A Biomarker Stress Test for Detection of Early Osteoarthritis

Completed · Not applicable

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT02593864

Run by

VA Palo Alto Health Care System

People needed

25

Starts

2016-02-01

Expected to finish

2018-07-01

Last updated by the study team

2020-11-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Palo Alto — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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