An investigation in people aged 60 years and over with a hip fracture to determine whether fixing the broken hip bone or replacing the hip joint gives the patient a better quality of life after 4 months
| ISRCTN | ISRCTN28566489 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28566489 |
| EudraCT/CTIS number | 2020-003719-83 |
| IRAS number | 287755 |
| Secondary identifying numbers | IRAS 287755, CPMS 49158, HTA - NIHR128399 |
- Submission date
- 10/05/2021
- Registration date
- 14/05/2021
- Last edited
- 04/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Every year around 70,000 people in the UK break their hip. Hip fractures are a common and very serious injury in older patients, similar in impact to a major stroke. This study will investigate two treatments for one specific type of hip fracture. Currently, surgeons either repair the fracture with screws or remove and replace the broken piece of bone, but doctors do not know which is better for patients. This study will examine whether either fixing the broken bone or replacing the hip joint gives a better result for people 60 years and over with hip fractures from at least 40 hospitals across the UK. The researchers want to look at how well people feel and how active they are following their fracture. They will also work out the cost of the two treatments for the individual, for the health service and in terms of social support in the year following the fracture.
Who can participate?
Patients aged 60 and over with a hip fracture that in the opinion of the treating surgeon may benefit from surgical treatment
What does the study involve?
If people agree to take part, they will be allocated using a process called randomisation which makes sure that the groups are similar and the comparison between the two treatments is fair. Participants are randomised to fixing the broken bone or replacing the hip joint. Before and after their operation all the patients will have the usual ward care, rehabilitation and follow up that is standard practice at their hospital.
The researchers will ask patients about their health, pain, walking ability and other daily activities, as well as any complications and specific costs. Their answers will be collected at the outset, and at 6 weeks, 4 months and 1 year after confirmed diagnosis of their hip fracture, and the results from the two groups compared. A few questions will be asked each year for 5 years to find out about any longer-term effects. The researchers will also ask people for their permission to use de-identified information, which means that it is unlikely that they can be identified from the records received, from national databases that are already being routinely collected.
This study falls under the WHITE Platform framework and has been developed by a team of patient representatives, clinical experts in trauma orthopaedics, study management specialists, experienced statisticians and health economists. The Oxford Clinical Trials Research Unit, based at the University of Oxford, will assure the quality of the study. A monitoring committee of patient representatives and independent experts will oversee the progress and conduct of the study.
What are the possible benefits and risks of participating?
The risks of hip surgery include infection, blood clots, damage to nerves and blood vessels in the surgical area, and the risks associated with the anaesthetic. For hip fixation, there is a risk of requiring further surgery if healing is unsuccessful. For hip replacement surgery, there is a risk of dislocation and of further fracture around the implant. The risks are not altered by taking part in this study.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
May 2019 to December 2028
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Rhys Painton
White11-Fruiti@ndorms.ox.ac.uk
Contact information
Public
Oxford Trauma and Emergency Care
Kadoorie Centre. Level 3
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 223111 |
|---|---|
| white11-Fruiti@ndorms.ox.ac.uk |
Scientific
Oxford Trauma and Emergency Care
Kadoorie Centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0002-8857-5743 |
|---|---|
| Phone | +44 (0)1865 223115 |
| Juul.achten@ndorms.ox.ac.uk |
Study information
| Study design | Pragmatic multicentre two-arm randomized superiority comparison with parallel economic analyses follow-up |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | World Hip Trauma Evaluation – FRUITI: Fix or Replace Undisplaced Intracapsular fractures Trial of Interventions |
| Study acronym | WHiTE 11-FRUITI |
