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High Tibial Osteotomy With/Without Fulkerson Osteotomy in Knee OA

Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes of Hight Tibial Osteotomy With or Without Concomitant Fulkerson Osteotomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05128864
Enrollment
110
Registered
2021-11-22
Start date
2020-07-15
Completion date
2022-05-30
Last updated
2021-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee, Patellofemoral Disorder

Keywords

HTO, Fulkerson, Osteoarthritis

Brief summary

This study will compare Hight Tibial Osteotomy with or without Fulkerson Osteotomy performed on patients with early stages of Osteoarthritis with patellofemoral joint disorders. The purpose of this study is evaluate which type of osteotomy provides better clinical, radiological and laboratory outcomes.

Detailed description

Progression of knee cartilage degenerative changes leads to necessary total knee arthroplasty in future, which is the most popular procedure for treating OA. HTO applied at early stages of osteoarthritis allow slow down cartilage degeneration process, but the choice of performed surgery depends on surgeons personal assessment. Patellofemoral Pain Syndrome often occurs with knee arthritis. Antero-medialisation of tibial tubercle is frequent procedures for patella maltracking. So far, both, HTO and Fulkerson osteotomy was performed separately, even if patient have symptoms from patellofemoral joint and OA. The investigators believe that simultaneously surgery of HTO and fulkerson Osteotomy provides better outcomes and significantly slow down knee degeneration.

Interventions

Surgery procedure - High Tibial Osteotomy

Sponsors

Centre of Postgraduate Medical Education
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Knee medial compartment or patellofemoral osteoarthritis in medical interview and physical examination * Confirmation of cartilage degeneration/damage and knee malalignment in radiological tests

Exclusion criteria

* no informed consent to participate in the study * age under 18 years or above 65 * multi ligament injury or single plane knee instability * another musculoskeletal disorders in lower limb * lower limb deformity requiring axis correction below 4o or above 12.5o * joints inflammatory diseases * ASA score \> II

Design outcomes

Primary

MeasureTime frameDescription
Biomechanics MRI1 yearPatellofemoral Joints Biomechanics improvement measured
Biomechanics X-ray12 weeksPatellofemoral Joints Biomechanics improvement measured

Secondary

MeasureTime frameDescription
Tegner Lysholm12 weeks,Tegner Lysholm Knee Scoring Scale
SF-3612 weeksThe Short Form (36) Health Survey
KOOS12 weeksKnee Injury and Osteoarthritis Outcome Score
Blood test2nd dayCRP, IL-6, CTx
VAS12 weekPain Visual Analog Scale
IKDC12 weeksInternational Knee Documentation Committee

Countries

Poland

Contacts

Primary ContactRafał Kamiński, MD PhD
kaminski@spskgruca.pl+48227794031

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026