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

Completed

Conditions studied: Osteoarthritis, Knee

In brief

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).

Key facts

Study ID

NCT05539326

Run by

Canary Medical

People needed

52

Starts

2022-12-29

Expected to finish

2023-05-12

Last updated by the study team

2023-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patient must be 18 years of age or older at the time of surgery
• Patient is scheduled for or has undergone primary total knee arthroplasty using a Persona Personalized Knee System with Canary Tibial Extension (PIQ) TKA implant according to the appropriate surgical technique and IFU.
• Patient must be willing and able to complete the protocol required follow-up
• Patient has participated in the study-related informed consent process
• Patient has a platform-compatible personal computer located in their dwelling with substantially reliable wireless internet access and a USB port

You may not qualify if…

• Simultaneous bilateral TKA
• Staged bilateral TKA less than 6 months from indexed procedure
• Patient is a current alcohol or drug abuser
• Patient is known to be pregnant, breastfeeding, or considered a member of a protected class (e.g., prisoner, mentally incompetent, etc.)
• Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent and participation in follow-up program
• Patient has previous history of infection in the affected joint and/or a local or systemic infection that may affect the prosthetic joint
• Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions
• Patient with Neuropathic Arthropathy
• Patient has rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
• Patient is undergoing procedures or treatments using ionizing radiation
• Patient has a known or suspected sensitivity to one or more of the implant materials.
• Patients with known orthopaedic lower extremity, spinal and/or neurologic conditions that could affect gait

Where it is running

• Vail Summit Orthopaedics and Neurosurgery — Frisco, Colorado, United States
• South Bend Orthopaedics — South Bend, Indiana, United States
• Mississippi Sports Medicine and Orthopaedic Center — Jackson, Mississippi, United States
• Orthopedic NJ — Sparta, New Jersey, United States
• Dr. Ballard — Oregon City, Oregon, United States
• Orthopaedic Surgery and Sports Medicine — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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