A Biomarker Stress Test for Detection of Early Osteoarthritis

NCT ID: NCT02593864

Last Updated: 2020-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-07-31

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Variable-Stiffness Shoe

Subjects will wear a load-modifying variable-stiffness shoe for 6 months

Group Type: EXPERIMENTAL

Variable-Stiffness Shoe

Intervention Type: DEVICE

A load-modifying variable-stiffness shoe previously shown to reduce joint loading

Interventions

Variable-Stiffness Shoe

A load-modifying variable-stiffness shoe previously shown to reduce joint loading

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Palo Alto Health Care System

FED

Sponsor Role: lead

Responsible Party

Constance Chu, MD

Director, Joint Preservation Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Constance Chu, MD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System

Locations

VA Palo Alto

Palo Alto, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1I21RX002045

Identifier Type: NIH

Identifier Source: org_study_id

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