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 |
| Protocol serial number | 3474 |
| Sponsor | Royal Liverpool and Broadgreen University Hospital NHS Trust (UK) |
| Funder | Royal Liverpool and Broadgreen University Hospital NHS Trust (UK) |
- 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
Scientific
Link 4Z
Royal Liverpool and Broadgreen University Hospitals
Prescot Street
Liverpool
L7 8XP
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(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 |
| Key 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 |
| Completion date | 31/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Royal Liverpool and Broadgreen University Hospitals
Liverpool
L7 8XP
United Kingdom
L7 8XP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/10/2017: No publications found, verifying study status with principal investigator.
