Osteoarthritis, KneeNCT05539326
A Study of the Construct Validity of Community Walking Speed Data Collected Remotely With the Canary canturioTM te Tibial Extension
An observational study of Osteoarthritis, Knee, run by Canary Medical at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Performance Clinical Outcome Test
- How many people
- 52 participants
- Where
- 6 sitesUnited States
- Study dates
- 29 Dec 2022to 12 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Vail Summit Orthopaedics and Neurosurgery
Frisco, Colorado, 80443
Mississippi Sports Medicine and Orthopaedic Center
Jackson, Mississippi, 39202
Dr. Ballard
Oregon City, Oregon, 97045
Orthopaedic Surgery and Sports Medicine
San Antonio, Texas, 78209
South Bend Orthopaedics
South Bend, Indiana, 46635
Orthopedic NJ
Sparta, New Jersey, 07871
About this study
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
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).
Read the 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)
- Conditions
- Osteoarthritis, Knee
- Being tested
- Performance Clinical Outcome Test
- Keywords
- total knee arthroplasty, Canary canturio™te with Canary Health Implanted Reporting Processor, clinical outcomes, 4 meter walk test
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performance Clinical Outcome TestOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Performance Clinical Outcome Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 wks+2 weeks post TKA
Community Walking Speed
Average walking speed
Measured: 7 days prior to follow-up appoinment
Secondary outcomes (4)
Numeric Pain Rating Scale
Patient Reported Outcome on level of Pain
Measured: wks+2 weeks post TKA
Oxford Knee Score
Patient Reported Outcome on Clinical Function
Measured: wks+2 weeks post TKA
KOOS Jr
Patient Reported Outcome on Clinical Function
Measured: 4wks+2 weeks post TKA
Clinical Limping Evaluation
Self Evaluation of Limping
Measured: 4wks+2 weeks post TKA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start29 Dec 2022
- Primary completion12 May 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canary Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539326
- Sponsor's protocol ID
- POS-CTE-002P
- Status last verified
- Sep 2023
- First submitted
- 10 Sep 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05539326
- Acronym / sponsor ID
- POS-CTE-002P
- Conditions
- Osteoarthritis, Knee
- Keywords
- total knee arthroplasty, Canary canturio™te with Canary Health Implanted Reporting Processor, clinical outcomes, 4 meter walk test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Canary MedicalIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PIQ Patients | – | Other: Performance Clinical Outcome TestPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Performance Clinical Outcome TestPatients 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. | Other | PIQ Patients |
Primary outcome
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.
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: 1. stand up from the chair 2. walk to the line on the floor at a comfortable and safe walking speed 3. turn and walk back to the chair at a comfortable and safe walking speed 4. 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.
Community Walking Speed
Time frame: 7 days prior to follow-up appoinment
Average walking speed
4 secondary outcomes
Numeric Pain Rating Scale
Time frame: wks+2 weeks post TKA
Oxford Knee Score
Time frame: wks+2 weeks post TKA
KOOS Jr
Time frame: 4wks+2 weeks post TKA
Clinical Limping Evaluation
Time frame: 4wks+2 weeks post TKA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Canary Medical at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4 Meter Walk Test (time frame: 4 wks+2 weeks post TKA). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.