High Tibial Osteotomy With/Without Arthroscopy.
Primary Purpose
Osteoarthritis, Knee, Meniscus; Degeneration
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
HTO
Arthroscopy treatment
Micro fractures
Sponsored by
About this trial
This is an interventional health services research trial for Osteoarthritis, Knee focused on measuring HTO, Degenerative Meniscus, Osteoarthritis, Microfracture
Eligibility Criteria
Inclusion Criteria:
- Knee medial compartment or patellofemoral osteoarthritis in medical interview and physical examination
- Intraarticular lesions in MRI
- 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
- multilligament 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, Centre of Postgraduate Medical Education, Professor A. Gruca Teaching HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Sham Comparator
Active Comparator
Arm Label
High Tibial Osteotomy and arthroscopy
High Tibial Osteotomy
High Tibial Osteotomy, arthroscopy and microfractures
Arm Description
High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions.
Descending High Tibial Osteotomy with arthroscopy without treatment of intraarticular lesions.
High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions and microfracture.
Outcomes
Primary Outcome Measures
KOOS
Knee Injury and Osteoarthritis Outcome Score
KOOS
Knee Injury and Osteoarthritis Outcome Score
IKDC
International Knee Documentation Committee - Subjective Knee Evaluation Form
IKDC
International Knee Documentation Committee - Subjective Knee Evaluation Form
VAS
Visual Analog Scale
VAS
Visual Analog Scale
Blood test
no inflammatory reaction - CRP, Il-6, CTx
Blood test
no inflammatory reaction - CRP, Il-6, CTx
Blood test
no inflammatory reaction - CRP, Il-6, CTx
Secondary Outcome Measures
Kinematic MRI with [chondrogram]
Meniscus healing, cartilage quality
Kinematic MRI with [chondrogram]
Meniscus healing, cartilage quality
X-ray - Baldini projection
Patellofemoral joint measurements
X-ray - Baldini projection
Patellofemoral joint measurements
Full Information
NCT ID
NCT05128851
First Posted
July 3, 2020
Last Updated
November 9, 2021
Sponsor
Centre of Postgraduate Medical Education
1. Study Identification
Unique Protocol Identification Number
NCT05128851
Brief Title
High Tibial Osteotomy With/Without Arthroscopy.
Official Title
Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes of Hight Tibial Osteotomy With or Without Concomitant Arthroscopic Treatment of Knee Intraarticular Lesions.
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 arthroscopically repair intra-articular knee lesions in patients with early stages of Osteoarthritis.The purpose of this study is evaluate if addition of arthroscopy to HTO provides better clinical, radiological and laboratory outcomes.
Detailed Description
Intraarticular knee lesions are often in patients with early stages of osteoarthritis. The most frequent findings are degenerative meniscus/meniscal tears and cartilage degeneration. Degenerative meniscal lesions or meniscal tears are often incidental findings without any complains from patients. In the current literature there is no evidence for good clinical outcomes after arthroscopically treatment degenerative meniscus. Cartilage injuries are common in osteoarthritic knee and depending on grading of chondromalacia are usually treated by microfractures. By this time the choice of performed surgery depends on surgeons personal assessment. The investigators believe that concomitant intraarticular procedures added to HTO will provide better clinical outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Meniscus; Degeneration
Keywords
HTO, Degenerative Meniscus, Osteoarthritis, Microfracture
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High Tibial Osteotomy and arthroscopy
Arm Type
Active Comparator
Arm Description
High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions.
Arm Title
High Tibial Osteotomy
Arm Type
Sham Comparator
Arm Description
Descending High Tibial Osteotomy with arthroscopy without treatment of intraarticular lesions.
Arm Title
High Tibial Osteotomy, arthroscopy and microfractures
Arm Type
Active Comparator
Arm Description
High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions and microfracture.
Intervention Type
Procedure
Intervention Name(s)
HTO
Intervention Description
Hight Tibial Osteotomy
Intervention Type
Procedure
Intervention Name(s)
Arthroscopy treatment
Intervention Description
Arthroscopy treatment
Intervention Type
Procedure
Intervention Name(s)
Micro fractures
Intervention Description
Micro fractures
Primary Outcome Measure Information:
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 - Subjective Knee Evaluation Form
Time Frame
12 months
Title
IKDC
Description
International Knee Documentation Committee - Subjective Knee Evaluation Form
Time Frame
24 months
Title
VAS
Description
Visual Analog Scale
Time Frame
12 months
Title
VAS
Description
Visual Analog Scale
Time Frame
24 months
Title
Blood test
Description
no inflammatory reaction - CRP, Il-6, CTx
Time Frame
2 day
Title
Blood test
Description
no inflammatory reaction - CRP, Il-6, CTx
Time Frame
6 weeks
Title
Blood test
Description
no inflammatory reaction - CRP, Il-6, CTx
Time Frame
12 weeks,
Secondary Outcome Measure Information:
Title
Kinematic MRI with [chondrogram]
Description
Meniscus healing, cartilage quality
Time Frame
2 day,
Title
Kinematic MRI with [chondrogram]
Description
Meniscus healing, cartilage quality
Time Frame
24 months
Title
X-ray - Baldini projection
Description
Patellofemoral joint measurements
Time Frame
2 day
Title
X-ray - Baldini projection
Description
Patellofemoral joint measurements
Time Frame
24 months
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
Intraarticular lesions in MRI
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
multilligament 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
Phone
+48227794031
Ext
469
Email
rkaminski@spskgruca.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafał Kamiński
Organizational Affiliation
PCME, Otwock, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopaedics and Traumatology, Centre of Postgraduate 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
469
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
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High Tibial Osteotomy With/Without Arthroscopy.
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