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Completed

NCT Number: NCT05539326

A 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).

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vail Summit Orthopaedics and Neurosurgery, Frisco, Colorado, United States

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About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Performance Clinical Outcome Test

Other

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.

Primary outcomes

  1. 4 Meter Walk Test

    Time frame: 4 wks+2 weeks post TKA

    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.

  2. Timed Up and Go Test *(TUG)

    Time frame: 4 wks+2 weeks post TKA

    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.

  3. Community Walking Speed

    Time frame: 7 days prior to follow-up appoinment

    Average walking speed

Secondary outcomes

  1. Numeric Pain Rating Scale

    Time frame: wks+2 weeks post TKA

    Patient Reported Outcome on level of Pain

  2. Oxford Knee Score

    Time frame: wks+2 weeks post TKA

    Patient Reported Outcome on Clinical Function

  3. KOOS Jr

    Time frame: 4wks+2 weeks post TKA

    Patient Reported Outcome on Clinical Function

  4. Clinical Limping Evaluation

    Time frame: 4wks+2 weeks post TKA

    Self Evaluation of Limping

Sponsors and collaborators

Lead sponsor

Canary Medical

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2022
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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