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A Biomarker Stress Test for Detection of Early Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02593864
Recruitment Status : Active, not recruiting
First Posted : November 2, 2015
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Constance Chu, VA Palo Alto Health Care System

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Variable-Stiffness Shoe Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Novel Serum Biomarker Stress Test for Detection of Early Osteoarthritis
Actual Study Start Date : February 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Variable-Stiffness Shoe
Subjects will wear a load-modifying variable-stiffness shoe for 6 months
Device: Variable-Stiffness Shoe
A load-modifying variable-stiffness shoe previously shown to reduce joint loading




Primary Outcome Measures :
  1. Change at 6 months from baseline in serum biomarker levels in response to a mechanical stimulus [ Time Frame: Baseline to 6 months ]
    Serum samples will be collected before and repeatedly after a 30 minute walking activity. Levels of serum biomarkers will be assessed, and values at 6 months will be compared to baseline.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593864


Locations
United States, California
VA Palo Alto
Palo Alto, California, United States, 94304
Sponsors and Collaborators
VA Palo Alto Health Care System
Investigators
Principal Investigator: Constance Chu, MD VA Palo Alto Health Care System

Responsible Party: Constance Chu, Director, Joint Preservation Center, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT02593864     History of Changes
Other Study ID Numbers: 1I21RX002045 ( U.S. NIH Grant/Contract )
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases