Surgical versus conservative treatment of LC1 pelvic fractures in the elderly

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?
Barts Health NHS Trust (UK)

When is the study starting and how long is it expected to run for?
October 2018 to December 2021

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

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

Study website

Contact information

Mrs Liz Cook
Scientific

York Trials Unit
University of York
York
YO10 5DD
United Kingdom

ORCID ID	0000-0001-6902-0235
Email	liz.cook@york.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom
• Wales

Study participating centres

Sponsor information

Barts Health NHS Trust
Hospital/treatment centre

The Royal London Hospital
Whitechapel
London
E1 1BB
England
United Kingdom

Phone	+44 (0)207 043 0734
Email	research.governance@qmul.ac.uk
Website	http://www.bartshealth.nhs.uk/
"ROR"	https://ror.org/00b31g692

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

28/03/2024: Publication reference added.
06/02/2023: Publication reference added.
19/12/2022: The intention to publish date was changed from 30/06/2022 to 31/03/2023.
30/09/2021: The following changes have been made:
1. The recruitment end date has been changed from 31/03/2022 to 13/08/2021.
2. The overall trial end date has been changed from 31/03/2023 to 09/12/2021 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 31/03/2024 to 30/06/2022.
4. The final enrolment number has been added.
26/03/2021: The following changes have been made:
1. Recruitment has resumed as of 15/03/2021.
2. The ethics approval for Scotland has been added.
3. The IRAS number has been added.
4. The participant inclusion criteria have been changed.
5. The participant exclusion criteria have been changed.
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.