Condition category
Injury, Occupational Diseases, Poisoning
Date applied
13/01/2015
Date assigned
27/01/2015
Last edited
03/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Public

Primary contact

Prof Adam Watts

ORCID ID

Contact details

Wrightington Hospital
Hall Lane
Appley Bridge
Wigan
Lancashire
WN6 9EP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol 1.9

Study information

Scientific title

Shoulder Hemiarthroplasty versus Reverse Total Shoulder Arthroplasty for Trauma

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

National Research Ethics Committee (REC) North West – Greater Manchester West, 07/05/2013, ref: 12/NW/0724

Study design

Multicentre randomised controlled interventional 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

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

Phase

Drug names

Primary outcome measures

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 trial start date

05/06/2013

Overall trial end date

01/05/2019

Reason abandoned

Eligibility

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 type

Patient

Age group

Senior

Gender

Both

Target number of participants

Fifty (50) patients

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

United Kingdom

Trial participating centre

Wrightington Wigan and Leigh NHS Trust
Hall Lane Appley Bridge
Wigan
WN8 9EP
United Kingdom

Trial participating centre

Royal Devon and Exeter NHS Foundation Trust
Barrack Road Exeter
Devon
EX2 5DW
United Kingdom

Trial participating centre

Frenchay Hospital, North Bristol NHS Trust
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom

Trial participating centre

York Teaching Hospitals NHS Foundation Trust
Wigginton Road York
North Yorkshire
YO31 8HE
United Kingdom

Trial participating centre

Glasgow Royal Infirmary
84 Castle Street
Glasgow
G4 0SF
United Kingdom

Sponsor information

Organisation

Wrightington Hospital

Sponsor details

Research and Development
Hall Lane
Appley Bridge
Wigan
Lancashire
WN6 9EP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Tornier UK Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

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.