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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

TypeNameDescription
OTHERmymobility Physical TherapyPhysical therapy protocol administered at home through the mymobility application.
OTHERStandard Office-based Physical TherapyPhysical 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.