Comparison of two shoulder replacement methods after trauma
| ISRCTN | ISRCTN21981284 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21981284 |
| Secondary identifying numbers | Protocol 1.9 |
- Submission date
- 13/01/2015
- Registration date
- 27/01/2015
- Last edited
- 03/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
Injuries to the shoulder joint are common and occur more frequently in elderly patients who fall from standing height. In more severe breaks to the shoulder joint an operation can be performed to prevent pain and deformity. This is often done by replacing the broken head of the joint with a metal ball known as a hemiarthroplasty (shoulder replacement). There is growing debate about the most appropriate treatment of these injuries. There is a newer implant called a reverse total shoulder replacement in which, in addition to replacing the head, the socket is replaced in the shoulder joint. This reverse polarity shoulder replacement has been growing in popularity for treating these injuries. This study compares the results of hemiarthroplasty and reverse total shoulder replacement in severely broken shoulder joints to guide future treatment.
Who can participate?
Adults aged at least 65 years who sustained a severely broken shoulder joint within the last three weeks.
What does the study involve?
Participants are randomly allocated into one of two groups. All participants have shoulder replacement surgery but those in group 1 have a hemiarthoplasty and those in group 2 have a reverse total shoulder replacement. Participants are not told what type of replacement they are having. After surgery, both groups of participants are treated with immobilisation in a sling for four weeks followed by physiotherapy. All participants are seen at six weeks, three months, one year and two years, when they are asked to complete a questionnaire and have an examination. X-rays are also routinely taken during return visits.
What are the possible benefits and risks of participating?
The major benefits of having surgery is that provides good pain relief and function of the shoulder joint for both groups of participants. All the surgical procedures are performed under general anaesthetic. Although anaesthesia is extremely safe with modern techniques, there are still very small risks involved. Some people experience nausea, vomiting and/or dizziness. These are reduced with modern drugs. It is important that participants tell the research team about any medical problems. The surgical procedure itself carries some risks including dislocation of the joint and possibility of further breaks in the bone. There is a small chance of developing wound infection. This may require treatment with antibiotics. There is also a small risk of damage to the adjacent nerves and vessels in the shoulder.
Where is the study run from?
The study is being run from multiple orthopaedic centres in the UK who are experienced in both the management of these injuries and conducting studies of this kind.
When is the study starting and how long is it expected to run for?
June 2013 to May 2019
Who is funding the study?
Tornier UK Limited (UK)
Who is the main contact?
Professor A C Watts
Contact information
Public
Wrightington Hospital
Hall Lane
Appley Bridge
Wigan
Lancashire
WN6 9EP
United Kingdom
Study information
| Study design | Multicentre randomised controlled interventional 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 below to request a patient information sheet |
| Scientific title | Shoulder Hemiarthroplasty versus Reverse Total Shoulder Arthroplasty for Trauma |
| Study acronym | SHeRPA |
| Study hypothesis | There is no difference in outcome at one year for proximal humerus fractures treated with hemiarthroplasty or reverse shoulder arthroplasty. |
| Ethics approval(s) | National Research Ethics Committee (REC) North West – Greater Manchester West, 07/05/2013, ref: 12/NW/0724 |
| Condition | 3 or 4 part proximal humerus fractures |
| Intervention | 1. Proximal humerus hemiarthroplasty (intervention 1) 2. Reverse polarity total shoulder arthroplasty (intervention 2) |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Difference in the mean Constant Score at 12 months post-operatively |
| Secondary outcome measures | Difference in the mean Constant score, quickDASH score, Oxford shoulder score and ASES score at two years post-operatively |
| Overall study start date | 05/06/2013 |
| Overall study end date | 01/05/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Fifty (50) patients |
| Participant inclusion criteria | A patient over the age of 65 years within three weeks of a three or four part proximal humerus fracture and who is fit for surgical intervention |
| Participant exclusion criteria | 1. Dementia 2. Refusal of consent 3. Patient unfit for reverse polarity arthroplasty 4. Glenoid fracture 5. Axillary nerve palsy |
| Recruitment start date | 01/08/2013 |
| Recruitment end date | 01/05/2017 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Appley Bridge
Wigan
WN8 9EP
United Kingdom
Exeter
Devon
EX2 5DW
United Kingdom
Bristol
BS16 1LE
United Kingdom
York
North Yorkshire
YO31 8HE
United Kingdom
Glasgow
G4 0SF
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development
Hall Lane
Appley Bridge
Wigan
Lancashire
WN6 9EP
England
United Kingdom
"ROR" |
https://ror.org/00y112q62 |
|---|
Funders
Funder type
Industry
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 | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
On 03/12/2015 the following changes were made to the trial record:
1. The recruitment end date was changed from 31/07/2015 to 01/05/2017.
2. The overall trial end date was changed from 01/08/2017 to 01/05/2019.
