A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform (NCT03737149) | Clinical Trial Compass
CompletedNot Applicable
A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
United States6,559 participantsStarted 2018-10-22
Plain-language summary
Post-market prospective, multi-center longitudinal study to determine if mobile application-guided education and exercise paired with accurate and sensitive activity monitoring, captured from consumer wearables, can provide a viable (and potentially improved) alternative to current standard of care physical therapy for hip and knee arthroplasty.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject must be 18 years of age or older.
✓. Subject qualifies for a primary, unilateral total or partial knee arthroplasty, based on physical exam and medical history.
✓. Investigator plans to treat subject with a commercially-available device, used on-label according to the manufacturer's instructions for use, as part of their clinical care.
✓. Subject owns and maintains an iPhone capable of pairing to the Apple Watch, supporting iOS updates and is compatible with the mymobility App.
✓. Subject is willing and able to complete the protocol required follow-up.
✓. Subject is able to read and understand the language used in the mymobility App for their region.
✓. Subject is willing and able to provide written Informed Consent and Authorization by signing and dating the IRB/EC approved Informed Consent Form and Authorization. Where applicable, subject must also be willing to provide authorization for use of protected health information in accordance with local privacy laws.
✓. Subject is mobile with no more than a single cane/single crutch assist preoperatively.
Exclusion criteria
✕. Subject is a current alcohol or drug abuser as defined by the investigator.
✕. Subject is considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).
. Subject has systemic inflammatory arthropathies which would interfere or compromise the activity profiles within this study.
✕. 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.