ateral compression type-1 fracture fixation in the elderly, a randomised controlled trial

Barts Health NHS Trust0 个研究点目标入组 11 人开始时间: 2019年4月8日最近更新: 2024年4月8日

适应症

试验速览

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)

•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

•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

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