Clinical trial NCT05693818: Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension
Official title: A Multicenter, Single- Arm Study of Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthritis Knee
Keywords: total knee arthroplasty
PersonaIQ
Lead sponsor: Canary Medical
Sponsor class: INDUSTRY
First posted: 2023-01-23
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients indicated for a commercially available PIQ TKA implant who meet the inclusion and exclusion criteria.

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.

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).

Eligibility 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

Primary outcomes:
measure: Limp Severity
timeFrame: 4-6 wks+3 days weeks post TKA
Secondary outcomes:
measure: Test-retest reliability of the Canary Medical Limping Model (CMLM) score
timeFrame: 4-6 wks+3 days weeks post TKA
measure: Positive Percent Agreement (PPA) of the CMLM with the healthcare team's assessment
timeFrame: 4-6 wks+3 days weeks post TKA
measure: Negative Percent Agreement (NPA) of the CMLM with the healthcare team's assessment
timeFrame: 4-6 wks+3 days weeks post TKA
measure: Knee Range of Motion
timeFrame: 4-6 wks+3 days weeks post TKA
measure: Numeric Pain Rating Scale
timeFrame: 4-6 wks+3 days weeks post TKA
measure: KOOS Jr
timeFrame: 4-6 wks+3 days weeks post TKA
measure: Limping Self Evaluation
timeFrame: 4-6 wks+3 days weeks post TKA
Other outcomes:
Locations:
city: Spartanburg
country: United States
facility: Carolina Orthopaedic & Neurosurgical Associates
state: South Carolina
Study officials:
References: