Comparing outcomes of fractured neck of femur patients treated with Thompsons hemiarthroplasty versus Exeter Trauma Stem

ISRCTN	ISRCTN42349821
DOI	https://doi.org/10.1186/ISRCTN42349821
Secondary identifying numbers	SD-00131

Submission date: 28/07/2014
Registration date: 02/09/2014
Last edited: 23/01/2019

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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 Thompsons 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 Thompsons 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

Contact information

Mr Gordon Higgins
Scientific

Trauma and Orthopaedics department
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom

Phone	+44 (0) 1803 654969
Email	gordonhiggins@nhs.net

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Available on request to sdhct.research@nhs.net
Scientific title	Comparing outcomes of fractured neck of femur patients treated with Thompsons hemiarthroplasty versus Exeter Trauma Stem: a randomised controlled trial
Study objectives	Does the Exeter Trauma Stem improve patients mortality, mobility and quality of life compared to the current Thompsons hemiarthroplasty?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	30/09/2014
Completion date	29/09/2015
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	30
Key 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
Key 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
Date of first enrolment	30/09/2014
Date of final enrolment	29/09/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Trauma and Orthopaedics department

Torquay
TQ2 7AA
United Kingdom

Sponsor information

South Devon Healthcare NHS Foundation Trust (UK)
Hospital/treatment centre

C/O Manager of Research and Development
Research and Development Department
Horizon Centre
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
England
United Kingdom

Phone	+44 (0) 1803 656635
Email	sdhct.research@nhs.net
Website	http://www.sdhct.nhs.uk
"ROR"	https://ror.org/05374b979

Funders

Funder type

Research organisation

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

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	Not provided at time of registration
IPD sharing plan

Editorial Notes

23/01/2019: Study abandoned due to lack of funding
20/12/2017: No publications found, verifying study status with principal investigator.