Study of Zimmer Biomet Mymobility Application on Reverse Total Shoulder Arthroplasty (RTSA) Outcomes

Not Applicable

• Conditions: Reverse Total Shoulder Arthroplasty; Physical Therapy
• Interventions: Other: mymobility Physical Therapy; Other: Standard Office-based Physical Therapy

• Registration Number: NCT05789784
• Lead Sponsor: Campbell Clinic

Brief 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.

Study Timeline

• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-03-16
• Study First Posted: 2023-03-29
• Study Start: 2023-10-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-09-01
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 18 years of age or older.
• Primary Reverse Total Shoulder Arthroplasty performed for diagnosis of cuff tear arthropathy (CTA), massive rotator cuff tears (mRCT), osteoarthritis (OA), or inflammatory arthritis (IA).
• Have a functioning smartphone model compatible with the mymobility platform.

Exclusion Criteria

• Less than 18 years of age.
• Revision Reverse Total Shoulder Arthroplasty
• Concomitant tendon transfer
• Planned discharge to inpatient rehab facility, skilled nursing home, or use of home health therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mymobility Physical Therapy	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.
Standard Office-based Physical Therapy	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 Measures

Name	Time	Method
American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Score	6 months	The ASES Standardized Shoulder Assessment Score outputs a measurement of patient pain and function on a scale of 0 to 100, with 0 being the greatest pain and no function and 100 being no pain and perfect function.

Trial Locations

Locations (4)

Atlantis Orthopedics; 🇺🇸 Palm Beach Gardens, Florida, United States

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States

Campbell Clinic; 🇺🇸 Germantown, Tennessee, United States