NCT05539326

A Study of the Construct Validity of Community Walking Speed Data Collected Remotely With the Canary canturioTM te Tibial Extension

A Multicenter, Single- Arm Postmarket Study of the Construct Validity of Community Walking Speed Data Collected Remotely With the Canary canturioTM te Tibial Extension

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: Canary Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the construct validity of the Canary Tibial Extension's measure of self-selected community walking speed. Construct validity will be assessed by the Pearson's correlation coefficient between self-selected community walking speed and the 4-meter walk test. The objective of this multicenter, prospective study is to demonstrate that remote measurement of community walking speed with the Canary canturioTM (CTE) tibial extension is correlated with the fast 4-meter walk test (4mWT).

Detailed description

The primary endpoint is community walking speed, calculated as a mean, remotely captured over the 7 days prior to the patient's regularly scheduled office visit: specifically, the correlation (Pearson correlation coefficient) of community walking speed with the 4mWT. The secondary endpoints are as follows: * Correlation coefficient between community walking speed and the Timed Up and Go (TUG) Test * Completeness of data collection and transmission by the study device * Correlation coefficient between community walking speed and the Oxford Knee Score * Correlation coefficient between community walking speed and the Knee Injury and Osteoarthritis Outcome Score Jr (KOOS JR)

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
OTHER	Performance Clinical Outcome Test	Patients will be asked to perform a fast 4-meter walk test (4mWT) and the Timed up and Go (TUG) test in the clinic during their post-operative follow-up visit. Both performance exams will be performed in a controlled environment within the physician's clinic.

Timeline

• Start date: 2022-12-29
• Primary completion: 2023-05-12
• Completion: 2023-05-12
• First posted: 2022-09-14
• Last updated: 2023-09-21

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study