Lateral compression type-1 pelvic fracture Injury, Occupational Diseases, Poisoning Fracture of lumbar spine and pelvis
Conditions
Interventions
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 anter
Sponsors
Barts Health NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed