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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Variable-Stiffness Shoe | Experimental | Subjects will wear a load-modifying variable-stiffness shoe for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Variable-Stiffness Shoe | Device | A load-modifying variable-stiffness shoe previously shown to reduce joint loading |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 6 months |
| 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. | Baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Constance Chu, MD | VA Palo Alto Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto | Palo Alto | California | 94304 | United States |
X-ray screening for inclusion/exclusion criteria
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| ID | Title | Description |
|---|---|---|
| FG000 | Variable-Stiffness Shoe | Subjects will wear a load-modifying variable-stiffness shoe for 6 months Variable-Stiffness Shoe: A load-modifying variable-stiffness shoe previously shown to reduce joint loading |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants assigned to the variable-stiffness shoe
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| ID | Title | Description |
|---|---|---|
| BG000 | Variable-Stiffness Shoe | Subjects will wear a load-modifying variable-stiffness shoe for 6 months Variable-Stiffness Shoe: A load-modifying variable-stiffness shoe previously shown to reduce joint loading |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | These results were based on gait data for 18 subjects that was available at both the baseline and follow-up visits | Posted | Mean | Standard Deviation | %Bw*Ht | Baseline to 6 months |
|
6 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Variable-Stiffness Shoe | Subjects will wear a load-modifying variable-stiffness shoe for 6 months Variable-Stiffness Shoe: A load-modifying variable-stiffness shoe previously shown to reduce joint loading |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint paint | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Related and Un-related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Constance Chu, MD | Stanford University | 650-723-5643 | chucr@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2019 | Oct 2, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Knee Adduction Moment | 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). | Per protocol cohort. Baseline value of subjects who completed the 6 month study visit. Gait data unusable for 1 subject at follow-up, and this subject was not included in the baseline value. | Mean | Standard Deviation | %Bw*Ht |
|
| COMP at 3.5 Hours (% Of Baseline Resting) | 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. | Per protocol cohort. These analyses are based on available data from 15 subjects who completed both the baseline and follow-up visits for analysis of changes in COMP. Biomarker data for one subject was missing at baseline, and complete biomarker data for 3 subjects was unable to be collected at follow-up. | Mean | Standard Deviation | % Of Resting |
|
Subjects will wear a load-modifying variable-stiffness shoe for 6 months Variable-Stiffness Shoe: A load-modifying variable-stiffness shoe previously shown to reduce joint loading |
|
|
| Primary | 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. | These analyses were based on available data from 15 subjects at both the baseline and follow-up visits for analysis of changes in COMP | Posted | Mean | Standard Deviation | Percent of Resting | Baseline to 6 months |
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