Study of Zimmer Biomet Mymobility Application on Reverse Total Shoulder Arthroplasty (RTSA) Outcomes
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ClinicalTrials.gov Identifier: NCT05789784 |
Recruitment Status :
Enrolling by invitation
First Posted : March 29, 2023
Last Update Posted : May 1, 2024
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Condition or disease | Intervention/treatment | Phase |
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Reverse Total Shoulder Arthroplasty Physical Therapy | Other: mymobility Physical Therapy Other: Standard Office-based Physical Therapy | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated 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 |
Actual Study Start Date : | October 31, 2023 |
Estimated Primary Completion Date : | September 1, 2025 |
Estimated Study Completion Date : | March 31, 2026 |
Arm | Intervention/treatment |
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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.
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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.
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Other: Standard Office-based Physical Therapy
Physical Therapy protocol administered through exercise handouts and formal office-based therapy directed by physical therapist. |
- 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05789784
United States, Florida | |
Cleveland Clinic | |
Weston, Florida, United States, 33331 | |
United States, Ohio | |
Ohio State University Medical Center | |
Columbus, Ohio, United States, 43202 | |
United States, Pennsylvania | |
Rothman Orthopaedic Institute | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Tennessee | |
Campbell Clinic | |
Germantown, Tennessee, United States, 38138 |
Principal Investigator: | Tyler J Brolin, MD | Campbell Clinic |
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: |
23-09443-FB |
First Posted: | March 29, 2023 Key Record Dates |
Last Update Posted: | May 1, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |