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Enrolling by Invitation

NCT Number: NCT05789784

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

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.

Enrolling by Invitation

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Key information

Conditions

Reverse Total Shoulder Arthroplasty Physical Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlantis Orthopedics, Palm Beach Gardens, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Campbell Clinic

Other

Collaborators

  • American Shoulder and Elbow Surgeons

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Mar 29, 2023
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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