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

NCT05693818 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 88

Last updated 2023-09-21

No results posted yet for this study

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.

Conditions

  • Arthritis Knee

Interventions

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.

Sponsors & Collaborators

  • Canary Medical

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2024-05-15
Completion
2024-05-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05693818 on ClinicalTrials.gov