Clinical trial NCT05539326: A Study of the Construct Validity of Community Walking Speed Data Collected Remotely With the Canary canturioTM te Tibial Extension
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Keywords: total knee arthroplasty
Canary canturio™te with Canary Health Implanted Reporting Processor
clinical outcomes
4 meter walk test
Lead sponsor: Canary Medical
Sponsor class: INDUSTRY
First posted: 2022-09-14
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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)

Eligibility criteria: 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

Primary outcomes:
measure: 4 Meter Walk Test
timeFrame: 4 wks+2 weeks post TKA
measure: Timed Up and Go Test *(TUG)
timeFrame: 4 wks+2 weeks post TKA
measure: Community Walking Speed
timeFrame: 7 days prior to follow-up appoinment
Secondary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: wks+2 weeks post TKA
measure: Oxford Knee Score
timeFrame: wks+2 weeks post TKA
measure: KOOS Jr
timeFrame: 4wks+2 weeks post TKA
measure: Clinical Limping Evaluation
timeFrame: 4wks+2 weeks post TKA
Other outcomes:
Locations:
city: Frisco
country: United States
facility: Vail Summit Orthopaedics and Neurosurgery
state: Colorado
city: South Bend
country: United States
facility: South Bend Orthopaedics
state: Indiana
city: Jackson
country: United States
facility: Mississippi Sports Medicine and Orthopaedic Center
state: Mississippi
city: Sparta
country: United States
facility: Orthopedic NJ
state: New Jersey
city: Oregon City
country: United States
facility: Dr. Ballard
state: Oregon
city: San Antonio
country: United States
facility: Orthopaedic Surgery and Sports Medicine
state: Texas
Study officials:
References: