Arthritis KneeNCT05693818
Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension
An observational study of Arthritis Knee, run by Canary Medical at 1 site in United States.
Trial summary
The objective of this prospective study is to demonstrate accuracy of a limp detection model using a healthcare provider assessment as the non-reference standard. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis Knee
- What is being tested?
- Clinical Limping Evalution
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2023to 15 May 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients indicated for a commercially available PIQ TKA implant who meet the inclusion and exclusion criteria.
Who may be able to join
- • Patient must be 18 years of age or older
- Independent of study participation, patient is indicated for a commercially available PIQ TKA implant in accordance with product labeling
- Patient must be willing and able to complete the protocol required follow-up
- Patient has participated in the study-related informed consent process
- Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved informed consent
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 with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions
Show all 9Show fewer
- Patient with Neuropathic Arthropathy
- Patient with any loss of musculature or neuromuscular disease that compromises the affected limb
- Patients with known symptomatic foot, hip or spinal injuries and/or conditions that could affect gait
Trial locations and contacts
1 site in 1 country.
Nora York contact
United States1 site, 1 recruiting
- Recruiting
Carolina Orthopaedic & Neurosurgical Associates
Spartanburg, South Carolina, 29303
Daniel Gerscovich, MD, 864-582-6396
Daniel Gerscovich, MD
About this study
Official title: A Multicenter, Single- Arm Study of Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension
The objective of this prospective study is to demonstrate accuracy of a limp detection model using a healthcare provider assessment as the non-reference standard.
Read the detailed description
The primary endpoint of the study is limp severity at the 4-6 week office visit. At 4-6 weeks (+/- 3 days) post-surgery, the healthcare team will assess the patient's limp severity by visual observation on a 3-point Likert scale (0=No limp, 1=Mild/Moderate or 2=Severe).
- Conditions
- Arthritis Knee
- Being tested
- Clinical Limping Evalution
- Keywords
- total knee arthroplasty, PersonaIQ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Limping EvalutionOther
Also called Limp Detection
Patients will be asked to perform a Clinical Limping Evaluation in the clinic during their post-operative follow-up visit. This will be performed in a controlled environment within the physician's clinic. Each patient will be asked to walk at their normal walking speed down a hallway for at least 7 consecutive steps and back toward the physician. Walking down the hallway and back is one walking trial. Each patient will be asked to perform 2 walking trials. The health care provider will assess the patient's limp using a 3-point Likert scale (0=No limp, 1=mild/moderate limp, 2=severe limp).
If required, patients may use an assistive device and the type of device should be documented. If a patient requires assistance, only the minimum amount of assistance required for a patient to complete the task should be provided.
| Study group | Role | What they receive |
|---|---|---|
| PersonaIQ | Patients indicated for a PersonaIQ total knee arthroplasty Receives: Other: Clinical Limping Evalution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limp Severity
The primary endpoint of the study is limp severity at the 4-6 week office visit. At 4-6 weeks (+/- 3 days) post-surgery, the healthcare team will assess the patient's limp severity by visual observation on a 3-point Likert scale (0=No limp, 1=Mild/Moderate or 2=Severe).
Measured: 4-6 wks+3 days weeks post TKA
Secondary outcomes (7)
Test-retest reliability of the Canary Medical Limping Model (CMLM) score
Test-retest reliability of the CMLM score from day-to-day and week-to-week. (Specific days and weeks will be provided in the Statistical Analysis Plan.)
