Reverse Total Shoulder ArthroplastyNCT05789784
Study of Zimmer Biomet Mymobility Application on Reverse Total Shoulder Arthroplasty (RTSA) Outcomes
A study testing mymobility Physical Therapy and Standard Office-based Physical Therapy in people with Reverse Total Shoulder Arthroplasty and Physical Therapy, run by Campbell Clinic at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reverse Total Shoulder Arthroplasty, Physical Therapy
- What is being tested?
- mymobility Physical Therapy and Standard Office-based Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 31 Oct 2023to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Ohio State University Medical Center
Columbus, Ohio, 43202
Campbell Clinic
Germantown, Tennessee, 38138
Atlantis Orthopedics
Palm Beach Gardens, Florida, 33410
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Multicenter Prospective 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.
Read the 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.
- Being tested
- mymobility Physical Therapy, Standard Office-based Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mymobility Physical TherapyOther
Physical therapy protocol administered at home through the mymobility application.
Standard Office-based Physical TherapyOther
Physical Therapy protocol administered through exercise handouts and formal office-based therapy directed by physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Office-based Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start31 Oct 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Reverse Total Shoulder ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campbell Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- American Shoulder and Elbow Surgeons
- Responsible party
- Principal investigator, Tyler J. Brolin, Campbell Clinic
- Investigators
- Tyler J Brolin, MD, Principal investigator, Campbell Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789784
- Sponsor's protocol ID
- 23-09443-FB
- Status last verified
- Dec 2025
- First submitted
- 16 Mar 2023
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33190759Crawford 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.
PubMed 34192907Crawford 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.
PubMed 34053272Yayac 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.
PubMed 32674941Simovitch 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.
PubMed 29088034Kolin 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.
PubMed 35302970
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Study of Zimmer Biomet Mymobility Application on Reverse Total Shoulder Arthroplasty (RTSA) Outcomes
- ClinicalTrials.gov ID
- NCT05789784
- Acronym / sponsor ID
- 23-09443-FB
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Campbell ClinicUniversity, hospital or other
- Collaborators
- American Shoulder and Elbow Surgeons
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mymobility Physical Therapy | Experimental | Other: mymobility Physical TherapyThe 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 | Active comparator | Other: Standard Office-based Physical TherapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mymobility Physical TherapyPhysical therapy protocol administered at home through the mymobility application. | Other | mymobility Physical Therapy |
| Standard Office-based Physical TherapyPhysical Therapy protocol administered through exercise handouts and formal office-based therapy directed by physical therapist. | Other | Standard Office-based Physical Therapy |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Background: PubMed 33190759Wagner 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.
- Background: PubMed 34192907Crawford 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.
- Background: PubMed 34053272Crawford 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.
- Background: PubMed 32674941Yayac 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.
- Background: PubMed 29088034Simovitch 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.
- Background: PubMed 35302970Kolin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tyler J Brolin, MD principal investigator
Campbell Clinic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mymobility Physical Therapy and Standard Office-based Physical Therapy in people with Reverse Total Shoulder Arthroplasty and Physical Therapy, run by Campbell Clinic at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05789784, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.