Condition category
Injury, Occupational Diseases, Poisoning
Date applied
01/04/2019
Date assigned
08/04/2019
Last edited
17/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Plain English Summary

Background and study aims
Lateral Compression type-1 (LC-1) pelvic fractures occur when older adults with weak bones fall onto their side. Researchers are trying to find new treatments to help people have better outcomes. Currently, people are encouraged to move as much as they can tolerate, as soon as possible after the injury. LC-1 fractures can be painful and some people are not able to get up and walk for weeks. This can cause additional health problems such as chest infections, urinary tract infections, pressure sores, and blood clots. Until recently the hardware (screws and plates) used in surgery did not grip well in bones with osteoporosis so surgery was rare. Pelvic surgeons now think patients may benefit from a new technique called INFIX which uses a bar and screws to stabilise the pelvis. If people are able to get moving sooner, this may help them to get back to their normal activities and save money on rehabilitation and care. However, there can be risks and complications with any surgery, or having a general anaesthetic. The aim of this study is to find out which treatment is better for patients.

Who can participate?
Patients aged over 60 from hospitals who have had an LC-1 fracture and are having difficulty walking.

What does the study involve?
Participants are randomly allocated to either receive surgery with the INFIX or standard non-surgical treatment. Participants are assessed at the start of the study, then at two weeks, six weeks, 12 weeks, six months, and some participants at one year. Participants complete a few questionnaires, a walking assessment (at 12 weeks), and have x-rays to check healing at 12 weeks. The cost of both treatments is calculated relative to its benefits to find out which is better value for money for the NHS.

What are the possible benefits and risks of participating?
Both treatment options are routinely used in the NHS to treat this type of pelvic fracture. The possible advantages of having surgery are that the break in the pelvis is stabilised, which may lead to less pain when walking and doing everyday activities. Less painful movement may mean that patients are able to return to normal activities more quickly. The possible benefits of receiving non-operative management are that patients are not exposed to any of the risks associated with having an operation, which are discussed below. The possible risks related to surgical fixation include pain around the lower belly and stiffness in the hips. This usually improves after 48 hours or so as the body heals. After surgery there can be bleeding from the incision onto the dressing. This is continuously monitored and dressings will be changed as needed. The outside of the thigh may become numb or patients may experience a tingling sensation. If this occurs the metal work can be removed after the pelvis has healed. After surgery in the first 1-2 days some patients can experience confusion, this is related to the anaesthesia and improves over time. Rare risks include wound infection, if this were to occur it is treated with antibiotics. In rare cases of serious infection the screws and bar may need to be removed or replaced. In very rare cases there can be damage to nerves and blood vessels around the pelvis and groin. It is rare but some people can have a bad reaction to anaesthesia. There is the chance that further surgical procedures may need to be carried out for example to remove the metal work. Possible risks associated with non-operative management include rehabilitation taking longer because of ongoing pain. Usually the pain from the fracture settles down over 6-weeks or so but it can sometimes can last up to 2-3 months. If the pain from the fracture prevents a patient from getting up and going, they are at risk of developing conditions such as chest and urinary infections or bed/pressure sores. Some patients can become confused which is called delirium after their injury, particularly if they are struggling to get up out of bed due to pain. Occasionally, fractures do not heal up fully and they require surgery, although this is a rare problem.

Where is the study run from?
1. Barts Health NHS Trust
2. North Bristol NHS Trust
3. Cambridge University Hospitals NHS Foundation Trust
4. King's College Hospital NHS Foundation Trust
5. Brighton and Sussex University Hospitals NHS Trust
6. Oxford University Hospitals NHS Foundation Trust
7. South Tees Hospitals NHS Foundation Trust
8. NHS Lothian
9. Sheffield Teaching Hospitals NHS Foundation Trust
10. Cardiff & Vale University LHB
11. Plymouth Hospitals NHS Trust
12. Hull and East Yorkshire Hospitals NHS Trust
13. University Hospitals Coventry and Warwickshire NHS Trust
14. Leeds Teaching Hospitals NHS Trust
15. University Hospital Southampton NHS Foundation Trust
16. Aintree University Hospital NHS Foundation Trust
17. NHS Greater Glasgow and Clyde
18. St George's University Hospitals NHS Foundation Trust
19. Imperial College Healthcare NHS Trust
20. Nottingham University Hospitals NHS Trust
21. University Hospitals Birmingham NHS Foundation Trust
22. University Hospitals Of North Midlands NHS Trust
23. Salford Royal NHS Foundation Trust
24. Portsmouth Hospitals NHS Trust

When is the study starting and how long is it expected to run for?
October 2018 to March 2023

Who is funding the study?
National Institute for Health Research (NIHR)

Who is the main contact?
Liz Cook
liz.cook@york.ac.uk

Trial website

https://www.york.ac.uk/healthsciences/research/trials/research/trials/l1

Contact information

Type

Scientific

Primary contact

Mrs Liz Cook

ORCID ID

http://orcid.org/0000-0001-6902-0235

Contact details

York Trials Unit
University of York
York
YO10 5DD
United Kingdom
-
liz.cook@york.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

41261

Study information

Scientific title

Lateral compression type-1 fracture fixation in the elderly, a randomised controlled trial

Acronym

L1FE

Study hypothesis

Aim:
To investigate the clinical and cost effectiveness of surgical fixation with INFIX compared to non-surgical management of LC-1 fragility fractures in older adults.

