A Biomarker Stress Test for Detection of Early Osteoarthritis
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Variable-Stiffness Shoe
Sponsored by
About this trial
This is an interventional basic science trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- age 18-80 years
- symptomatic medial compartment knee OA (KL grades 0-2)
- full weight-bearing status
- able to walk for 30 minutes or longer
- able to undergo MRI scan
- agreement and ability to use provided shoe as primary walking shoe (4 or more hours a day) during the 6 month study period
Exclusion Criteria:
- inflammatory arthritis, gout or recurrent pseudogout
- patellofemoral or lateral compartment disease that is equal to or more extensive than medial disease
- symptomatic OA of other lower extremity joints
- BMI >35 kg/m2
- prior structural surgery of the knee except for medial meniscectomy performed > 6 months prior
- use of shoe insert or hinged knee brace
- pes planus, and/or unusual foot size or shape
Sites / Locations
- VA Palo Alto
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Variable-Stiffness Shoe
Arm Description
Subjects will wear a load-modifying variable-stiffness shoe for 6 months
Outcomes
Primary Outcome Measures
Change at 6 Months From Baseline in First Peak Knee Adduction Moment (KAM): (6 Month Value - Baseline)
Knee adduction moment describes the medial/lateral load distribution of the knee measured while walking in a gait laboratory. Before normalization to account for size, the knee adduction moment is expressed in Nm. However, to account for different sized people, the knee adduction moment is transformed and expressed in percentage of body weight times height (%BW*ht). Higher knee adduction moments have been linked to more severe osteoarthritis (OA). Knee adduction moment will be analyzed at baseline and after 6 months of variable-stiffness shoe wear. Values at 6 months (in variable-stiffness shoe) will be compared to baseline (in control shoe).
Change at 6 Months From Baseline in Serum COMP Biomarker Levels in Response to a Mechanical Stimulus (6 Month - Baseline)
Serum samples were collected before and after a 30 minute walking activity. Levels of serum cartilage oligomeric matrix protein (COMP) 3.5 hours following the 30-minute walk, expressed as a percentage of pre-activity resting values, were assessed, and values at 6 months were compared to baseline.
Secondary Outcome Measures
Full Information
NCT ID
NCT02593864
First Posted
October 28, 2015
Last Updated
October 23, 2020
Sponsor
VA Palo Alto Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT02593864
Brief Title
A Biomarker Stress Test for Detection of Early Osteoarthritis
Official Title
A Novel Serum Biomarker Stress Test for Detection of Early Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Veterans have much higher risk of osteoarthritis (OA) then the general population. Knee OA is common among Veterans and is a leading cause of disability. The earliest stages of OA development, where the joint cartilage wears away, is usually painless. By the time Veterans experience symptoms, the OA is typically advanced and there is nothing that can be done except palliation until the joint is replaced with metal and plastic. If there was a blood test to provide early warning of cartilage wear and joint deterioration, Veterans could potentially be treated early enough to slow down or even prevent OA. So far, development of such a blood test has proved elusive. The investigators propose a new method to amplify the signs of cartilage wear in the blood by challenging the affected joint with a walking task. Similar to a cardiac stress test, this walking challenge may help to separate joints at risk from healthy joints. The investigators will also see if this 'OA stress test' can show if a simple and inexpensive load-modifying shoe can improve joint health in Veterans with early knee OA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Variable-Stiffness Shoe
Arm Type
Experimental
Arm Description
Subjects will wear a load-modifying variable-stiffness shoe for 6 months
Intervention Type
Device
Intervention Name(s)
Variable-Stiffness Shoe
Intervention Description
A load-modifying variable-stiffness shoe previously shown to reduce joint loading
Primary Outcome Measure Information:
Title
Change at 6 Months From Baseline in First Peak Knee Adduction Moment (KAM): (6 Month Value - Baseline)
Description
Knee adduction moment describes the medial/lateral load distribution of the knee measured while walking in a gait laboratory. Before normalization to account for size, the knee adduction moment is expressed in Nm. However, to account for different sized people, the knee adduction moment is transformed and expressed in percentage of body weight times height (%BW*ht). Higher knee adduction moments have been linked to more severe osteoarthritis (OA). Knee adduction moment will be analyzed at baseline and after 6 months of variable-stiffness shoe wear. Values at 6 months (in variable-stiffness shoe) will be compared to baseline (in control shoe).
Time Frame
Baseline to 6 months
Title
Change at 6 Months From Baseline in Serum COMP Biomarker Levels in Response to a Mechanical Stimulus (6 Month - Baseline)
Description
Serum samples were collected before and after a 30 minute walking activity. Levels of serum cartilage oligomeric matrix protein (COMP) 3.5 hours following the 30-minute walk, expressed as a percentage of pre-activity resting values, were assessed, and values at 6 months were compared to baseline.
Time Frame
Baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18-80 years
symptomatic medial compartment knee OA (KL grades 0-2)
full weight-bearing status
able to walk for 30 minutes or longer
able to undergo MRI scan
agreement and ability to use provided shoe as primary walking shoe (4 or more hours a day) during the 6 month study period
Exclusion Criteria:
inflammatory arthritis, gout or recurrent pseudogout
patellofemoral or lateral compartment disease that is equal to or more extensive than medial disease
symptomatic OA of other lower extremity joints
BMI >35 kg/m2
prior structural surgery of the knee except for medial meniscectomy performed > 6 months prior
use of shoe insert or hinged knee brace
pes planus, and/or unusual foot size or shape
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constance Chu, MD
Organizational Affiliation
VA Palo Alto Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Biomarker Stress Test for Detection of Early Osteoarthritis
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