Surgical versus conservative treatment of LC1 pelvic fractures in the elderly

Not Applicable

Completed

• Conditions: ateral compression type-1 pelvic fracture; Injury, Occupational Diseases, Poisoning; Fracture of lumbar spine and pelvis

• Registration Number: ISRCTN16478561
• Lead Sponsor: Barts Health NHS Trust

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36732808/ (added 06/02/2023) 2024 Results article in https://doi.org/10.3310/LAPW3412 (added 28/03/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-08
• Study Completion: 2021-12-09
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Current inclusion criteria as of 26/03/2021:
1. Aged 60 years or older
2. LC-1 pelvic fracture arising from a low-energy fall from standing height or less
3. Patient unable to mobilise independently to a distance of around 3 m and back, due to pelvic pain (or perceived pelvic pain) 72 h after injury. Use of a walking aid and verbal guidance are permitted, however physical assistance is not.

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
_____

Previous 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

Exclusion Criteria

Current inclusion criteria as of 26/03/2021:
1. Surgery not able to be conducted 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 physical assistance to walk, prior to their injury (use of a walking aid is permitted)
4. Concomitant injury or poly-trauma that impedes mobilisation
5. Fracture configurations not amenable to internal fixation using INFIX, with or without ilio-sacral screws
6. Patients who test positive for COVID-19 within 72 h of admission (applicable only where testing is standard of care)

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

_____

Previous 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/postcard sub-study:
There are no additional exclusion criteria for the courtesy telephone call sub-study

Study & Design

• Study Type: Interventional
• Study Design: Not specified