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

Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05693818
• Other study ID #: POS-CTE-003
• Status: Recruiting
• Start date: January 31, 2023
• Est. completion date: May 15, 2024

Study information

• Verified date: September 2023
• Source: Canary Medical
• Contact: Derek E. Coulter
• Phone: 18066816979
• Email: dcoulter[@]canarymedical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: May 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis Knee

Intervention

Other:
• Clinical Limping Evalution
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.

Locations

Country	Name	City	State
United States	Carolina Orthopaedic & Neurosurgical Associates	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Canary Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Limp Severity	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).	4-6 wks+3 days weeks post TKA
Secondary	Test-retest reliability of the Canary Medical Limping Model (CMLM) score	Test-retest reliability of the CMLM score from day-to-day and week-to-week. (Specific days and weeks will be provided in the Statistical Analysis Plan.)	4-6 wks+3 days weeks post TKA
Secondary	Positive Percent Agreement (PPA) of the CMLM with the healthcare team's assessment	Positive Percent Agreement (PPA)	4-6 wks+3 days weeks post TKA
Secondary	Negative Percent Agreement (NPA) of the CMLM with the healthcare team's assessment	Negative Percent Agreement (NPA)	4-6 wks+3 days weeks post TKA
Secondary	Knee Range of Motion	ROM will be measured by a goniometer	4-6 wks+3 days weeks post TKA
Secondary	Numeric Pain Rating Scale	Subjective Pain Measurement	4-6 wks+3 days weeks post TKA
Secondary	KOOS Jr	Patient Reported outcome	4-6 wks+3 days weeks post TKA
Secondary	Limping Self Evaluation	Study participants will be asked the following question, "During the past week, have you been limping when walking, because of your knee?" The following answers will be allowed: Rarely / never; Sometimes or just at first, after sitting for a long time; Often, not just at first; Most of the time; All of the time	4-6 wks+3 days weeks post TKA