Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000795291
Ethics application status
Not required
Date submitted
12/08/2009
Date registered
15/09/2009
Date last updated
18/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
PROMOS - Patient benefit from the new modular shoulder prosthesis
Scientific title
A prospective, multicentre, cohort study evaluating patient benefit after primary total shoulder arthroplasty with the modular PROMOS shoulder system.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative shoulder disease 243412 0
Condition category
Condition code
Musculoskeletal 239713 239713 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PROMOS standard prosthesis- The standard PROMOS features modular components for the metaphyseal part, the collum (modular body) and the humeral head. The body (metaphyseal component) in different heights helps to restore the original length of the humerus und can be fixed in any antetorsion angle.
PROMOS reverse prosthesis - The reverse shoulder system consists of a humeral and a glenoid component, both of which are modular. The humeral stem is used in combination with a body and concave polyethylene component. The concave polyethylene component snaps into the proximal body and articulates with the
hemispherical head attached to the glenoid baseplate. The glenoid baseplate is fixed in the glenoid bone with two screws.

The appropriate treatment type is administered to patients based on individual requirements as determined by the operating surgeon

The duration of the surgical procedure depends on individual circumstances, on an average a normal surgey lasts for 1.5 hours.
Intervention code [1] 237047 0
Treatment: Devices
Comparator / control treatment
The first 100 consecutive total shoulder arthroplasties until the one year follow up were monitored using objective and subjective outcome parameters.
Control group
Historical

Outcomes
Primary outcome [1] 240528 0
Patient benefit measured with SPADI (Shoulder Pain and Disability Index)and Constant Murley score at the joint level,
with the QuickDASH (Disability of the Arm, Shoulder and Hand questionnaire) for the upper extremity and the SF-36 (Quality of Life) mental score as a generic tool
Timepoint [1] 240528 0
Subjects will be seen at Pre-operative, post-operative, 6 months, 1year, 2 years, 5 years and 10 years time point
Secondary outcome [1] 257083 0
Active and Passive Range of motion - measured by Goniometer
Timepoint [1] 257083 0
Subjects will be seen at Pre-operative, post-operative, 6 months, 1year, 2 years, 5 years and 10 years time point
Secondary outcome [2] 257296 0
Strength of Abduction - measured by spring balance.
Timepoint [2] 257296 0
Subjects will be seen at Pre-operative, post-operative, 6 months, 1year, 2 years, 5 years and 10 years time point
Secondary outcome [3] 257297 0
Rate of implant related complications
The following implant related compications will be assessed.
-humeral fracture
-luxation/dislocation
-acromion fracture
-rupture of glenoid component
-ectopic bone formation
-superficial wound infection
-deep joint infection
-clinical deep vein thrombosis
-death
-reoperation
-total revision
-partial revision
Timepoint [3] 257297 0
The assessment is completed by responsible investigator, if the any complication occurs.

Eligibility
Key inclusion criteria
1. Primary or secondary omarthrosis as an indication for primary total shoulder arthroplasty
2. Massive rotator cuff rupture
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with the following critieria will be not eligible to participate in the study.

1. Previous ipsilateral shoulder arthroplasty
2. Late stage rotator cuff disease (Only for PROMOS standard prosthesis)
3. Acute shoulder trauma
4. General medical contraindication to surgery
5. Legal incompetence
6. Tumour / malignoma
7. Recent history of substance abuse
8. Any disease process that would preclude accurate evaluation (e.g.
neuromuscular, psychiatric or metabolic disorder)
9 Known hypersensitivity to the materials used
10. Bacterial infection at the time point of operation

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Product unavailable in Australia
Date of first participant enrolment
Anticipated
10/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 1926 0
Germany
State/province [1] 1926 0
Country [2] 1927 0
Switzerland
State/province [2] 1927 0

Funding & Sponsors
Funding source category [1] 237458 0
Commercial sector/Industry
Name [1] 237458 0
Smith&Nephew Surgical Pty Ltd
Country [1] 237458 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Smith&Nephew Surgical Pty Ltd
Address
85, Waterloo Road, North Ryde - 2113
Country
Australia
Secondary sponsor category [1] 236943 0
None
Name [1] 236943 0
Address [1] 236943 0
Country [1] 236943 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 239588 0
Ethics committee address [1] 239588 0
Ethics committee country [1] 239588 0
Date submitted for ethics approval [1] 239588 0
27/08/2009
Approval date [1] 239588 0
Ethics approval number [1] 239588 0

Summary
Brief summary
Study withdrawn as product unavailable in Australia
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29990 0
Mr Not Available - Study is withdrawn prior to site selection or ethics application
Address 29990 0
Not Available - Study is withdrawn prior to site selection or ethics application
Country 29990 0
Australia
Phone 29990 0
+61298573802
Fax 29990 0
Email 29990 0
mausam.doctor@smith-nephew.com
Contact person for public queries
Name 13237 0
Mr Mausam Doctor
Address 13237 0
85, Waterloo Road, North Ryde - 2113
Country 13237 0
Australia
Phone 13237 0
+61 2 98573802
Fax 13237 0
Email 13237 0
mausam.doctor@smith-nephew.com
Contact person for scientific queries
Name 4165 0
Mr Mausam Doctor
Address 4165 0
85, Waterloo Road, North Ryde - 2113
Country 4165 0
Australia
Phone 4165 0
+61 2 98573802
Fax 4165 0
Email 4165 0
mausam.doctor@smith-nephew.com

No information has been provided regarding IPD availability


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.