Mymobility Knee ROM
Concordance Between an App-based Range of Motion Measurement and Standard Goniometer.
Study Overview
Status
Status
Conditions
Conditions
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Erik Kowalski, PhD
- Phone Number: 16473316652
- Email: erik.kowalski@zimmerbiomet.com
Study Locations
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Michigan
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Auburn Hills, Michigan, United States, 48326
- Center for Advanced Orthopedics and Sports Medicine
-
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient is a minimum of 18 years of age
- Patient is willing and able to provide written Informed Consent by signing and dating the IRB-approved Informed Consent form
Exclusion Criteria:
- The patient is currently participating in any other study that would hinder the assessor's ability to measure knee ROM
- Complex primary knee pathology with significant restrictions on the range of motion per surgeon discretion
- Patient is pregnant or considered a member of a protected population (e.g. prisoner, mentally incompetent, etc.)
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
|---|
|
Group 1
This group will have their knee range of motion measured three times.
Once with the mymobility app, and twice using a goniometer by two separate assessors.
Each assessor will be blinded to the other assessor's measurements.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Active knee flexion
Time Frame: Day 1 (Single Visit)
|
Patients will be asked to sit in a chair to measure full active knee flexion.
|
Day 1 (Single Visit)
|
|
Active knee extension
Time Frame: Day 1 (Single Visit)
|
Patients will be asked to sit in a chair to measure full active knee extension.
|
Day 1 (Single Visit)
|
|
Passive knee extension with overpressure
Time Frame: Day 1 (Single Visit)
|
Patients will be asked to sit in a chair to measure full passive knee extension while applying overpressure on their knee with their hands.
|
Day 1 (Single Visit)
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Hillary Overholser, Zimmer Biomet
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- CSU2024-28TDS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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