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
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2020
CompletedFirst Submitted
Initial submission to the registry
July 18, 2020
CompletedFirst Posted
Study publicly available on registry
November 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2022
CompletedNovember 22, 2021
November 1, 2021
1.9 years
July 18, 2020
November 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Biomechanics MRI
Patellofemoral Joints Biomechanics improvement measured
1 year
Biomechanics MRI
Patellofemoral Joints Biomechanics improvement measured
2 years
Biomechanics X-ray
Patellofemoral Joints Biomechanics improvement measured
12 weeks
Biomechanics X-ray
Patellofemoral Joints Biomechanics improvement measured
6 months
Biomechanics X-ray
Patellofemoral Joints Biomechanics improvement measured
12 months
Biomechanics X-ray
Patellofemoral Joints Biomechanics improvement measured
24 months
Secondary Outcomes (22)
KOOS
12 weeks
KOOS
6 months
KOOS
12 months
KOOS
24 months
IKDC
12 weeks
- +17 more secondary outcomes
Study Arms (2)
HTO and Fulkerson
ACTIVE COMPARATORHigh Tibial Osteotomy with Antero-medialisation of Tibial Tubercle
HTO
SHAM COMPARATORDescending Hight Tibial Osteotomy
Interventions
Eligibility Criteria
You may qualify if:
- Knee medial compartment or patellofemoral osteoarthritis in medical interview and physical examination
- Confirmation of cartilage degeneration/damage and knee malalignment in radiological tests
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital
Otwock, Masovian Voivodeship, 05-400, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rafal Kaminski
PCME, Otwock, Poland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair of Division
Study Record Dates
First Submitted
July 18, 2020
First Posted
November 22, 2021
Study Start
July 15, 2020
Primary Completion
May 30, 2022
Study Completion
May 30, 2022
Last Updated
November 22, 2021
Record last verified: 2021-11