A Prospective Multicenter Longitudinal Cohort Study of the mymobility Platform

Completed

• Conditions: joint replacement; osteoarthritis; 10023213

• Registration Number: NL-OMON54833
• Lead Sponsor: Zimmer Biomet Nederland bv

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

• Subject must be 18 years of age or older.
• Subject is indicated for a primary, unilateral total or partial knee
arthroplasty, or total hip arthroplasty based on a physical exam.
• Investigator plans to treat subject with a Zimmer Biomet device as part of
their clinical care.
• Subject must own and maintain an iPhone 6 or newer (excluding the iPhone SE).
• Subject is mobile with no more than a single cane/single crutch assist.

Exclusion Criteria

• Subject is a current alcohol or drug abuser. • Subject has inflammatory
arthropathies which would interfere or compromise the activity profiles within
this study. • Subject is considered a member of a protected population (e.g.,
prisoner, mentally incompetent, etc.). • Subject is currently participating in
any other surgical intervention, physical therapy or pain management study
which would compromise the results of this study. • Subject requires
simultaneous or staged bilateral replacements, staged <90 days apart.
Subjects can be enrolled into the study for the second, staged arthroplasty if
scheduled >89 days after their first, contralateral replacement.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint: Non-inferior results between the current SOC and the<br /><br>mymobility platform for all-cause 30-day readmission rates.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include KOOS, JR. (Knee); HOOS, JR. (Hip), manipulation<br /><br>under anesthesia (knee), single leg stance test, timed up and go (TUG),<br /><br>satisfaction for those subjects who complete the mymobility program compared to<br /><br>those who complete traditional, standard of care education and rehabilitation. </p><br>