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

NCT05789784 | Enrolling By Invitation

• 1 other identifier: 23-09443-FB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Reverse Total Shoulder Arthroplasty; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Score

  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.

  6 months

Study Arms (2)

mymobility Physical Therapy

EXPERIMENTAL

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

Standard Office-based Physical Therapy

ACTIVE COMPARATOR

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

Interventions

Standard Office-based Physical Therapy OTHER

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

Standard Office-based Physical Therapy

mymobility Physical Therapy OTHER

Physical therapy protocol administered at home through the mymobility application.

mymobility Physical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Campbell Clinic: lead
• American Shoulder and Elbow Surgeons: collaborator

Study Sites (4)

Atlantis Orthopedics

Palm Beach Gardens, Florida, 33410, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43202, United States

Location

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Campbell Clinic

Germantown, Tennessee, 38138, United States

Location

Related Publications (6)

• Wagner ER, Farley KX, Higgins I, Wilson JM, Daly CA, Gottschalk MB. The incidence of shoulder arthroplasty: rise and future projections compared with hip and knee arthroplasty. J Shoulder Elbow Surg. 2020 Dec;29(12):2601-2609. doi: 10.1016/j.jse.2020.03.049. Epub 2020 Jun 9.

  PMID: 33190759 BACKGROUND

• Crawford DA, Lombardi AV Jr, Berend KR, Huddleston JI 3rd, Peters CL, DeHaan A, Zimmerman EK, Duwelius PJ. Early outcomes of primary total hip arthroplasty with use of a smartphone-based care platform: a prospective randomized controlled trial. Bone Joint J. 2021 Jul;103-B(7 Supple B):91-97. doi: 10.1302/0301-620X.103B7.BJJ-2020-2402.R1.

  PMID: 34192907 BACKGROUND

• Crawford DA, Duwelius PJ, Sneller MA, Morris MJ, Hurst JM, Berend KR, Lombardi AV. 2021 Mark Coventry Award: Use of a smartphone-based care platform after primary partial and total knee arthroplasty: a prospective randomized controlled trial. Bone Joint J. 2021 Jun;103-B(6 Supple A):3-12. doi: 10.1302/0301-620X.103B6.BJJ-2020-2352.R1.

  PMID: 34053272 BACKGROUND

• Yayac M, Moltz R, Pivec R, Lonner JH, Courtney PM, Austin MS. Formal Physical Therapy Following Total Hip and Knee Arthroplasty Incurs Additional Cost Without Improving Outcomes. J Arthroplasty. 2020 Oct;35(10):2779-2785. doi: 10.1016/j.arth.2020.04.023. Epub 2020 Apr 18.

  PMID: 32674941 BACKGROUND

• Simovitch RW, Friedman RJ, Cheung EV, Flurin PH, Wright T, Zuckerman JD, Roche C. Rate of Improvement in Clinical Outcomes with Anatomic and Reverse Total Shoulder Arthroplasty. J Bone Joint Surg Am. 2017 Nov 1;99(21):1801-1811. doi: 10.2106/JBJS.16.01387.

  PMID: 29088034 BACKGROUND

• Kolin DA, Moverman MA, Pagani NR, Puzzitiello RN, Dubin J, Menendez ME, Jawa A, Kirsch JM. Substantial Inconsistency and Variability Exists Among Minimum Clinically Important Differences for Shoulder Arthroplasty Outcomes: A Systematic Review. Clin Orthop Relat Res. 2022 Jul 1;480(7):1371-1383. doi: 10.1097/CORR.0000000000002164. Epub 2022 Mar 17.

  PMID: 35302970 BACKGROUND

Study Officials

• Tyler J Brolin, MD

  Campbell Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Shoulder and Elbow Surgery, Co-director Shoulder and Sports Medicine Fellowship

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: October 31, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)