None listed
Conditions
Brief summary
Study withdrawn as product unavailable in Australia
Interventions
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 polyeth
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.
Sponsors
Smith&Nephew Surgical Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Primary or secondary omarthrosis as an indication for primary total shoulder arthroplasty 2. Massive rotator cuff rupture
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
Outcome results
None listed