The objectives are to:
1. Undertake a 12 month internal pilot to obtain robust estimates of recruitment and confirm trial feasibility.
2. Undertake a parallel group multi-centre randomised controlled trial to assess the effectiveness of surgical fixation with INFIX versus non-surgical management of LC-1 fragility fractures in older adults. The primary outcome is average patient quality of life and function, over the study time period, assessed by the patient-reported outcome measure, EQ-5D-5L (measured at 2 weeks, 6 weeks, 12 weeks and 6 months).
3. Undertake an economic evaluation to compare the cost-effectiveness of surgical fixation compared to non-surgical management to determine the most efficient provision of future care and to describe the resource impact on the NHS for the two treatment options.
4. Undertake a long term review of patient wellbeing (EQ-5D-5L and mortality) 12 months after entering the trial.

Ethics approval

Approved 16/07/2019, London - Harrow Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT), Tel: +44 (0)20 71048057, Email: nrescommittee.london-harrow@nhs.net, ref: 19/LO/0555

Study design

Randomised; Both; Design type: Treatment, Device, Surgery, Rehabilitation, Health Economic

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Lateral compression type-1 pelvic fracture

Intervention

Eligible and consenting patients will be randomly allocated to either surgical fixation or non-operative management.

Surgical fixation:
Surgical fixation of the pelvic fracture using INFIX, an anterior pelvic fixator device that is fitted internally. The technique involves percutaneous placement of long pedicle screws within the pelvic bone and connects them with a rod under the skin. Post-operatively, patients will receive physiotherapy as per standard of care

Non-operative management:
Standard care for LC-1 fractures in the UK is to mobilise patients as pain allows. Patients are routinely seen by a physiotherapy team, with the goals of physiotherapy to improve function, strength and range of movement in both legs, while aiming to get patients back to independent mobility as soon as possible.

Patients in both arms of the trial will also receive the standardised L1FE trial-specific, physiotherapy leaflet detailing suggested exercises to perform.

Courtesy telephone call/postcard sub-study:
The researchers will undertake an embedded randomised controlled trial to investigate the effectiveness on participant retention of making a courtesy telephone call, sending a courtesy postcard or neither within one month of participants being recruited into the L1FE trial. Participants will be randomly allocated to receive the courtesy telephone call, courtesy postcard, or no intervention. This sub-study should not represent any further burden to participants.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Average patient quality of life over the study time period, assessed by the patient-reported outcome measure, EuroQol 5 Dimensions (5L) utility score (EQ-5D-5L). The EQ-5D-5L is a validated generic patient-reported outcome measure (www.euroqol.org), including validation in patients with hip fractures and orthopaedic patients with cognitive impairment.; Timepoint(s): baseline, 2 weeks, 6 weeks, 12 weeks, 6-month time points as well as an optional 12 month follow up point for those recruited early within the study.

Secondary outcome measures

1. Physical function measured using Patient Reported Outcome Measures Information System (PROMIS) Lower Extremity Function at baseline, 2 weeks, 6 weeks, 12 weeks, 6 months
2. Physical function measured using Timed Up and Go Test (TUG) at 12 weeks
3. Mental health measured using PROMIS Scale v1.2 – Global Health Mental 2a at baseline, 2 weeks, 6 weeks, 12 weeks, 6 months
4. Pain measured by Numeric Rating Scale (NRS) at baseline, 2 weeks, 6 weeks, 12 weeks, 6 months
5. Delirium measured using Abbreviated Mental Test Score (AMTS) at baseline, 2 weeks, 12 weeks
6. Delirium measured using 4AT Rapid Assessment Test for Delirium at baseline, 2 weeks, 12 weeks
7. Complications measured using clinic review and/or patient self-report at 2 weeks, 12 weeks, 6 months
8. Mortality measured identified using central NHS records at 12 weeks, 6 months, 12 months (for those patients that agree to this additional follow-up)
9. Imaging - radiologic assessment of the pelvis performed at 12 weeks
10. Other outcomes: data on length of hospital stay, change of place of residence (e.g. own home to residential care home) and return to normal activities, measured using clinic review and/or patient self-report at 2 weeks, 6 weeks, 12 weeks, 6 months

Overall trial start date

01/10/2018

Overall trial end date

31/03/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 60 years or older
2. An LC-1 pelvic fracture is diagnosed, arising from a low energy fall
3. After 72 hours post-injury the patient is unable to mobilise independently or with supervision (with or without a walking aid) to a distance of around 3 meters and back, due to pelvic pain or perceived pelvic pain

