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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05539326
• Other study ID #: POS-CTE-002P
• Status: Completed
• Start date: December 29, 2022
• Est. completion date: May 12, 2023

Study information

• Verified date: September 2023
• Source: Canary Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 12, 2023
• Est. primary completion date: May 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Canary Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4 Meter Walk Test	A 4MWT test will be performed in the physician's clinic along a clear pathway of at least 8 in length in a designated area over solid flooring. The 8-m distance will be measured with a starting (0m) and an end point (8m) with additional marks at 2m and 6m to identify the 4m which is the timed portion of the test. A handheld, calibrated stopwatch will be used as the gold standard for measuring walking speed output during the 4 mWT, measuring the time it takes to complete the test.	4 wks+2 weeks post TKA
Primary	Timed Up and Go Test *(TUG)	Patients may use a walking aid if needed. Patients will begin by sitting back in a standard armchair. Investigator will identify a line 3 meters (9.8 feet) away on the floor. When the investigator says "go" the patient will: stand up from the chair; walk to the line on the floor at a comfortable and safe walking speed; turn and walk back to the chair at a comfortable and safe walking speed; Sit down again A stopwatch will be used to record the time it takes from the initiation of the exam on the word "go" to the end of the exam when the patient's buttocks touch the seat.	4 wks+2 weeks post TKA
Primary	Community Walking Speed	Average walking speed	7 days prior to follow-up appoinment
Secondary	Numeric Pain Rating Scale	Patient Reported Outcome on level of Pain	wks+2 weeks post TKA
Secondary	Oxford Knee Score	Patient Reported Outcome on Clinical Function	wks+2 weeks post TKA
Secondary	KOOS Jr	Patient Reported Outcome on Clinical Function	4wks+2 weeks post TKA
Secondary	Clinical Limping Evaluation	Self Evaluation of Limping	4wks+2 weeks post TKA