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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Canary Medical
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Knee
Additional Details

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)

Arms & Interventions


: 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Frisco, Colorado




Vail Summit Orthopaedics and Neurosurgery

Frisco, Colorado, 80443

Site Contact

Jared Heinz

[email protected]


South Bend Orthopaedics, South Bend, Indiana




South Bend Orthopaedics

South Bend, Indiana, 46635

Site Contact

Derek Yocum, PhD

[email protected]


Jackson, Mississippi




Mississippi Sports Medicine and Orthopaedic Center

Jackson, Mississippi, 39202

Site Contact

Doug Parsell

[email protected]


Orthopedic NJ, Sparta, New Jersey




Orthopedic NJ

Sparta, New Jersey, 07871

Site Contact

John Dundon, MD


Dr. Ballard, Oregon City, Oregon




Dr. Ballard

Oregon City, Oregon, 97045

Site Contact

Annette Tieu

[email protected]


Orthopaedic Surgery and Sports Medicine, San Antonio, Texas




Orthopaedic Surgery and Sports Medicine

San Antonio, Texas, 78209

Site Contact

Andrew Whaley, MD