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

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).

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: Performance Clinical Outcome Test

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)

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Frisco, Colorado, United States, 80443
      • Vail Summit Orthopaedics and Neurosurgery
  • Indiana
    • South Bend, Indiana, United States, 46635
      • South Bend Orthopaedics
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Mississippi Sports Medicine and Orthopaedic Center
  • New Jersey
    • Sparta, New Jersey, United States, 07871
      • Orthopedic NJ
  • Oregon
    • Oregon City, Oregon, United States, 97045
      • Dr. Ballard
  • Texas
    • San Antonio, Texas, United States, 78209
      • Orthopaedic Surgery and Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

PIQ Patients; Patient is scheduled for or has undergone primary total knee arthroplasty (TKA) using a Persona Personalized Knee System with Canary Tibial Extension (PIQ) TKA implant according to the appropriate surgical technique and IFU. If you decide to take part in this research study, the general procedures include one follow-up visit where you will be asked to complete two performance-based tests that are used to assess your physical function following Total Knee Arthroplasty ("TKA"). As part of your standard of care, you will receive a Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension. As part of this study, subjects will be asked to perform two performance based tests called the 4 meter walk test and the timed up and go test. Subjects will also be asked to complete a series of patient questionnaires that will assess their post-operative function.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Community Walking Speed	Average walking speed	7 days prior to follow-up appoinment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Rating Scale	Patient Reported Outcome on level of Pain	wks+2 weeks post TKA
Oxford Knee Score	Patient Reported Outcome on Clinical Function	wks+2 weeks post TKA
KOOS Jr	Patient Reported Outcome on Clinical Function	4wks+2 weeks post TKA
Clinical Limping Evaluation	Self Evaluation of Limping	4wks+2 weeks post TKA

Collaborators and Investigators

• Sponsor: Canary Medical

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2022
• Primary Completion (Actual): May 12, 2023
• Study Completion (Actual): May 12, 2023

Study Registration Dates

• First Submitted: September 10, 2022
• First Submitted That Met QC Criteria: September 10, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: total knee arthroplasty; clinical outcomes; Canary canturio™te with Canary Health Implanted Reporting Processor; 4 meter walk test
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: POS-CTE-002P

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No