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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04864158




Registration number
NCT04864158
Ethics application status
Date submitted
13/04/2021
Date registered
28/04/2021

Titles & IDs
Public title
Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy
Scientific title
Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy Eligible For Reverse Shoulder Arthroplasty: the ReAct Multicenter, Randomized Controlled Trial
Secondary ID [1] 0 0
REACT
Universal Trial Number (UTN)
Trial acronym
REACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator Cuff Arthropathy 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - TSA-group
Other interventions - Exercise-group

Experimental: RSA-group - Surgery

Experimental: Exercise-group - Exercise


Treatment: Surgery: TSA-group
Reverse total shoulder arthroplasty followed by standard rehabilitation.

Other interventions: Exercise-group
The exercise-group will attend a 12-week exercise program with one weekly physiotherapist-supervised session supplemented with two weekly sessions of home-based exercises. Utilisation of a predefined training protocol describing procedures and content of each session secure uniformity and standardisation of the intervention. The exercise program consists of two warm-up exercises and five exercises that target shoulder range of motion and muscle strength. Furthermore, a link to a video, informing about glenohumeral osteoarthritis, the role of exercise and exercise related pain, will be sent to all patients in the exercise-group. The physiotherapists delivering the exercise intervention are not otherwise related to the trial.
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
the Western Ontario Osteoarthritis of the Shoulder index (WOOS)
Timepoint [1] 0 0
Measured at 12 month follow-up
Secondary outcome [1] 0 0
the Western Ontario Osteoarthritis of the Shoulder index (WOOS)
Timepoint [1] 0 0
Measured at baseline, 12-week, 2-, 5- and 10-year follow-up
Secondary outcome [2] 0 0
Disabilities of the Arm, Shoulder and Hand (DASH)
Timepoint [2] 0 0
Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
Secondary outcome [3] 0 0
The change in pain measured on a 100 mm Visual Analogue Scale (VAS)
Timepoint [3] 0 0
Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
Secondary outcome [4] 0 0
The use of analgesics during the last week
Timepoint [4] 0 0
Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
Secondary outcome [5] 0 0
The type of analgesics consumed during the last week
Timepoint [5] 0 0
Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
Secondary outcome [6] 0 0
Consumption of analgesics during the last week
Timepoint [6] 0 0
Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
Secondary outcome [7] 0 0
Serious Adverse Events
Timepoint [7] 0 0
The patients in the surgical intervention group will be monitored for serious adverse events during the 4 weeks from the discharge.
Secondary outcome [8] 0 0
Adverse events
Timepoint [8] 0 0
Occurring during the period from inclusion until the 12-month follow-up

Eligibility
Key inclusion criteria
* Patients 60-85 years
* Eligible for RSA
* Rotator cuff arthropathy according to Hamada grade 3, 4 and 5 (33)
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous shoulder fracture (fracture of the proximal humerus or glenoid fracture)
* Planned other upper extremity surgery within six months
* Rheumatoid arthritis or other types of arthritis not diagnosed as primary glenohumeral OA
* Cancer diagnosis and receiving chemo-, immuno- or radiotherapy
* Neurological diseases affecting shoulder mobility (e.g. disability after previous stroke, multiple sclerosis, Parkinson's, Alzheimer's disease)
* Other reasons for exclusion (i.e. mentally unable to participate) or planned absence for more than 14 days in the first 3 months after baseline test.
* Unable to communicate in the participating countries respective languages

Study design
Purpose of the study
Treatment
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
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
28/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2038
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Aarhus N, 8200
Country [2] 0 0
Denmark
State/province [2] 0 0
Esbjerg
Country [3] 0 0
Denmark
State/province [3] 0 0
Farsø
Country [4] 0 0
Denmark
State/province [4] 0 0
Silkeborg
Country [5] 0 0
Denmark
State/province [5] 0 0
Viborg
Country [6] 0 0
Finland
State/province [6] 0 0
Tampere
Country [7] 0 0
Norway
State/province [7] 0 0
Oslo

Funding & Sponsors
Primary sponsor type
Other
Name
University of Aarhus
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Aarhus University Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Tampere University Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Aalborg University Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Regionshospitalet Silkeborg
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Oslo University Hospital
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
The Danish Rheumatism Association
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Association of Danish Physiotherapists
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Regionshospitalet Viborg, Skive
Address [8] 0 0
Country [8] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Josefine B. Larsen, MSc
Address 0 0
Aarhus University Hospital and Aarhus University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Josefine B. Larsen, MSc
Address 0 0
Country 0 0
Phone 0 0
4526237771
Fax 0 0
Email 0 0
josefinebl@clin.au.dk
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pseudo anonymised patient-level data for the primary and all secondary outcome measures will be made available if required by the scientific journal, in which the results of the trial are published.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Analytic code
When will data be available (start and end dates)?
Data will be available after publication of the trial
Available to whom?
Data access will be reviewed by the author group. Requestors will be required to sign a Data Access Agreement.
Available for what types of analyses?
How or where can data be obtained?


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/NCT04864158