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

NCT ID: NCT05693818

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 88 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2024-05-15

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).

Conditions

Arthritis Knee

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PersonaIQ

Patients indicated for a PersonaIQ total knee arthroplasty

Clinical Limping Evalution

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Limp Detection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canary Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Carolina Orthopaedic & Neurosurgical Associates

Spartanburg, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Derek E. Coulter

Role: CONTACT

dcoulter@canarymedical.com

18066816979

Nora York

Role: CONTACT

nyork@canarymedical.com

Facility Contacts

Daniel Gerscovich, MD

Role: primary

864-582-6396

Other Identifiers

POS-CTE-003

Identifier Type: -

Identifier Source: org_study_id