L1FE: Lateral compression type-1 fracture fixation in the elderly
Research type
Research Study
Full title
Lateral compression type-1 fracture fixation in the elderly, a randomised controlled trial
IRAS ID
255609
Contact name
Peter Bates
Contact email
Sponsor organisation
Joint Research Management Office, Barts Health NHS Trust
Duration of Study in the UK
3 years, 5 months, 30 days
Research summary
Research Summary
Lateral Compression type-1 (LC-1) pelvic fractures occur when older adults with weak bones fall onto their side. We 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 to 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.
This randomised controlled trial will find out which treatment is better for patients. We will recruit 600 adults (aged over 60) from hospitals who have had an LC-1 fracture and are having difficulty walking. 300 will receive surgery with the INFIX and 300 will receive standard non-surgical treatment.
We will assess patients at the start of the study, then at two weeks, six weeks, 12 weeks, six months, and some participants at one year. Participants will complete a few questionnaires that our patient panel think are important, a walking assessment (at 12 weeks), and have x-rays to check healing at 12 weeks. We will also find out the cost of both treatments relative to its benefits to find out which is better value for money for the NHS.
Summary of Results
When older adults with weak bones fall onto their side they can fracture the pelvis in a certain way known as a ‘Lateral Compression Type-1 fracture’, this summary will use ‘pelvic fracture’ to describe the injury.
Pelvic fractures can heal without surgery, patients are offered pain relief and encouraged to move as much as they can after the injury. Pelvic fractures can be painful, some people are not able to get up and walk for several weeks. This can cause health problems such as chest infections, urinary tract infections, pressure sores, and blood clots. To avoid these problems, we are trying to find treatments to help people recover sooner. Pelvic surgeons think patients may benefit from surgery with an internal fixation device (a bar and screws) to stabilise the pelvis, however there can be risks and complications with any surgery.
This study aimed to find out which treatment is better for patients and better value for money for the NHS. This required 600 people aged over 60, in hospital with a pelvic fracture and having difficulty walking to take part. 300 would receive surgery and 300 would receive non-surgical treatment. Over 6 months, participants would complete questionnaires, a walking assessment, and have x-rays to check healing. The trial had a 12-month run-in period to see if enough people would take part.
The trial closed early as we were unable to recruit sufficient people into the study. Fewer older patients with pelvic fractures were identified than expected, 51% were able to walk after a few days therefore were not eligible to be included in the study. 13.6% of patients were eligible and 30.6% of those consented to take part. Restrictions on visitors during the COVID-19 pandemic made it difficult to discuss the study with patients’ families and fewer patients were admitted to hospital where the study was taking place.
The research question could not be answered by this study at the present time.
REC name
London - Harrow Research Ethics Committee
REC reference
19/LO/0555
Date of REC Opinion
16 Jul 2019
REC opinion
Further Information Favourable Opinion