| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN32335957 |
| Date ISRCTN assigned | 09/05/2007 |
| Local reference number(s) | 3474 |
| Public title | Prospective randomised study of Reverse shoulder Prosthesis and Hemiarthroplasty for elderly patients with proximal humeral fractures |
| Scientific title |
|
| Acronym | Reverse Prosthesis vs Hemiarthroplasty |
| Disease/condition/study domain | Elderly patients with shoulder fracture that require arthroplasty |
| 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. |
| Design/methodology | Double blind randomised controlled trial |
| Research ethics review | Will be submitted to Central Office for Research Ethics Committee as well as Local Research & Ethics Committee, pending as of 09/05/2007. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/06/2007 |
| Anticipated end date | 31/05/2008 |
| Status of trial | Ongoing |
| Target number of participants | 120 |
| Interventions | Either a Reverse Shoulder Prosthesis or a Hemiarthroplasty for the fracture. All other aspects of treatment including follow up will be the same.
|
| Primary outcome measure(s) | 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 measure(s) | 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. |
| Sources of funding | Royal Liverpool and Broadgreen University Hospital NHS Trust (UK) |
| Sponsor name | Royal Liverpool and Broadgreen University Hospital NHS Trust (UK) |
| Sponsor details | Prescot Street
Liverpool
United Kingdom
L7 8XP |
| Sponsor website | http://www.rlbuht.nhs.uk/ |
| Contact name | Mr C Sinopidis |
| Contact details | Link 4Z
Royal Liverpool and Broadgreen University Hospitals
Prescot Street
Liverpool
United Kingdom
L7 8XP |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN32335957 |
| Date last extracted from ISRCTN register | 17/04/2008 |
