Mymobility Knee ROM

Concordance Between an App-based Range of Motion Measurement and Standard Goniometer.

This prospective study aims to evaluate the agreement, also referred as concordance, of the mymobilty knee ROM with a clinician's assessment of knee ROM via goniometer.

Study Overview

• Status: Recruiting
• Conditions: Knee Range of Motion

• Study Type: Observational
• Enrollment (Estimated): 41

Contacts and Locations

• Study Contact: Name: Erik Kowalski, PhD; Phone Number: 16473316652; Email: erik.kowalski@zimmerbiomet.com

Study Locations

• United States
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Recruiting
      • Center for Advanced Orthopedics and Sports Medicine
      • Principal Investigator: Nicholas Frisch, MD
      • Contact: Garett Smith; Phone Number: 248-377-8000; Email: gsmith@centerforao.com
      • Contact: Email: nick@frischortho.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of a minimum of 41 patients who meet all the inclusion criteria and none of the exclusion criteria.

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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / 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

Outcome Measure	Measure Description	Time Frame
Active knee flexion	Patients will be asked to sit in a chair to measure full active knee flexion.	Day 1 (Single Visit)
Active knee extension	Patients will be asked to sit in a chair to measure full active knee extension.	Day 1 (Single Visit)
Passive knee extension with overpressure	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: Zimmer Biomet
• Investigators: Study Director: Hillary Overholser, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 7, 2025

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: range of motion; goniometer; mymobility
• Other Study ID Numbers: CSU2024-28TDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No