Measured: 4-6 wks+3 days weeks post TKA
Positive Percent Agreement (PPA) of the CMLM with the healthcare team's assessment
Positive Percent Agreement (PPA)
Measured: 4-6 wks+3 days weeks post TKA
Negative Percent Agreement (NPA) of the CMLM with the healthcare team's assessment
Negative Percent Agreement (NPA)
Measured: 4-6 wks+3 days weeks post TKA
Knee Range of Motion
ROM will be measured by a goniometer
Measured: 4-6 wks+3 days weeks post TKA
Numeric Pain Rating Scale
Subjective Pain Measurement
Measured: 4-6 wks+3 days weeks post TKA
KOOS Jr
Patient Reported outcome
Measured: 4-6 wks+3 days weeks post TKA
Limping Self Evaluation
Study participants will be asked the following question, "During the past week, have you been limping when walking, because of your knee?" The following answers will be allowed:
- Rarely / never
- Sometimes or just at first, after sitting for a long time
- Often, not just at first
- Most of the time
- All of the time
Measured: 4-6 wks+3 days 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 posted23 Jan 2023
- Study start31 Jan 2023
- Primary completion15 May 2024 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis 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
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canary Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693818
- Sponsor's protocol ID
- POS-CTE-003
- Status last verified
- Sep 2023
- First submitted
- 12 Jan 2023
- 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 Study of Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension
- ClinicalTrials.gov ID
- NCT05693818
- Acronym / sponsor ID
- POS-CTE-003
- Conditions
- Arthritis Knee
- Keywords
- total knee arthroplasty, PersonaIQ
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Canary MedicalIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 23 Jan 2023 (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 objective of this prospective study is to demonstrate accuracy of a limp detection model using a healthcare provider assessment as the non-reference standard.
Detailed description
The primary endpoint of the study is limp severity at the 4-6 week office visit. At 4-6 weeks (+/- 3 days) post-surgery, the healthcare team will assess the patient's limp severity by visual observation on a 3-point Likert scale (0=No limp, 1=Mild/Moderate or 2=Severe).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PersonaIQ | – | Other: Clinical Limping EvalutionPatients indicated for a PersonaIQ total knee arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients indicated for a commercially available PIQ TKA implant who meet the inclusion and exclusion criteria.
Key inclusion criteria (5 listed)
- • Patient must be 18 years of age or older
Key exclusion criteria (9 listed)
- • Simultaneous bilateral TKA
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 |
|---|---|---|
| Clinical Limping EvalutionAlso: Limp DetectionPatients will be asked to perform a Clinical Limping Evaluation in the clinic during their post-operative follow-up visit. This will be performed in a controlled environment within the physician's clinic. Each patient will be asked to walk at their normal walking speed down a hallway for at least 7 consecutive steps and back toward the physician. Walking down the hallway and back is one walking trial. Each patient will be asked to perform 2 walking trials. The health care provider will assess the patient's limp using a 3-point Likert scale (0=No limp, 1=mild/moderate limp, 2=severe limp). If required, patients may use an assistive device and the type of device should be documented. If a patient requires assistance, only the minimum amount of assistance required for a patient to complete the task should be provided. | Other | PersonaIQ |
Primary outcome
Limp Severity
Time frame: 4-6 wks+3 days weeks post TKA
The primary endpoint of the study is limp severity at the 4-6 week office visit. At 4-6 weeks (+/- 3 days) post-surgery, the healthcare team will assess the patient's limp severity by visual observation on a 3-point Likert scale (0=No limp, 1=Mild/Moderate or 2=Severe).
7 secondary outcomes
Test-retest reliability of the Canary Medical Limping Model (CMLM) score
Time frame: 4-6 wks+3 days weeks post TKA
Positive Percent Agreement (PPA) of the CMLM with the healthcare team's assessment
Time frame: 4-6 wks+3 days weeks post TKA
Negative Percent Agreement (NPA) of the CMLM with the healthcare team's assessment
Time frame: 4-6 wks+3 days weeks post TKA
Knee Range of Motion
Time frame: 4-6 wks+3 days weeks post TKA
Numeric Pain Rating Scale
Time frame: 4-6 wks+3 days weeks post TKA
KOOS Jr
Time frame: 4-6 wks+3 days weeks post TKA
Limping Self Evaluation
Time frame: 4-6 wks+3 days weeks post TKA
Results and safety
Results are not available in the source record.
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.
Nora York contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis Knee, run by Canary Medical at 1 site 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 9 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: status not confirmed, 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 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Derek E. Coulter (18066816979, dcoulter@canarymedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limp Severity (time frame: 4-6 wks+3 days weeks post TKA). 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.