N/A
N=6,559
A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
Osteoarthritis, Knee · Osteoarthritis, Hip
Bottom Line
View on ClinicalTrials.gov: NCT03737149 ↗Enrolled (actual)
6,559
Serious AEs
4.6%
Results posted
Mar 2026
Primary outcome: Primary: Phase II (RCT): Readmissions — 4; 4; 7; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- mymobility with Apple Watch (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase II (RCT): Readmissions |
4; 4; 7; 1 | — |
| SECONDARY Phase II (RCT): Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS, JR) |
70.0; 73.7 | — |
| SECONDARY Phase II (RCT): Hip Disability and Osteoarthritis Outcome Score - Joint Replacement (HOOS, JR) |
81.8; 83.5 | — |
| SECONDARY Phase II RCT: EQ-5D-5L |
0.8; 0.9; 0.9; 0.9 | — |
| SECONDARY Phase II (RCT): Manipulation Under Anesthesia (MUA) |
5; 10 | — |
| SECONDARY Phase II (RCT): Timed Up and Go (TUG) |
9.3; 10.9; 10.2; 9.7 | — |
| SECONDARY Phase II (RCT): Single-Leg Stance (SLS) Test |
30.8; 28.5; 29.3; 37.3 | — |
| SECONDARY Phase II (RCT): Subject Satisfaction |
29.9; 32.2; 30.3; 33.6 | — |
| SECONDARY Phase II RCT: Urgent Care Center and Emergency Room Visits |
6; 9; 20; 11; 2; 2 | — |
| SECONDARY Phase I (Pilot): Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS, JR) |
73.6 | — |
| SECONDARY Phase I (Pilot): Hip Disability and Osteoarthritis Outcome Score - Joint Replacement (HOOS, JR) |
82.3 | — |
| SECONDARY Phase III (Correlative): Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS, JR) |
71.0 | — |
| SECONDARY Phase III (Correlative): Hip Disability and Osteoarthritis Outcome Score - Joint Replacement (HOOS, JR) |
82.0 | — |
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.
Eligibility Criteria
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 89 days after their first, contralateral replacement.
Data sourced from ClinicalTrials.gov (NCT03737149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.