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 — OTHER
    Physical therapy protocol administered at home through the mymobility application.
  • Standard Office-based Physical Therapy — OTHER
    Physical 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 Therapy
    The 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 Therapy
    The 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)

FacilityCityStateZIPSite coordinators
Atlantis OrthopedicsPalm Beach GardensFlorida33410-
Ohio State University Medical CenterColumbusOhio43202-
Rothman Orthopaedic InstitutePhiladelphiaPennsylvania19107-
Campbell ClinicGermantownTennessee38138-

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