A Multicenter, Single- Arm Study of Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| PersonaIQ Patients indicated for a PersonaIQ total knee arthroplasty |
Other: Clinical Limping Evalution
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Limp Severity [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).
Secondary Outcome Measures
- Test-retest reliability of the Canary Medical Limping Model (CMLM) score [4-6 wks+3 days weeks post TKA]
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.)
- Positive Percent Agreement (PPA) of the CMLM with the healthcare team's assessment [4-6 wks+3 days weeks post TKA]
- Negative Percent Agreement (NPA) of the CMLM with the healthcare team's assessment [4-6 wks+3 days weeks post TKA]
- Knee Range of Motion [4-6 wks+3 days weeks post TKA]
ROM will be measured by a goniometer
- Numeric Pain Rating Scale [4-6 wks+3 days weeks post TKA]
Subjective Pain Measurement
- KOOS Jr [4-6 wks+3 days weeks post TKA]
Patient Reported outcome
- Limping Self Evaluation [4-6 wks+3 days weeks post TKA]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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• Patient must be 18 years of age or older
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Independent of study participation, patient is indicated for a commercially available PIQ TKA implant in accordance with product labeling
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Patient must be willing and able to complete the protocol required follow-up
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Patient has participated in the study-related informed consent process
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Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved informed consent
Exclusion Criteria:
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• Simultaneous bilateral TKA
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Staged bilateral TKA less than 6 months from indexed procedure
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Patient is a current alcohol or drug abuser
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Patient is known to be pregnant, breastfeeding, or considered a member of a protected class (e.g., prisoner, mentally incompetent, etc.)
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Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent and participation in follow-up program
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Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions
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Patient with Neuropathic Arthropathy
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Patient with any loss of musculature or neuromuscular disease that compromises the affected limb
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Patients with known symptomatic foot, hip or spinal injuries and/or conditions that could affect gait
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Carolina Orthopaedic & Neurosurgical Associates | Spartanburg | South Carolina | United States | 29303 |
Sponsors and Collaborators
- Canary Medical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- POS-CTE-003