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

Canary Medical

Status: Enrolling

Conditions: Arthritis Knee

Treatments: Other: Clinical Limping Evalution

Study type: Observational

Funder types: Industry

Identifiers

NCT05693818

POS-CTE-003

Details and patient eligibility

About

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.

Full 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).

Enrollment: 88 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

88 participants in 1 patient group

PersonaIQ

Description:

Patients indicated for a PersonaIQ total knee arthroplasty

Treatment:

Other: Clinical Limping Evalution