Trials / Enrolling By Invitation
Enrolling By InvitationNCT05789784
Study of Zimmer Biomet Mymobility Application on Reverse Total Shoulder Arthroplasty (RTSA) Outcomes
Multicenter Prospective Study of Zimmer Biomet Mymobility Application on Reverse Total Shoulder Arthroplasty (RTSA) Outcomes
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Campbell Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This is a prospective, multicenter, randomized controlled trial comparing a self-directed rehabilitation protocol using the Zimmer Biomet mymobility digital platform versus standard office based physical therapy protocol after reverse total shoulder arthroplasty. Subjects will be randomly assigned to the Treatment Cohort (mymobility Physical Therapy) or the Control Cohort (Standard Office-based Physical Therapy). Randomization will occur following completion of a signed consent form. Each Participating Site will receive sealed, numbered randomization envelopes from the Lead Site. The treatment cohort is mymobility PT. If the subject is randomized to this cohort, the Participating Site will assist the subject to download the mymobility mobile application (app) during the preoperative visit. The app has a video of each of the exercises to be completed per phase of the rehabilitation protocol beginning on postop day one. The control cohort is Standard office PT. Home exercises begin on postoperative day one with office visits beginning after the 2 week postoperative visit. Subject data will be collected through the 6-month postoperative visit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | mymobility Physical Therapy | Physical therapy protocol administered at home through the mymobility application. |
| OTHER | Standard Office-based Physical Therapy | Physical Therapy protocol administered through exercise handouts and formal office-based therapy directed by physical therapist. |
Timeline
- Start date
- 2023-10-31
- Primary completion
- 2026-09-01
- Completion
- 2027-03-31
- First posted
- 2023-03-29
- Last updated
- 2026-01-05
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05789784. Inclusion in this directory is not an endorsement.