Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension
- Conditions
- Arthritis Knee
- Interventions
- Other: Clinical Limping Evalution
- Registration Number
- NCT05693818
- Lead Sponsor
- Canary Medical
- 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.
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 88
-
• 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
-
• 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PersonaIQ Clinical Limping Evalution Patients indicated for a PersonaIQ total knee arthroplasty
- Primary Outcome Measures
Name Time Method 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
Name Time Method Knee Range of Motion 4-6 wks+3 days weeks post TKA ROM will be measured by a goniometer
Positive Percent Agreement (PPA) of the CMLM with the healthcare team's assessment 4-6 wks+3 days weeks post TKA Positive Percent Agreement (PPA)
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 timeTest-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.)
Negative Percent Agreement (NPA) of the CMLM with the healthcare team's assessment 4-6 wks+3 days weeks post TKA Negative Percent Agreement (NPA)
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
Trial Locations
- Locations (1)
Carolina Orthopaedic & Neurosurgical Associates
🇺🇸Spartanburg, South Carolina, United States