NCT05693818

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 88 (estimated)
• Sponsor: Canary Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Arthritis Knee

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-31
• Primary completion: 2024-05-15
• Completion: 2024-05-15
• First posted: 2023-01-23
• Last updated: 2023-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study