Clinical trial NCT05128864: High Tibial Osteotomy With/Without Fulkerson Osteotomy in Knee OA
Official title: Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes of Hight Tibial Osteotomy With or Without Concomitant Fulkerson Osteotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Patellofemoral Disorder
Keywords: HTO
Fulkerson
Osteoarthritis
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Biomechanics MRI
timeFrame: 1 year
measure: Biomechanics MRI
timeFrame: 2 years
measure: Biomechanics X-ray
timeFrame: 12 weeks
measure: Biomechanics X-ray
timeFrame: 6 months
measure: Biomechanics X-ray
timeFrame: 12 months
measure: Biomechanics X-ray
timeFrame: 24 months
Secondary outcomes:
measure: KOOS
timeFrame: 12 weeks
measure: KOOS
timeFrame: 6 months
measure: KOOS
timeFrame: 12 months
measure: KOOS
timeFrame: 24 months
measure: IKDC
timeFrame: 12 weeks
measure: IKDC
timeFrame: 6 months
measure: IKDC
timeFrame: 12 months,
measure: IKDC
timeFrame: 24 months
measure: Tegner Lysholm
timeFrame: 12 weeks,
measure: Tegner Lysholm
timeFrame: 6 months
measure: Tegner Lysholm
timeFrame: 12 months
measure: Tegner Lysholm
timeFrame: 24 months
measure: SF-36
timeFrame: 12 weeks
measure: SF-36
timeFrame: 6 months
measure: SF-36
timeFrame: 12 months
measure: SF-36
timeFrame: 24 months
measure: VAS
timeFrame: 12 week
measure: VAS
timeFrame: 6 months
measure: VAS
timeFrame: 12 months
measure: VAS
timeFrame: 24 months
measure: Blood test
timeFrame: 2nd day
measure: Blood test
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Otwock
country: Poland
facility: Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital
state: Mazowieckie
Study officials:
affiliation: PCME, Otwock, Poland
name: Rafal Kaminski
role: PRINCIPAL_INVESTIGATOR
References: