NCT06863428

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Nov 2025Jul 2026

First Submitted

Initial submission to the registry

March 3, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

November 21, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

January 20, 2026

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

March 3, 2025

Last Update Submit

January 15, 2026

Conditions

Knee Range of Motion

Keywords

mymobilityrange of motiongoniometer

Outcome Measures

Primary Outcomes (3)

  • 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)

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Advanced Orthopedics and Sports Medicine

Auburn Hills, Michigan, 48326, United States

RECRUITING

Study Officials

  • Hillary Overholser

    Zimmer Biomet

    STUDY DIRECTOR

Central Study Contacts

Erik Kowalski, PhD

CONTACT

16473316652erik.kowalski@zimmerbiomet.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2025

First Posted

March 7, 2025

Study Start

November 21, 2025

Primary Completion

February 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

January 20, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)