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

NCT05693818 | Unknown FDA Device

• 1 other identifier: POS-CTE-003
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis Knee

Keywords

total knee arthroplasty; PersonaIQ

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Test-retest reliability of the Canary Medical Limping Model (CMLM) score

  4-6 wks+3 days weeks post TKA

• 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

• Numeric Pain Rating Scale

  4-6 wks+3 days weeks post TKA

Study Arms (1)

PersonaIQ

Patients indicated for a PersonaIQ total knee arthroplasty

Other: Clinical Limping Evalution

Interventions

Clinical Limping Evalution OTHER

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.

Also known as: Limp Detection

PersonaIQ

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Canary Medical: lead

Study Sites (1)

Carolina Orthopaedic & Neurosurgical Associates

Spartanburg, South Carolina, 29303, United States

RECRUITING

Central Study Contacts

Derek E. Coulter

CONTACT

18066816979; dcoulter@canarymedical.com

Nora York

CONTACT

nyork@canarymedical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 23, 2023
• Study Start: January 31, 2023
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

US (1)