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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05789784




Registration number
NCT05789784
Ethics application status
Date submitted
16/03/2023
Date registered
29/03/2023

Titles & IDs
Public title
Study of Zimmer Biomet Mymobility Application on Reverse Total Shoulder Arthroplasty (RTSA) Outcomes
Scientific title
Multicenter Prospective Study of Zimmer Biomet Mymobility Application on Reverse Total Shoulder Arthroplasty (RTSA) Outcomes
Secondary ID [1] 0 0
23-09443-FB
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reverse Total Shoulder Arthroplasty 0 0
Physical Therapy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - mymobility Physical Therapy
Other interventions - Standard Office-based Physical Therapy

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.

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.


Other interventions: mymobility Physical Therapy
Physical therapy protocol administered at home through the mymobility application.

Other interventions: Standard Office-based Physical Therapy
Physical Therapy protocol administered through exercise handouts and formal office-based therapy directed by physical therapist.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Score
Timepoint [1] 0 0
6 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee

Funding & Sponsors
Primary sponsor type
Other
Name
Campbell Clinic
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
American Shoulder and Elbow Surgeons
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tyler J Brolin, MD
Address 0 0
Campbell Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05789784