Back to resultsA Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone
Primary Purpose
Knee Osteoarthritis
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Medial Opening Wedge High Tibial Osteotomy (HTO)
Non-Surgical Treatment Program
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, high tibial osteotomy, gait analysis, muscular strength, body composition, magnetic resonance imaging, biological markers
Eligibility Criteria
Inclusion Criteria:
Is the subject either:
- 25-55 years old?
- Older than 55 but still active (ex. physical labour, regular recreational activities)?
- Does this subject present with varus alignment? (Based on hip to ankle x-rays).
- Does this subject have clinical Knee OA? (MAA <-2° on full limb standing AP) according to the Altman classification primarily involving the medial compartment of the knee?
- Patient is a good candidate for high tibial osteotomy and will be receiving a PEEK plate, or if receiving an alternate plate, agrees to have the plate removed prior to 1 year postoperative.
Exclusion Criteria:
- Has this subject had a previous HTO or joint replacement in either limb?
- Is this subject likely to undergo bilateral HTO within the 2 year follow up period?
- Does this subject have an unstable knee or ligament?
- Does this subject have inflammatory or infectious arthritis of the knee?
- Radiographic disease too advanced for HTO (ie. diffuse lateral compartment, patellofemoral joint OA and/or severe enough disease to suggest that joint replacement is the better surgical option) and/or Kellgren and Lawrence grade 4.
- The subject's disease is not advanced enough (symptomatically or radiographically) to warrant HTO.
- Does this subject have a major medical illness with life expectancy <2 years or with an unacceptably high operative risk?
- Does this subject have a major neurological deficit that would affect gait?
- Is this subject possibly pregnant or planning pregnancy?
- Is this subject unable to read English?
- Does this subject have a psychiatric illness that limits informed consent?
- Is the subject unlikely to comply with study protocol?
Sites / Locations
- Fowler Kennedy Sport Medicine Clinic, Western University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Non-Surgical Treatment plus HTO
Non-Surgical Treatment
Arm Description
The optimized non-surgical treatment program consists of medications, physiotherapy and nutritional seminars. The 12-week program will include an assessment by a primary care physician, physiotherapist and orthopaedic surgeon, one supervised physiotherapy session per week, one body recomposition session per week, and a home program. After the 12-week program is completed, patients randomized to this group will undergo a medial opening wedge high tibial osteotomy (HTO). They will continue with their home program and will be followed up for 2 years after baseline.
The optimized non-surgical treatment program consists of medications, physiotherapy and nutritional seminars. The 12-week program will include an assessment by a primary care physician, physiotherapist and orthopaedic surgeon, one supervised physiotherapy session per week, one body recomposition session per week, and a home program. After the 12-week program is completed, patients randomized to this group will continue with their home program and will be followed up for 2 years after baseline.
Outcomes
Primary Outcome Measures
MRI articular cartilage morphology
3 Tesla MRI measure of medial tibiofemoral articular cartilage thickness
Secondary Outcome Measures
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient-reported outcome measure. 5 subdomains: pain, symptoms, activities of daily living, sport and recreation, quality of life
Western Ontario Meniscal Evaluation Tool (WOMET)
Patient-reported outcome measure. Assesses health-related quality of life (HRQoL) in patients with meniscal tears. 3 dimensions: physical symptoms, sports/recreation/work/lifestyle, emotions
Biological Markers of Disease Progression
Synovial fluid, serum and urine biological markers
Numeric Rating Scale for Pain
Patient-reported outcome measure. Assesses patient's pain. 0 (no pain) - 10 (worst possible pain)
Gait Biomechanics
Knee frontal, sagittal and transverse plane kinematics and kinetics tested during level walking in a motion analysis laboratory. The measure of most interest is the peak external knee adduction moment during stance phase of walking.
Isometric Strength Testing
Isometric quadriceps and hamstrings strength tested using an isokinetic dynamometer.
Intermittent and Constant Osteoarthritis Pain Index (ICOAP)
Patient-reported outcome measure. Assesses pain in individuals with hip or knee osteoarthritis taking into account both constant and intermittent pain. 3 domains: intermittent pain, constant pain, total pain
Short-Form 12 (SF12)
Patient-reported outcome measure. Self-reported outcome measure assessing the impact of health on an individual's everyday life
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Patient-reported outcome measure. 3 sub domains: pain, symptoms, function
Full Information
NCT ID
NCT02003976
First Posted
December 2, 2013
Last Updated
July 14, 2022
Sponsor
Western University, Canada
Collaborators
The Arthritis Society, Canada, Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT02003976
Brief Title
A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone
Official Title
A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada
Collaborators
The Arthritis Society, Canada, Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare patients with knee osteoarthritis (OA) receiving optimized non-surgical treatment plus surgical realignment of the tibia, or optimized non-surgical treatment only. We hypothesize that outcomes assessed at 12 and 24 months follow-up will suggest favourable changes in patients undergoing surgical realignment when compared to patients receiving non-surgical treatment only.
