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

Sponsor

Campbell Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05789784

Collaborator

American Shoulder and Elbow Surgeons (Other)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Reverse Total Shoulder Arthroplasty Physical Therapy	Other: mymobility Physical Therapy Other: Standard Office-based Physical Therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: mymobility Physical Therapy Physical therapy protocol administered at home through the mymobility application.
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.	Other: Standard Office-based Physical Therapy Physical Therapy protocol administered through exercise handouts and formal office-based therapy directed by physical therapist.

Arm

Intervention/Treatment

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.

Other: mymobility Physical Therapy

Physical therapy protocol administered at home through the mymobility application.

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.

Other: Standard Office-based Physical Therapy

Physical Therapy protocol administered through exercise handouts and formal office-based therapy directed by physical therapist.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Campbell Clinic
American Shoulder and Elbow Surgeons

Investigators

Principal Investigator: Tyler J Brolin, MD, Campbell Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Tyler J. Brolin, Assistant Professor, Shoulder and Elbow Surgery, Co-director Shoulder and Sports Medicine Fellowship, Campbell Clinic

ClinicalTrials.gov Identifier:

NCT05789784

Other Study ID Numbers:

Version 1.2

First Posted:

Mar 29, 2023

Last Update Posted:

Mar 29, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 29, 2023