Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
3474
Study information
Scientific title
Prospective randomised study of Reverse shoulder Prosthesis and Hemiarthroplasty for elderly patients with proximal humeral fractures
Acronym
Reverse Prosthesis vs Hemiarthroplasty
Study hypothesis
The aim is to find which of the two (Reverse Shoulder Prosthesis or Hemiarthroplasty) is the better prosthesis in the elderly patients, with a shoulder fracture and need for arthroplasty.
Ethics approval
Central Office for Research Ethics Committee and Liverpool Local Research Ethics Committee, 10/10/2007, ref: 07/Q1502/59
Study design
Double-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Elderly patients with shoulder fracture that require arthroplasty
Intervention
Either a Reverse Shoulder Prosthesis or a Hemiarthroplasty for the fracture. All other aspects of treatment including follow up will be the same.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
1. Activities of daily living of American Shoulder and Elbow Surgeons (ASES)
2. Simple shoulder test
These will be measured at one year after the operation
Secondary outcome measures
1. 36-item Short Form health survey (SF-36)
2. University of California and Los Angeles (UCLA) scores
3. Radiological outcome
These will be measured at one year after the operation
Overall trial start date
01/06/2007
Overall trial end date
31/05/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Elderly patients who require arthroplasty for shoulder fracture
2. Patients agreeing to participate in the study
3. Patients who are able to give consent
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Patients who are younger than 70 years
2. Poly-trauma patients
3. Multiple fractures
4. Open fracture
5. Previous operation to the shoulder
6. Dementia
7. Nerve or vessel injury
8. Unable to understand English
Recruitment start date
01/06/2007
Recruitment end date
31/05/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Liverpool and Broadgreen University Hospitals
Liverpool
L7 8XP
United Kingdom
Sponsor information
Organisation
Royal Liverpool and Broadgreen University Hospital NHS Trust (UK)
Sponsor details
Prescot Street
Liverpool
L7 8XP
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal Liverpool and Broadgreen University Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list