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

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.

Conditions

Arthritis Knee

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Arthritis Knee
Intervention / Treatment

-

Contacts and Locations

Spartanburg

Carolina Orthopaedic & Neurosurgical Associates, Spartanburg, South Carolina, United States, 29303

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Canary Medical,

Study Record Dates

2024-05-15