing correction or guide use
- Anticoagulation or antiplatelet treatment that cannot be safely paused or bridged
- Use of systemic corticosteroids above 10 mg/day or high-risk immunosuppressants without possibility to adjust
- Intra-articular injections (like hyaluronic acid, corticosteroids, or platelet-rich plasma) within previous 60 days
- Pregnancy
- Participation in another interfering clinical trial
- Inability to undergo CT scan such as uncontrolled claustrophobia
- Inability to complete at least 12 months of follow-up
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitario Virgen de la Victoria de Málaga
Málaga, Spain, 29010
Actively Recruiting
Research Team
A
Amparo Zamora-Mogollo
CONTACT
J
Juan Miguel Gómez Palomo, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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