High Tibial Osteotomy With/Without Fulkerson Osteotomy in Knee OA
Primary Purpose
Osteoarthritis, Knee, Patellofemoral Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
High Tibial Osteotomy
Sponsored by
About this trial
This is an interventional health services research trial for Osteoarthritis, Knee focused on measuring HTO, Fulkerson, Osteoarthritis
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
Sites / Locations
- Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
HTO and Fulkerson
HTO
Arm Description
High Tibial Osteotomy with Antero-medialisation of Tibial Tubercle
Descending Hight Tibial Osteotomy
Outcomes
Primary Outcome Measures
Biomechanics MRI
Patellofemoral Joints Biomechanics improvement measured
Biomechanics MRI
Patellofemoral Joints Biomechanics improvement measured
Biomechanics X-ray
Patellofemoral Joints Biomechanics improvement measured
Biomechanics X-ray
Patellofemoral Joints Biomechanics improvement measured
Biomechanics X-ray
Patellofemoral Joints Biomechanics improvement measured
Biomechanics X-ray
Patellofemoral Joints Biomechanics improvement measured
Secondary Outcome Measures
KOOS
Knee Injury and Osteoarthritis Outcome Score
KOOS
Knee Injury and Osteoarthritis Outcome Score
KOOS
Knee Injury and Osteoarthritis Outcome Score
KOOS
Knee Injury and Osteoarthritis Outcome Score
IKDC
International Knee Documentation Committee
IKDC
International Knee Documentation Committee
IKDC
International Knee Documentation Committee
IKDC
International Knee Documentation Committee
Tegner Lysholm
Tegner Lysholm Knee Scoring Scale
Tegner Lysholm
Tegner Lysholm Knee Scoring Scale
Tegner Lysholm
Tegner Lysholm Knee Scoring Scale
Tegner Lysholm
Tegner Lysholm Knee Scoring Scale
SF-36
The Short Form (36) Health Survey
SF-36
The Short Form (36) Health Survey
SF-36
The Short Form (36) Health Survey
SF-36
The Short Form (36) Health Survey
VAS
Pain Visual Analog Scale
VAS
Pain Visual Analog Scale
VAS
Pain Visual Analog Scale
VAS
Pain Visual Analog Scale
Blood test
CRP, IL-6, CTx
Blood test
CRP, IL-6, CTx
Full Information
NCT ID
NCT05128864
First Posted
July 18, 2020
Last Updated
November 9, 2021
Sponsor
Centre of Postgraduate Medical Education
1. Study Identification
Unique Protocol Identification Number
NCT05128864
Brief Title
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
May 30, 2022 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre of Postgraduate Medical Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Patellofemoral Disorder
Keywords
HTO, Fulkerson, Osteoarthritis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HTO and Fulkerson
Arm Type
Active Comparator
Arm Description
High Tibial Osteotomy with Antero-medialisation of Tibial Tubercle
Arm Title
HTO
Arm Type
Sham Comparator
Arm Description
Descending Hight Tibial Osteotomy
Intervention Type
Procedure
Intervention Name(s)
High Tibial Osteotomy
Intervention Description
Surgery procedure - High Tibial Osteotomy
Primary Outcome Measure Information:
Title
Biomechanics MRI
Description
Patellofemoral Joints Biomechanics improvement measured
Time Frame
1 year
Title
Biomechanics MRI
Description
Patellofemoral Joints Biomechanics improvement measured
Time Frame
2 years
Title
Biomechanics X-ray
Description
Patellofemoral Joints Biomechanics improvement measured
Time Frame
12 weeks
Title
Biomechanics X-ray
Description
Patellofemoral Joints Biomechanics improvement measured
Time Frame
6 months
Title
Biomechanics X-ray
Description
Patellofemoral Joints Biomechanics improvement measured
Time Frame
12 months
Title
Biomechanics X-ray
Description
Patellofemoral Joints Biomechanics improvement measured
Time Frame
24 months
Secondary Outcome Measure Information:
Title
KOOS
Description
Knee Injury and Osteoarthritis Outcome Score
Time Frame
12 weeks
Title
KOOS
Description
Knee Injury and Osteoarthritis Outcome Score
Time Frame
6 months
Title
KOOS
Description
Knee Injury and Osteoarthritis Outcome Score
Time Frame
12 months
Title
KOOS
Description
Knee Injury and Osteoarthritis Outcome Score
Time Frame
24 months
Title
IKDC
Description
International Knee Documentation Committee
Time Frame
12 weeks
Title
IKDC
Description
International Knee Documentation Committee
Time Frame
6 months
Title
IKDC
Description
International Knee Documentation Committee
Time Frame
12 months,
Title
IKDC
Description
International Knee Documentation Committee
Time Frame
24 months
Title
Tegner Lysholm
Description
Tegner Lysholm Knee Scoring Scale
Time Frame
12 weeks,
Title
Tegner Lysholm
Description
Tegner Lysholm Knee Scoring Scale
Time Frame
6 months
Title
Tegner Lysholm
Description
Tegner Lysholm Knee Scoring Scale
Time Frame
12 months
Title
Tegner Lysholm
Description
Tegner Lysholm Knee Scoring Scale
Time Frame
24 months
Title
SF-36
Description
The Short Form (36) Health Survey
Time Frame
12 weeks
Title
SF-36
Description
The Short Form (36) Health Survey
Time Frame
6 months
Title
SF-36
Description
The Short Form (36) Health Survey
Time Frame
12 months
Title
SF-36
Description
The Short Form (36) Health Survey
Time Frame
24 months
Title
VAS
Description
Pain Visual Analog Scale
Time Frame
12 week
Title
VAS
Description
Pain Visual Analog Scale
Time Frame
6 months
Title
VAS
Description
Pain Visual Analog Scale
Time Frame
12 months
Title
VAS
Description
Pain Visual Analog Scale
Time Frame
24 months
Title
Blood test
Description
CRP, IL-6, CTx
Time Frame
2nd day
Title
Blood test
Description
CRP, IL-6, CTx
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafał Kamiński, MD PhD
Phone
+48227794031
Ext
469
Email
kaminski@spskgruca.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafal Kaminski
Organizational Affiliation
PCME, Otwock, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital
City
Otwock
State/Province
Mazowieckie
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafal Kaminski, MD PhD
Phone
+48227794031
Ext
431
Email
rkaminski@spskgruca.pl
First Name & Middle Initial & Last Name & Degree
Stanislaw Pomianowski, MD PhD Prof
Phone
+48227794031
Ext
481
Email
spom@spskgruca.pl
12. IPD Sharing Statement
Learn more about this trial
High Tibial Osteotomy With/Without Fulkerson Osteotomy in Knee OA
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