Condition category
Musculoskeletal Diseases
Date applied
14/03/2007
Date assigned
09/05/2007
Last edited
14/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr C Sinopidis

ORCID ID

Contact details

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

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

We aim 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 below 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 measures

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

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

http://www.rlbuht.nhs.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes