Prospective randomised study of reverse shoulder prosthesis and hemiarthroplasty for elderly patients with proximal humeral fractures

ISRCTN	ISRCTN32335957
DOI	https://doi.org/10.1186/ISRCTN32335957
Secondary identifying numbers	3474

Submission date: 14/03/2007
Registration date: 09/05/2007
Last edited: 11/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr C Sinopidis
Scientific

Link 4Z
Royal Liverpool and Broadgreen University Hospitals
Prescot Street
Liverpool
L7 8XP
United Kingdom

Study information

Study design	Double-blind randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Prospective randomised study of Reverse shoulder Prosthesis and Hemiarthroplasty for elderly patients with proximal humeral fractures
Study acronym	Reverse Prosthesis vs Hemiarthroplasty
Study objectives	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(s)	Central Office for Research Ethics Committee and Liverpool Local Research Ethics Committee, 10/10/2007, ref: 07/Q1502/59
Health condition(s) or problem(s) studied	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
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 study start date	01/06/2007
Completion date	31/05/2008

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	120
Key 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
Key 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
Date of first enrolment	01/06/2007
Date of final enrolment	31/05/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Liverpool and Broadgreen University Hospitals

Liverpool
L7 8XP
United Kingdom

Sponsor information

Royal Liverpool and Broadgreen University Hospital NHS Trust (UK)
Hospital/treatment centre

Prescot Street
Liverpool
L7 8XP
England
United Kingdom

Website	http://www.rlbuht.nhs.uk/
"ROR"	https://ror.org/009sa0g06

Funders

Funder type

Government

Royal Liverpool and Broadgreen University Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

11/10/2017: No publications found, verifying study status with principal investigator.