RECRUITING

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

Conditions

Arthritis Knee total knee arthroplasty PersonaIQ

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Multicenter, Single- Arm Study of Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension

Quick Facts

Study Start:2023-01-31

Study Completion:2024-05-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05693818

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* • 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

Inclusion Criteria

Exclusion 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

* • 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

Contacts and Locations

Study Contact

Derek E. Coulter

CONTACT

18066816979

dcoulter@canarymedical.com

Nora York

CONTACT

nyork@canarymedical.com

Study Locations (Sites)

Carolina Orthopaedic & Neurosurgical Associates

Spartanburg, South Carolina, 29303

United States

Collaborators and Investigators

Sponsor: Canary Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-31

Study Completion Date2024-05-15

Study Record Updates

Study Start Date2023-01-31

Study Completion Date2024-05-15

Terms related to this study

Keywords Provided by Researchers

total knee arthroplasty
PersonaIQ

Additional Relevant MeSH Terms

Arthritis Knee