Back to resultsLoaded and Unloaded Magnetic Resonance (MR) Imaging of Meniscus-Cartilage-Trabecular Bone in Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gait Retraining
Sponsored by
About this trial
This is an interventional prevention trial for Knee Osteoarthritis focused on measuring knee OA
Eligibility Criteria
Inclusion Criteria:
- Men and women
- At least 35 years of age
- Mild OA patients with arthritic knee symptoms and KL score of 1-2
- Severe OA patients with arthritic knee symptoms and KL score of 3-4
- Knee symptoms in OA patients is defined as pain, aching, or stiffness on most days of a month during the past year or use of medication for treatment of knee pain on most days of a month during the past year
- self reported knee pain (defined as medial compartment knee pain at least 1 day per week during each of the 6 weeks prior to participation) and at least 3 of the following 6 clinical indicators: Age>50 years; morning stiffness<30 minutes duration; crepitus on active motion; tenderness of the bony margins of the knee joint; bony enlargement at the knee; and lack of palpable warmth of the synovium
Exclusion Criteria:
- current use of investigational drug
- conditions other than OA which limit lower extremity function and mobility and/or would confound the evaluation of function (e.g., clinically significant spinal disc degeneration, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy, trochanteric bursitis, hip pain, lumbar pain)
- Patients with metallic fragments in the eyes, vascular clips, pacemakers, and other contraindications to MRI
- History of joint replacement, intra-articular fracture, osteotomy, arthroplasty or meniscectomy of the signal knee
- History of other disease that may involve the study joint including systemic inflammatory disease, crystalline disease, knee infection of the signal knee, avascular necrosis, Paget's disease or tumors
- Self reported heart condition that limits any daily physical activity
- Patients who are pregnant
Sites / Locations
- China Basin Imaging Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Moderate gait retraining
Mild gait retraining
Arm Description
a moderate 7 degree toe-in modification
A 2 degree toe-in gait retraining
Outcomes
Primary Outcome Measures
Effects of moderate versus mild gait retraining on pain, function,and kinematics and kinetics during gait and stair climing in persons with symptomatic knee OA
Everybody walks a little different. Some people walk with their toes pointed outwards (duck-footed) and other with their toes pointed straight or even inward(pigeon-toed). We will work with participants to teach you how to walk with slightly different toe angle. Participants will be randomly assign to each group and will be taught on this new walking pattern.
Gait modification is a non-surgical treatment that can reduce the KAM (knee adduction moment). Changes to foot progression angle, tibia angle, hip adduction/internal rotation and trunk sway can reduce the KAM from baseline. Modifications involving simultaneous changes to multiple gait parameters have also been shown to reduce KAM.
Secondary Outcome Measures
Full Information
NCT ID
NCT01919736
First Posted
July 29, 2013
Last Updated
November 14, 2019
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01919736
Brief Title
Loaded and Unloaded Magnetic Resonance (MR) Imaging of Meniscus-Cartilage-Trabecular Bone in Osteoarthritis
Official Title
Loaded and Unloaded Magnetic Resonance (MR) Imaging of Meniscus-Cartilage-Trabecular Bone in Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this project is to determine the effects of gait-retraining on articular cartilage composition, gait mechanics, pain and function in persons with mild to moderate knee osteoarthritis (OA).
Detailed Description
Variables of gait mechanics during walking have been linked to the onset and progression of knee osteoarthritis (OA). The knee adduction moment is one key variable that has been identified as an important indicator of medial compartment loads across the knee joint. Use of gait-retraining strategies to alter gait movement patterns and lower the knee adduction movement in persons with knee OA is a new and promising direction for the potential intervention in a population in which few strategies have worked successfully.
Factors that affect cartilage composition are crucial to understanding the disease mechanisms in knee OA. A multi-scale approach towards understanding the knee OA disease process by evaluating tissue compositional changes, joint contact mechanics, whole-body neuromuscular dynamics, and functional performance. The results will be the first to show the association between cartilage composition and daily function (performance and patterns) which are implicated in OA development and progression. With the addition of comprehensive muscle testing (cross sectional area/volume assessment using MR, strength testing, muscle activation and co-contraction patterns during daily activities), it will be possible to study the interaction between all major tissues around the knee.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee OA
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moderate gait retraining
Arm Type
Active Comparator
Arm Description
a moderate 7 degree toe-in modification
Arm Title
Mild gait retraining
Arm Type
Active Comparator
Arm Description
A 2 degree toe-in gait retraining
Intervention Type
Behavioral
Intervention Name(s)
Gait Retraining
Primary Outcome Measure Information:
Title
Effects of moderate versus mild gait retraining on pain, function,and kinematics and kinetics during gait and stair climing in persons with symptomatic knee OA
Description
Everybody walks a little different. Some people walk with their toes pointed outwards (duck-footed) and other with their toes pointed straight or even inward(pigeon-toed). We will work with participants to teach you how to walk with slightly different toe angle. Participants will be randomly assign to each group and will be taught on this new walking pattern.
Gait modification is a non-surgical treatment that can reduce the KAM (knee adduction moment). Changes to foot progression angle, tibia angle, hip adduction/internal rotation and trunk sway can reduce the KAM from baseline. Modifications involving simultaneous changes to multiple gait parameters have also been shown to reduce KAM.
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women
At least 35 years of age
Mild OA patients with arthritic knee symptoms and KL score of 1-2
Severe OA patients with arthritic knee symptoms and KL score of 3-4
Knee symptoms in OA patients is defined as pain, aching, or stiffness on most days of a month during the past year or use of medication for treatment of knee pain on most days of a month during the past year
self reported knee pain (defined as medial compartment knee pain at least 1 day per week during each of the 6 weeks prior to participation) and at least 3 of the following 6 clinical indicators: Age>50 years; morning stiffness<30 minutes duration; crepitus on active motion; tenderness of the bony margins of the knee joint; bony enlargement at the knee; and lack of palpable warmth of the synovium
Exclusion Criteria:
current use of investigational drug
conditions other than OA which limit lower extremity function and mobility and/or would confound the evaluation of function (e.g., clinically significant spinal disc degeneration, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy, trochanteric bursitis, hip pain, lumbar pain)
Patients with metallic fragments in the eyes, vascular clips, pacemakers, and other contraindications to MRI
History of joint replacement, intra-articular fracture, osteotomy, arthroplasty or meniscectomy of the signal knee
History of other disease that may involve the study joint including systemic inflammatory disease, crystalline disease, knee infection of the signal knee, avascular necrosis, Paget's disease or tumors
Self reported heart condition that limits any daily physical activity
Patients who are pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharmila Majumdar, PhD
Organizational Affiliation
UCSF, Department of Radiology and Biomedical Imaging
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Basin Imaging Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Loaded and Unloaded Magnetic Resonance (MR) Imaging of Meniscus-Cartilage-Trabecular Bone in Osteoarthritis
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