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NCT05693818 | RECRUITING | Arthritis Knee

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

Canary Medical

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.

Condition or disease

Arthritis Knee

Intervention/treatment

Clinical Limping Evalution

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).

Study Type : OBSERVATIONAL
Estimated Enrollment : 88 participants
Official Title : A Multicenter, Single- Arm Study of Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension
Actual Study Start Date : 2023-01-31
Estimated Primary Completion Date : 2024-05-15
Estimated Study Completion Date : 2024-05-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension

Location Details

NCT05693818

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, South Carolina

Carolina Orthopaedic & Neurosurgical Associates

Spartanburg, South Carolina, United States, 29303