Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Fractures of the proximal femur (hip fractures) are a significant medical problem. The number of hip fractures is increasing and is associated with significant problems for both the patient and healthcare providers. About 40 per cent of hip fractures are intra-capsular (within the joint capsule). The blood supply to part of the hip joint is lost and a hip replacement is required. The standard treatment for many of these fractures is hip arthroplasty (replacement); either hemiarthroplasty (replacing half the hip joint) or total hip arthroplasty (replacing the whole hip joint). There is currently debate about which is the best hemiarthroplasty to use. To date, the most commonly used replacement hip implants are the Thompson’s stem and the Exeter Trauma Stem. The Thompson’s stem has been used extensively in the UK for over 50 years but currently does not have an Orthopaedic Device Evaluation Panel (ODEP rating), a measure of how long the implant lasts, presumably because of there is only a limited amount of information available on them. The recent guidance on hip fracture management recommends the use of ‘proven’ cemented stem designs with an ODEP rating of at least 3B (97% survival at 3 years), instead of the Thompson’s stem. Many clinicians believe the modern characteristics of the Exeter Trauma stem would improve the functioning of the joint after surgery. We want to find out whether there is a difference in the health of patients 4 months after being given a Thompsons Stem hip replacement compared to those given a Exeter stems hip replacement.

Who can participate?
Adults aged at least 60 with a hip fracture and needing a hip hemiarthroplasty.

What does the study involve?
Participants are randomly allocated to receive a Thompsons Stem hip replacement or a Exeter stems hip replacement. They are all asked to fill in a quality-of-life questionnaire 4 months after surgery and clinical assessments are made to compare the two implants.

What are the possible benefits and risks of participating?
There is no specific advantage for patients taking part in the study. However, the information we get from this study should help us to decide which treatment is best to use for patients with this type of injury in the future. Any operation for a hip fracture carries some risks, but they are the same for both types of hip replacement and are faced by all patients facing a hip replacement. The risks of surgery include the risk of bleeding, risk of blood clots, risk of damage to nerves and blood vessels in the surgical area and the risk associated with the anaesthetic. Patients will have routine X-rays taken of their hip before and after the operation, to evaluate the hip replacement. The dose of radiation they will receive is equivalent to around 2 months of normal background radiation and is the same for all patients who have a hip replacement for a hip fracture.

Where is the study run from?
The study takes place from the following centres in the UK:
1. Northumbria Healthcare NHS Foundation Trust
2. Newcastle Hospitals NHS Foundation Trust
3. South Tees NHS Foundation Trust
4. University Hospitals of Leicester NHS Trust.

When is study starting and how long is it expected to run for?
November 2014 to April 2016.

Who is funding the study?
Stryker (USA)

Who is the main contact?
Mr Mike Reed

Trial website

Contact information



Primary contact

Mr Mike Reed


Contact details

Northumbria Healthcare NHS Foundation Trust
Woodhorn Lane
NE63 9JJ
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

Protocol V 2.0 24.07.14; IRAS project ID: 158381

Study information

Scientific title

A randomised controlled trial comparing the Thompsons versus the Exeter® polished taper stem and Unitrax® head in the treatment of displaced intracapsular fractures of the proximal femur



Study hypothesis

Null Hypothesis: There is no difference in health status at 4 months post injury between patients over 60 years of age with an AO/OTA type B3 fracture of the proximal femur treated with an Exeter® polished taper/Unitrax® versus a Thompsons.

Ethics approval

NRES committee West Midlands –Coventry and Warwickshire; 14/10/2014; ref. 14/WM/1098

Study design

Multi centre multi-surgeon parallel two arm standard-of-care controlled randomised study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Proximal femur fractures


Hip hemiarthroplasty using either Thompson prosthesis or an Exeter® polished taper with Unitrax® head

Intervention type



Not Applicable

Drug names

Primary outcome measures

A validated, patient reported, quality of life questionnaire collected at 4 months post injury – EQ-5D

Secondary outcome measures

1. Radiological leg length discrepancy
2. Mortality
3. Re-operation and cause
4. Length of index hospital stay
5. Revision at 4 months

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

All patients presenting to the collaborative with an AO/OTA type B3 fracture of the proximal femur

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Patients younger than 60 years of age
2. Patients with pre-existing symptomatic hip arthritis
3. Patients who are managed non-operatively
4. Patients who the responsible Consultant Orthopaedic Surgeon believe will not benefit from hemiarthroplasty

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Northumbria Healthcare NHS Foundation Trust
NE63 9JJ
United Kingdom

Sponsor information


Northumbria Healthcare NHS Foundation Trust (UK)

Sponsor details

c/o Mrs Caroline Potts
Northumbria Healthcare NHS Foundation Trust
Woodhorn Lane
NE63 9JJ
United Kingdom
+44 (0)191 293 4087

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Stryker® (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

08/03/2016: The public title has been updated from the "Warwick Hip Trauma Evaluation" to the "World Hip Trauma Evaluation 3" at the request of the principal investigator.