Study of Zimmer Biomet Mymobility Application on Reverse Total Shoulder Arthroplasty (RTSA) Outcomes
Part of paid clinical trials in Palm Beach Gardens, Florida.
- Sponsor
- Campbell Clinic
- Study ID
- NCT05789784
- Status
- Enrolling By Invitation
Conditions
- Physical Therapy
- Reverse Total Shoulder Arthroplasty
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- mymobility Physical Therapy — OTHERPhysical therapy protocol administered at home through the mymobility application.
- Standard Office-based Physical Therapy — OTHERPhysical Therapy protocol administered through exercise handouts and formal office-based therapy directed by physical therapist.
Study Details
This is a trial comparing self-directed rehabilitation using the Zimmer Biomet mymobility digital platform versus standard office-based physical therapy after reverse shoulder replacement. The investigators hypothesize that there will be no difference in the postoperative outcomes between the mymobility cohort and the standard office-based physical therapy cohort.
Key Dates
- Start date
- Oct 31, 2023
- Status verified
- Dec 2025
- Primary completion
- Sep 1, 2026
- Completion
- Mar 31, 2027
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: mymobility Physical TherapyThe mymobility Physical Therapy cohort will complete an identical protocol to the Standard Office-based Physical Therapy cohort with one exception: the mymobility cohort's therapy for the entire duration of the protocol is administered at home through the mymobility application. This cohort initiates use of the mymobilty application one postoperative day 1. Exercises and restrictions are described in-depth in the Study Protocol document.
- Active Comparator: Standard Office-based Physical TherapyThe Standard Office-based Physical Therapy cohort completes an identical protocol to the mymobility Physical Therapy cohort with one exception: rather than through use of the mymobility application, the Standard Office-based Physical Therapy cohort's protocol is administered through the traditional means of an exercise handout for postoperative day 1 through 2 weeks followed by formal office-based physical therapy for the duration of the protocol. Exercises and restrictions are described in-depth in the Study Protocol document.
Primary Outcome Measure
American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Score [ Time Frame: 6 months ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Atlantis Orthopedics | Palm Beach Gardens | Florida | 33410 | - |
| Ohio State University Medical Center | Columbus | Ohio | 43202 | - |
| Rothman Orthopaedic Institute | Philadelphia | Pennsylvania | 19107 | - |
| Campbell Clinic | Germantown | Tennessee | 38138 | - |
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