Courtesy telephone call/postcard sub-study:
All participants recruited into the L1FE trial who consent to being contacted by telephone and by post will be eligible for the sub-study. There are no additional inclusion or exclusion criteria

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned Sample Size: 600; UK Sample Size: 600

Participant exclusion criteria

1. Unable to perform surgery within 10 days of injury
2. Surgery is contra-indicated because patient is not fit for anaesthetic (spinal or general) or soft tissue concerns
3. Patients who were non-ambulatory or required assistance walking, with or without a walking aid prior to their injury
4. Concomitant injury or poly-trauma that impedes mobilisation
5. Fracture configurations that the surgeon feels are not amenable to internal fixation using INFIX, with or without adjunctive ilio-sacral screws

Courtesy telephone call/pos-card sub-study:
There are no additional exclusion criteria for the courtesy telephone call sub-study

Recruitment start date

02/08/2019

Recruitment end date

31/03/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Barts Health NHS Trust
The Royal London Hospital Whitechapel
London
E1 1BB
United Kingdom

Trial participating centre

North Bristol NHS Trust
Southmead Hospital Southmead Road Westbury-on-Trym
BRISTOL
BS10 5NB
United Kingdom

Trial participating centre

Cambridge University Hospitals NHS Foundation Trust
Addenbrookes Hospital Hills Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

King's College Hospital NHS Foundation Trust
Denmark Hill
London
SE5 9RS
United Kingdom

Trial participating centre

Brighton and Sussex University Hospitals NHS Trust
Royal Sussex County Hospital Eastern Road
Brighton
BN2 5BE
United Kingdom

Trial participating centre

Oxford University Hospitals NHS Foundation Trust
John Radcliffe Hospital Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

South Tees Hospitals NHS Foundation Trust
James Cook University Hospital Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

NHS Lothian
Waverley Gate 2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom

Trial participating centre

Sheffield Teaching Hospitals NHS Foundation Trust
Northern General Hospital Herries Road
Sheffield
S5 7AU
United Kingdom

Trial participating centre

Cardiff & Vale University LHB
Corporate Headquarters Heath Park
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Plymouth Hospitals NHS Trust
Derriford Hospital Derriford Road
Plymouth
PL6 8DH
United Kingdom

Trial participating centre

Hull and East Yorkshire Hospitals NHS Trust
Hull Royal Infirmary Anlaby Road
Hull
HU3 2JZ
United Kingdom

Trial participating centre

University Hospitals Coventry and Warwickshire NHS Trust
Walsgrave General Hospital Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Trial participating centre

Leeds Teaching Hospitals NHS Trust
St James's University Hospital Beckett Street
Leeds
LS9 7TF
United Kingdom

Trial participating centre

University Hospital Southampton NHS Foundation Trust
Mailpoint 18 Southampton General Hospital Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Aintree University Hospital NHS Foundation Trust
University Hospital Aintree Fazakerley Hospital Lower Lane
Liverpool
L9 7AL
United Kingdom

Trial participating centre

NHS Greater Glasgow and Clyde
J B Russell House Gartnavel Royal Hospital 1055 Great Western Road
Glasgow
G12 0XH
United Kingdom

Trial participating centre

St George's University Hospitals NHS Foundation Trust
St George's Hospital Blackshaw Road Tooting
London
SW17 0QT
United Kingdom

Trial participating centre

Imperial College Healthcare NHS Trust
St. Marys Hospital Praed Street
London
W2 1NY
United Kingdom

Trial participating centre

Nottingham University Hospitals NHS Trust
Trust Headquarters Queens Medical Centre Derby Road
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

University Hospitals Birmingham NHS Foundation Trust
Trust HQ, PO Box 9551 Queen Elizabeth Medical Centre Edgbaston
Birmingham
B15 2TH
United Kingdom

Trial participating centre

University Hospitals Of North Midlands NHS Trust
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom

Trial participating centre

Salford Royal NHS Foundation Trust
Salford Royal Stott Lane
Salford
M6 8HD
United Kingdom

Trial participating centre

Portsmouth Hospitals NHS Trust
De La Court House Queen Alexandra Hospital Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom

Sponsor information

Organisation

Barts Health NHS Trust

Sponsor details

The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
+44 (0)207 043 0734
research.governance@qmul.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 16/167/57

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Peer-reviewed scientific journals
2. Internal report
3. Conference presentation
4. Publication on website
5. Other publication
6. A letter will be sent to participants at the end of the study thanking them for their involvement and providing them with a short summary of the results
7. Additional files will be made available via the HTA website

IPD sharing statement
The datasets generated during and/or analysed during the current study (fully anonymised) will be available upon request after the publication of the study results from Prof. David Torgerson (David.Torgerson@york.ac.uk).

Intention to publish date

31/03/2024

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/04/2020: Due to current public health guidance, recruitment for this study has been paused. 04/09/2019: The following changes were made to the trial record: 1. The ethics approval was added. 2. The recruitment start date was changed from 01/05/2019 to 02/08/2019. 05/07/2019: Internal review.