| Study hypothesis | To establish if there are differences in health-related quality-of-life (HRQoL) at 4 months post-diagnosis of a hip fracture between patients with a minimally displaced intracapsular fracture treated with an internal fixation or a hemiarthroplasty. |
| Ethics approval(s) | Approved 14/01/2021, Berkshire Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle-upon-Tyne, NE2 4NQ, UK; +44 (0)2071048138; berkshire.rec@hra.nhs.uk), REC ref: 20/SC/0452 |
| Condition | Minimally displaced intracapsular hip fracture |
| Intervention | WHiTE 11-FRUITI is a randomised comparison appended to the World Hip Trauma Evaluation (WHiTE) Platform. WHiTE is a platform trials framework, designed to efficiently deliver multiple randomised comparisons of interventions for patients aged 60 years and over with a hip fracture. The platform and its appended randomised comparisons are governed by one single set of ethical and regulatory approvals and an explicit legal basis and processing purpose for the use of patient-level data. The Platform affords a common core dataset and documentation. Individual randomised comparisons are not dependent on each other and each will have its unique start and stop dates and publication of results without compromising the integrity of the platform. Participants will be randomised using block randomisation on a 1:1 basis to arthroplasty or internal fixation, stratified by recruitment centre: 1. Arthroplasty: Hemiarthroplasty or total hip arthroplasty. Patient position, surgical approach, implant and surgical technique will be chosen by the operating surgeon. 2. Internal fixation: Sliding hip screw or cannulated screws. Fixation will be achieved using a technique and implant chosen by the operating surgeon. Longer-term follow-up will be achieved using patient-reported outcomes and routinely collected data at 5 years. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Health-related quality of life measured using the EuroQol EQ-5D-5L at baseline (retrospective pre-injury), 6 weeks, 4, 12, 24, 36, 48 and 60 months post-diagnosis of a hip fracture |
| Secondary outcome measures | 1. Subjective mobility status measured using the UK National Hip Fracture Database Mobility Scale at 6 weeks, 4 and 12 months post-diagnosis of a hip fracture 2. Residential status measured using the UK National Hip Fracture Database Residential Status at 6 weeks, 4 and 12 months post-diagnosis of a hip fracture 3. Mortality risk using death notification up to 12 months post-diagnosis of a hip fracture 4. Risk and pattern of complications measured using a bespoke complications questionnaire and routinely collected hospital data up to 5 years post-diagnosis of a hip fracture 5. Resource use from an NHS and personal social services perspective calculated using a bespoke resource use questionnaire up to 12 months post-diagnosis of a hip fracture 6. Pain measured using a visual analogue scale at 6 weeks, 4 and 12 months post-diagnosis of a hip fracture 7. Objective mobility status measured using the Short Physical Performance Battery at 6 weeks post-diagnosis of a hip fracture |
| Overall study start date | 01/05/2019 |
| Overall study end date | 31/12/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 60 Years |
| Sex | Both |
| Target number of participants | 878 |
| Participant inclusion criteria | Platform inclusion: All patients 60 years of age and over presenting to a WHiTE recruitment centre for treatment of a hip fracture Additional inclusion criteria for FRUITI: A minimally displaced intracapsular hip fracture that in the opinion of the treating surgeon may benefit from surgical treatment |
| Participant exclusion criteria | Platform: Does not meet inclusion criteria Additional exclusion criteria for FRUITI: 1. The fracture is only apparent on cross-sectional imaging 2. In the opinion of the treating surgeon the fracture cannot be fixed without a reduction manoeuvre 3. The fracture is complicated by local tumour deposits 4. There is clinically relevant pre-existing osteoarthrosis (OA) of the ipsilateral hip joint |
| Recruitment start date | 10/06/2021 |
| Recruitment end date | 01/08/2023 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Liverpool
L9 7AL
United Kingdom
Truro
TR1 3LJ
United Kingdom
Bath
BA1 3NG
United Kingdom
Bristol
BS10 5NB
United Kingdom
Cardiff
CF14 4XW
United Kingdom
TS4 3BS
United Kingdom
Taunton
TA1 5DA
United Kingdom
Reading
RG1 5AN
United Kingdom
Oldham
OL1 2JH
United Kingdom
Coventry
CV2 2DX
United Kingdom
Hazel Grove
Stockport
SK2 7JE
United Kingdom
Leicester
LE1 5WW
United Kingdom
Wakefield
WF1 4DG
United Kingdom
Longfleet Road
Poole
BH15 2JB
