Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000640505
Ethics application status
Approved
Date submitted
4/04/2024
Date registered
17/05/2024
Date last updated
17/05/2024
Date data sharing statement initially provided
17/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Minimum 2-year follow up of a reverse total shoulder arthroplasty using a wedged baseplate in patients aged 90 or less
Scientific title
Minimum 2-year follow up of a reverse total shoulder arthroplasty using a wedged baseplate in patients aged 90 or less
Secondary ID [1] 311948 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder cuff arthropathy and arthritis 333408 0
Rotator cuff arthropathy, osteoarthritis and rheumatoid arthritis 333409 0
Condition category
Condition code
Musculoskeletal 330089 330089 0 0
Other muscular and skeletal disorders
Surgery 330223 330223 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Reverse shoulder prosthesis with wedged baseplate
Surgical insertion of a reverse shoulder prosthesis with a wedged baseplate
Surgery performed by Trained orthopaedic shoulder surgeons under general anaesthesia.
Surgical time 2 hours.
Blood loss 200 mls.
The prosthesis is permanent.
Prosthesis numbers held in Medical records of the hospital involved. Detail of operative procedure held in patient notes.
The surgery performed in the Operating theatres of Cabrini Private Hospital Brighton, and Linacre Private Hospital Hampton .Victoria.
Clinical examination, Patient Reported Outcome Measures (PROMS): American Shoulder and Elbow Score (ASES). , Constant Score, Disability of the Arm, Shoulder and Hand (DASH), Shoulder Pain and Disability Score (SPADI), Visual Analogue Score for pain (VAS), satisfaction with operation and imaging at 2 weeks, 6 weeks, 3 months 12 months, 24 months (primary endpoint) post surgical operation, and then imaging, VAS, SPADI, Satisfaction and annually for 10 years..
Intervention code [1] 328321 0
Treatment: Surgery
Comparator / control treatment
No control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337843 0
Change in pain severity
Timepoint [1] 337843 0
2 weeks, 6 weeks, 12 weeks, 12 months, 24 months (primary endpoint) and thereafter annually for 10 years post surgery.
Secondary outcome [1] 433445 0
Change in range of movement
Timepoint [1] 433445 0
This will be assessed as a composite measure at 3 months, year 1 and year 2 following surgery..
Secondary outcome [2] 434556 0
Gleno -humeral radiolucent lines, notching and osteolysis. This will be assessed as a composite measure
Timepoint [2] 434556 0
24 Hours, 3 months, 12 months 24 months and annually for 10 years thereafter following surgery
Secondary outcome [3] 434557 0
Satisfaction with operation
Timepoint [3] 434557 0
Annually 10 years from operation
Secondary outcome [4] 434889 0
Shoulder Pain and Disability Disability Index (SPADI)
Timepoint [4] 434889 0
Annually from operation for 10 years following surgery.

Eligibility
Key inclusion criteria
• Age 18 to 90 years
• Primary glenohumeral osteoarthritis
• Previous shoulder surgery
• Cuff tear arthropathy
• Massive rotator cuff tear
• Post traumatic arthritis
• Instability arthropathy
• Avascular necrosis
• Rheumatoid arthritis
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Abnormal neurology
• Mental inability to comply with rehabilitation
• Glenoid Walch C
• Revision surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
22/03/2018
Date of last participant enrolment
Anticipated
Actual
15/07/2021
Date of last data collection
Anticipated
15/01/2027
Actual
Sample size
Target
70
Accrual to date
Final
73
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316204 0
Commercial sector/Industry
Name [1] 316204 0
Stryker
Country [1] 316204 0
Australia
Primary sponsor type
Individual
Name
A/Professor Simon Bell
Address
Country
Australia
Secondary sponsor category [1] 318388 0
None
Name [1] 318388 0
Address [1] 318388 0
Country [1] 318388 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315021 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 315021 0
https://www.monash.edu/researchoffice/ethics
Ethics committee country [1] 315021 0
Australia
Date submitted for ethics approval [1] 315021 0
08/10/2013
Approval date [1] 315021 0
29/10/2013
Ethics approval number [1] 315021 0

Summary
Brief summary
Surgical insertion of a reversed total shoulder replacement in patients with arthritis and torn muscles and tendons. The use of a wedged base plate in reverse shoulder replacement allows easier positioning of the socket part of the shoulder joint and less removal of bone .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133450 0
A/Prof Simon Bell
Address 133450 0
Melbourne Shoulder and Elbow Centre , Suite 1, 80 Beach Rd. Sandringham Victoria 3191
Country 133450 0
Australia
Phone 133450 0
+61395928028
Fax 133450 0
Email 133450 0
[email protected]
Contact person for public queries
Name 133451 0
Dr.Jennifer Coghlan
Address 133451 0
Melbourne Shoulder and Elbow Centre Research Dept., (Monash University) Suite 1, 80 Beach Rd. Sandringham Victoria 3191
Country 133451 0
Australia
Phone 133451 0
+6103 95928028
Fax 133451 0
Email 133451 0
[email protected]
Contact person for scientific queries
Name 133452 0
A/Professor Simon Bell
Address 133452 0
Melbourne Shoulder and Elbow Centre , Suite 1, 80 Beach Rd. Sandringham Victoria 3191
Country 133452 0
Australia
Phone 133452 0
+61395928028
Fax 133452 0
Email 133452 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.