Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension

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.

Study Overview

• Status: Recruiting
• Conditions: Arthritis Knee
• Intervention / Treatment: Other: Clinical Limping Evalution

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 Type: Observational
• Enrollment (Estimated): 88

Contacts and Locations

• Study Contact: Name: Derek E. Coulter; Phone Number: 18066816979; Email: dcoulter@canarymedical.com
• Study Contact Backup: Name: Nora York; Email: nyork@canarymedical.com

Study Locations

• United States
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Recruiting
      • Carolina Orthopaedic & Neurosurgical Associates
      • Contact: Daniel Gerscovich, MD; Phone Number: 864-582-6396
      • Principal Investigator: Daniel Gerscovich, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients indicated for a commercially available PIQ TKA implant who meet the inclusion and exclusion criteria.

Description

Inclusion Criteria:

• • 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

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 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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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: Limp Detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	4-6 wks+3 days weeks post TKA

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	4-6 wks+3 days weeks post TKA
Knee Range of Motion	ROM will be measured by a goniometer	4-6 wks+3 days weeks post TKA
Numeric Pain Rating Scale	Subjective Pain Measurement	4-6 wks+3 days weeks post TKA
KOOS Jr	Patient Reported outcome	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	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)	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)	4-6 wks+3 days weeks post TKA

Collaborators and Investigators

• Sponsor: Canary Medical

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2023
• Primary Completion (Estimated): May 15, 2024
• Study Completion (Estimated): May 15, 2024

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: total knee arthroplasty; PersonaIQ
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: POS-CTE-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes