Condition category
Injury, Occupational Diseases, Poisoning
Date applied
28/07/2014
Date assigned
02/09/2014
Last edited
29/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
When a person has a broken hip, they have a fracture (crack or break) at the top of the thigh bone (femur) nearest to the hip joint. A partial, or half, hip replacement (hemiarthroplasty) is a common, well established, treatment for this condition. Here, we want to compare the performance of two different types of hip replacements, a Thompson’s hemiarthroplasty and a Exeter Trauma Stem, and see whether one is better than the other.

Who can participate?
Adults patients aged 65 or over who have a hip fracture that needs to be treated by a hemiarthroplasty.

What does the study involve?
Patients are randomly allocated into one of two groups. Those in group 1 are treated with a Thompson’s hemiarthroplasty. Those in group 2 are treated with a Exeter Trauma Stem. After surgery all patients are x-rayed and complete questionnaires. They also receive the usual (standard practice) physiotherapy. Patients are then invited to follow-up clinics at 6 weeks, 3 months and 1 year after their surgery to see how well they are doing and to look out for any complications.

What are the possible benefits/risks of participating?
There may be no direct benefit to any patient taking part in the study. However the information provided by the study will help improve current clinical practice. We do not think there is any increased risk to patients that take part in the study.

Where is the study run from?
Torbay Hospital, South Devon Healthcare NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
September 2014 to September 2015

Who is funding the study?
Torbay Medical Research Fund (UK)

Who is the main contact?
Mr Gordon Higgins
gordonhiggins@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Mr Gordon Higgins

ORCID ID

Contact details

Trauma and Orthopaedics department
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom
+44 (0) 1803 654969
gordonhiggins@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SD-00131

Study information

Scientific title

Comparing outcomes of fractured neck of femur patients treated with Thompsons hemiarthroplasty versus Exeter Trauma Stem: a randomised controlled trial

Acronym

Study hypothesis

Does the Exeter Trauma Stem improve patients mortality, mobility and quality of life compared to the current Thompsons hemiarthroplasty?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Available on request to sdhct.research@nhs.net

Condition

Trauma & Orthopaedics - Fractured neck of femur

Intervention

Patients diagnosed with a fractured neck of the femur will be randomised into one of two groups. Group 1 will be treated with Thompsons hemiarthroplasty and group 2 with Exeter Trauma stem. They will undergo the following:
1. Non Clinical:
1.1. Pre-operative recruitment, consent and pre-operative questionnaires
1.2. Post-operative functional outcome questionnaire at 1 month, 3 months, and 1 year
2. Clinical:
2.1. Hip Operation (to receive hip hemiarthoplasty)
2.2. Post-operative radiographs (6 weeks, 3 months and 1 year)
2.3. Clinical assessment (6 weeks, 3 months, and 1 year)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Patient related outcome measures (including EQ-5D, SF-36 and Oxford scores) at pre-operation and post operation

Secondary outcome measures

1. Complications post surgery
2. Radiographic appearance of hip implants (post surgery)
3. Patient satisfaction (post surgery)

Overall trial start date

30/09/2014

Overall trial end date

29/09/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with intra-capsular fractured neck of femur
2. Patients fit enough for surgery
3. Patients able to give informed consent, or an advocate (unpaid carer/person interested in patient's welfare) is available to grant consent on behalf of the patient
4. Patients > 65 years of age

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Patients unfit for operative intervention
2. Patients who choose not to be included in the trial
3. Patients who are not from the local area and could not attend follow-up
4. Patients who do not speak English and an interpreter is not available at consent
5. Patients who require Total Hip Replacement according to NICE guidelines
6. Where consent for patient or an advocate is not possible
7. Patients < 65 years of age

Recruitment start date

30/09/2014

Recruitment end date

29/09/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Trauma and Orthopaedics department
Torquay
TQ2 7AA
United Kingdom

Sponsor information

Organisation

South Devon Healthcare NHS Foundation Trust (UK)

Sponsor details

C/O Manager of Research and Development
Research and Development Department
Horizon Centre
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom
+44 (0) 1803 656635
sdhct.research@nhs.net

Sponsor type

Hospital/treatment centre

Website

http://www.sdhct.nhs.uk

Funders

Funder type

Research organisation

Funder name

Torbay Medical Research fund (Project number: 113) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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