CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Variable-Stiffness Shoedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02593864
NCT02593864N/ACompleted

A Novel Serum Biomarker Stress Test for Detection of Early Osteoarthritis

VA Palo Alto Health Care System·interventional·Posted Nov 2, 2015·Updated Nov 20, 2020

In Brief

A clinical study evaluating Variable-Stiffness Shoe for Osteoarthritis. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2, 2015
Enrollment StartFeb 1, 2016
Primary CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.7 years ago

Interventions

Variable-Stiffness Shoedevice

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