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

Canary Medical88 enrolled

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.

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

Conditions

Arthritis Knee

Interventions

Clinical Limping EvalutionOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Carolina Orthopaedic & Neurosurgical Associates

Spartanburg, South Carolina, United States

RECRUITING