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 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
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 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 trial start date
30/09/2014
Overall trial end date
29/09/2015
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list