United Kingdom
St. Leonards-on-sea
TN37 7RD
United Kingdom
Southport
PR8 6PN
United Kingdom
Doncaster
DN2 5LT
United Kingdom
Belvedere Road
Burton-on-trent
DE13 0RB
United Kingdom
Luton
LU4 0DZ
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Leytonstone
London
E11 1NR
United Kingdom
Oxford Road
Banbury
OX16 9AL
United Kingdom
Derriford
Plymouth
PL6 8DH
United Kingdom
Basingstoke
RG24 9NA
United Kingdom
Eccles
Salford
M6 8HD
United Kingdom
Willesborough
Ashford
TN24 0LZ
United Kingdom
Cramlington
NE23 6NZ
United Kingdom
Ashton-under-lyne
OL6 9RW
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Administration Block
West Wales General Hospital
Carmarthen
SA31 2AF
United Kingdom
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Boston
PE21 9QS
United Kingdom
Yeovil
BA21 4AT
United Kingdom
Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom
Wrexham Technology Park
Wrexham
LL13 7TD
United Kingdom
Aylesbury
HP21 8AL
United Kingdom
Bodelwyddan
Rhyl
LL18 5UJ
United Kingdom
Stoke-on-trent
ST4 6QG
United Kingdom
Wythenshawe
Manchester
M23 9LT
United Kingdom
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Frimley
Camberley
GU16 7UJ
United Kingdom
Blackburn
BB2 3HH
United Kingdom
London
SE13 6LH
United Kingdom
Kettering
NN16 8UZ
United Kingdom
Gloucester
GL1 3NN
United Kingdom
Bordesley Green
Birmingham
B9 5ST
United Kingdom
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
Larbert
FK5 4WR
United Kingdom
220 the Vale
London
NW11 8SR
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Aberdeen
AB25 2ZN
United Kingdom
London
SE18 4QH
United Kingdom
Sponsor information
University/education
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
| Phone | +44 (0)1865289885 |
|---|---|
| ctrg@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Private sector organisation / Research institutes and centers
- Alternative name(s)
- NIHR Biomedical Research Centre, Oxford, OxBRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/03/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The protocol will be published before recruitment has been completed. The statistical analysis plan will be published before the final data has been collected. The main clinical results and health economic evaluation will be published in high impact peer-reviewed journals after completion of the initial 1 year follow-up period. Further publications are expected to report on the long-term outcomes for these patients. |
| IPD sharing plan | Data access requests should be made to Prof. Matthew Costa (Matthew.costa@ndorms.ox.ac.uk) and Prof. Xavier Griffin (X.griffin@qmul.ac.uk). Requests can be made 2 years after the publication of the trial results. The decision on the level of access granted and the purpose for which it might be made available will be guided by the Oxford Clinical Trials Research Unit and University of Oxford policies regarding data sharing that are in place at the time of the request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 7.0 | 31/08/2023 | 02/10/2024 | No | No |
| Protocol file | version 6.0 | 16/12/2022 | 02/10/2024 | No | No |
Additional files
Editorial Notes
04/10/2024: Study participating centre Queen Elizabeth Hospital was added.
02/10/2024: The following changes were made:
1. A study contact was updated.
2. The following study participating centres were added: Pinderfields Hospital, Poole Hospital, Conquest Hospital, Southport and Formby District General, Doncaster Royal Infirmary, Burton Hospital, Luton & Dunstable University Hospital, John Radcliffe Hospital, Whipps Cross University Hospital, Horton General Hospital, Derriford Hospital, Basingstoke and North Hampshire, Salford Royal Hospital, William Harvey Hospital, Northumbria Specialist Emergency Care Hospital, Tameside General Hospital, Addenbrooke's Hospital, Glangwili Hospital, Mainstone and Tunbridge Wells, Milton Keynes, Pilgrim Hospital, Yeovil District Hospital, Ysbyty Gwynedd Hospital, Wrexham Maelor Hospital, Stoke Mandeville Hospital, Glan Clwyd Hospital, Royal Stoke Hospital, Wythenshawe Hospital, Manchester Royal Infirmary, Frimley Park Hospital, Royal Blackburn Hospital, Lewisham University Hospital, Kettering General Hospital, Gloucestershire Royal Hospital, Heartlands Hospital, St Helier's Hospital, Forth Valley, King's College, Sunderland Royal Hospital, and Aberdeen Royal Infirmary; and Scotland was added to the Countries of recruitment.
3. The master protocol and protocol appendix were added as additional files.
15/06/2021: The recruitment start date was changed from 01/06/2021 to 10/06/2021.
10/05/2021: Trial's existence confirmed by the NIHR.