Detailed Description
This two groups, parallel design randomized controlled trial will compare patients with medial compartment knee OA and varus alignment receiving optimized non-surgical treatment plus High Tibial Osteotomy (HTO) to similar patients receiving optimized non-surgical treatment only. All participants will receive non-surgical treatment that will be individualized to the patient and include medications, physiotherapy and nutritional seminars. The non-surgical treatment will include supervised physiotherapy and nutritional seminars once per week for 12 weeks, will be accompanied and followed by a home program, and follow-up appointments for potential modification every three months for the duration of the study. Participants randomized to surgery will also undergo medial opening wedge HTO after 12 weeks of optimized non-surgical treatment. Both groups will follow the same schedule of clinic visits throughout the 24 month follow-up period. MRI-derived measures of articular cartilage morphology, biological markers of articular cartilage degradation and synthesis, gait biomechanics and patient-reported outcomes will be assessed at baseline, 12 and 24 months follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, high tibial osteotomy, gait analysis, muscular strength, body composition, magnetic resonance imaging, biological markers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-Surgical Treatment plus HTO
Arm Type
Experimental
Arm Description
The optimized non-surgical treatment program consists of medications, physiotherapy and nutritional seminars. The 12-week program will include an assessment by a primary care physician, physiotherapist and orthopaedic surgeon, one supervised physiotherapy session per week, one body recomposition session per week, and a home program. After the 12-week program is completed, patients randomized to this group will undergo a medial opening wedge high tibial osteotomy (HTO). They will continue with their home program and will be followed up for 2 years after baseline.
Arm Title
Non-Surgical Treatment
Arm Type
Active Comparator
Arm Description
The optimized non-surgical treatment program consists of medications, physiotherapy and nutritional seminars. The 12-week program will include an assessment by a primary care physician, physiotherapist and orthopaedic surgeon, one supervised physiotherapy session per week, one body recomposition session per week, and a home program. After the 12-week program is completed, patients randomized to this group will continue with their home program and will be followed up for 2 years after baseline.
Intervention Type
Procedure
Intervention Name(s)
Medial Opening Wedge High Tibial Osteotomy (HTO)
Intervention Description
A lower limb realignment surgery to redistribute load away from the most affected portion of the knee.
Intervention Type
Other
Intervention Name(s)
Non-Surgical Treatment Program
Intervention Description
A 12-week optimized non-surgical treatment program consisting of medication, physiotherapy and nutritional seminars.
Primary Outcome Measure Information:
Title
MRI articular cartilage morphology
Description
3 Tesla MRI measure of medial tibiofemoral articular cartilage thickness
Time Frame
Change from baseline to 24 months post operative
Secondary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Patient-reported outcome measure. 5 subdomains: pain, symptoms, activities of daily living, sport and recreation, quality of life
Time Frame
Change from baseline to 24 months post operative
Title
Western Ontario Meniscal Evaluation Tool (WOMET)
Description
Patient-reported outcome measure. Assesses health-related quality of life (HRQoL) in patients with meniscal tears. 3 dimensions: physical symptoms, sports/recreation/work/lifestyle, emotions
Time Frame
Change from baseline to 24 months post operative
Title
Biological Markers of Disease Progression
Description
Synovial fluid, serum and urine biological markers
Time Frame
Baseline, 12 and 24 months post operative
Title
Numeric Rating Scale for Pain
Description
Patient-reported outcome measure. Assesses patient's pain. 0 (no pain) - 10 (worst possible pain)
Time Frame
Baseline, 12 and 24 months post operative
Title
Gait Biomechanics
Description
Knee frontal, sagittal and transverse plane kinematics and kinetics tested during level walking in a motion analysis laboratory. The measure of most interest is the peak external knee adduction moment during stance phase of walking.
Time Frame
Baseline, 12 and 24 months post operative
Title
Isometric Strength Testing
Description
Isometric quadriceps and hamstrings strength tested using an isokinetic dynamometer.
Time Frame
Baseline, 12 and 24 months post operative
Title
Intermittent and Constant Osteoarthritis Pain Index (ICOAP)
Description
Patient-reported outcome measure. Assesses pain in individuals with hip or knee osteoarthritis taking into account both constant and intermittent pain. 3 domains: intermittent pain, constant pain, total pain
Time Frame
Change from baseline to 24 months post operative
Title
Short-Form 12 (SF12)
Description
Patient-reported outcome measure. Self-reported outcome measure assessing the impact of health on an individual's everyday life
Time Frame
Change from baseline to 24 months post operative
Title
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
Patient-reported outcome measure. 3 sub domains: pain, symptoms, function
Time Frame
Change from baseline to 24 months post operative
Other Pre-specified Outcome Measures:
Title
Cost-effectiveness questionnaires
Description
Collection of accumulated direct and indirect costs related to the intervention incurred over the study period as reported by the patient.
Time Frame
Baseline and every 3 months from baseline up to 24 months post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is the subject either:
25-55 years old?
Older than 55 but still active (ex. physical labour, regular recreational activities)?
Does this subject present with varus alignment? (Based on hip to ankle x-rays).
Does this subject have clinical Knee OA? (MAA <-2° on full limb standing AP) according to the Altman classification primarily involving the medial compartment of the knee?
Patient is a good candidate for high tibial osteotomy and will be receiving a PEEK plate, or if receiving an alternate plate, agrees to have the plate removed prior to 1 year postoperative.
Exclusion Criteria:
Has this subject had a previous HTO or joint replacement in either limb?
Is this subject likely to undergo bilateral HTO within the 2 year follow up period?
Does this subject have an unstable knee or ligament?
Does this subject have inflammatory or infectious arthritis of the knee?
Radiographic disease too advanced for HTO (ie. diffuse lateral compartment, patellofemoral joint OA and/or severe enough disease to suggest that joint replacement is the better surgical option) and/or Kellgren and Lawrence grade 4.
The subject's disease is not advanced enough (symptomatically or radiographically) to warrant HTO.
Does this subject have a major medical illness with life expectancy <2 years or with an unacceptably high operative risk?
Does this subject have a major neurological deficit that would affect gait?
Is this subject possibly pregnant or planning pregnancy?
Is this subject unable to read English?
Does this subject have a psychiatric illness that limits informed consent?
Is the subject unlikely to comply with study protocol?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trevor B Birmingham, PT, PhD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J R Giffin, MD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fowler Kennedy Sport Medicine Clinic, Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone
We'll reach out to this number within 24 hrs