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

Physical Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05789784
• Other study ID #: 23-09443-FB
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: April 2024
• Source: Campbell Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: March 31, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Physical Therapy
• Reverse Total Shoulder Arthroplasty

Intervention

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

Locations

Country	Name	City	State
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Campbell Clinic	Germantown	Tennessee
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania
United States	Cleveland Clinic	Weston	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Campbell Clinic	American Shoulder and Elbow Surgeons

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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