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Lateral Compression Type-1 fracture fixation in the elderly, a randomised controlled trial (L1FE)

We aimed to evaluate fracture fixation for patients with a lateral compression type-1 pelvic fracture. However, fewer older patients with the fracture were identified than expected and Covid restrictions made it difficult to discuss the study with patients and families. We were therefore unable to recruit sufficient people into the study so it closed early. 

Why did we do this research?

Lateral compression type-1, a specific type of pelvic fracture, can heal without surgery; patients are offered pain relief and encouraged to move as much as they can after the injury. These fractures can be painful, and some people are not able to get up and walk for weeks. Such fractures can cause health problems like chest or  urinary tract infections, pressure sores and blood clots. Pelvic surgeons think patients with this fracture may benefit from surgery with an internal fixation device (a bar and screws) to stabilise the pelvis.

What did we do?

We aimed to find out which treatment is better for patients and better value for money for the NHS by doing a randomised controlled trial. This required 600 people aged over 60, in hospital with a pelvic fracture and having difficulty walking to take part. Three hundred 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.

What did we find?

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 and therefore were not eligible to be included in the study. Of the remaining patients, 13.6% were eligible and 30.6% of those consented to take part. Restrictions on visitors during the coronavirus disease 2019 pandemic made it difficult to discuss the study with patients’ families and fewer patients were admitted to hospital where the study was taking place. Our research question could not be answered by this study at the present time.

Publications

  • Cook E, Laycock J, Sivapathasuntharam D, Maturana C, Hilton C, Doherty L, et al. Surgical versus non-surgical management of lateral compression type-1 pelvic fracture in adults 60 years and older: the L1FE RCT. Health Technol Assess 2024;28(15) https://doi.org/10.3310/LAPW3412
  • Booth A, Ingoe HMA, Northgraves M, et alEffectiveness of surgical fixation for lateral compression type one (LC-1) fragility fractures of the pelvis: a systematic reviewBMJ Open 2019;9:e024737. doi:10.1136/bmjopen-2018-024737 https://bmjopen.bmj.com/content/9/5/e024737

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Trial Details

Funder

National Institute for Health Research Health Technology Assessment Programme (16/167/57)

Sponsor
Barts Health NHS Trust

ISRCTN registration
This trial is registered as ISRCTN16478561

IRAS project number
255609

Ethics Committee & Reference Number

London – Harrow REC (Ref: 19/LO/0555) 

Scotland A REC (REF 21/SS/0002)

Start Date
01.10.2018

End date
31.03.2023

YTU Team

External Collaborators

  • Peter Bates, Chief Investigator, Barts Health NHS Trust
  • Jamila Kassam, Barts Health NHS Trust
  • Catherine Hilton, Barts Health NHS Trust
  • Dhanupriya Sivapathasuntharam, Barts Health NHS Trust
  • Peter Hull, Nottingham University Hospital NHS Trust
  • Mehool Acharya, North Bristol NHS Trust
  • Daren Forward, Nottingham University Hospital NHS Trust

Information for site staff 

https://youtu.be/PxwinQLzI3E

https://youtu.be/qKa6U_4lRSY

https://youtu.be/cepfRBUMkdE