Title: L1FE: Lateral Compression Type-1 Fracture Fixation in the Elderly, a Randomised Controlled Trial
Funder: Department of Health and Social Care

Abstract: DESIGN: We will undertake a multi-centre, randomised controlled superiority trial, with a 12 month internal pilot, to investigate the clinical and cost effectiveness of surgical fixation with INFIX compared to non-surgical management of Lateral Compression Type-1 (LC-1) fragility fractures in older adults. SETTING: NHS Major Trauma Centres and Trauma units where surgeons are experienced in performing these operations. TARGET POPULATION: Patients aged 60 years or over, with or without cognitive impairment who have a Lateral Compression Type-1 (LC-1) fracture due to low energy fall such as a fall from standing height, who are unable to mobilise (+/- a walking aid) for 6 metres at 3 days independently or with supervision. HEALTH TECHNOLOGIES ASSESSED: Surgical Fixation: Anterior pelvic fixation using INFIX surgical technique/device. Non-operative management: Non-surgical treatment in the control arm will receive UK standard of care, consisting of mobilisation as pain allows. In both treatment groups, patients will receive physiotherapy as per standard of care. Both groups will receive standardised written physiotherapy advice that details the exercises they need to perform. MEASUREMENT OF COSTS AND OUTCOMES: We will collect costs on both treatments (INFIX surgical intervention; time in hospital; rehabilitation). Cost-effectiveness will be measured in terms of cost per QALY in accordance with NICE guidance using regression methods. Consent to long term follow up using routinely collected data will be sought. OUTCOME MEASURES: The primary outcome measure is average patient quality of life over the study (up to 6 months) as assessed by EQ-5D-5L (EuroQol); secondary outcome measures are: Physical Function assessed by Patient Reported Outcome Measures Information System (PROMIS) and Timed Up and Go (TUG): Numeric Rating Scale (NRS) for pain: 4AT Rapid Assessment Test for Delirium: Abbreviated Mental Test Score (AMTS): Complications and adverse events: Fracture healing: Other outcomes: Length of hospital stay and other resource use; change of place of residence, and return to normal activities; mortality. SAMPLE SIZE: In order to detect a minimum clinically important difference of 0.074 in EQ-5D-5L utility scores (standard deviation 0.25) with 90% power, we need to analyse 480 participants (240 per group). Accounting for 20% attrition at the primary endpoint of six months post randomisation follow up, the total recruitment target is 600 participants (300 per arm). RANDOMISATION: Randomisation will be done by York Trials Unit's secure, web-based service to ensure allocation concealment. PROJECT TIMETABLE AND RECRUITMENT: Project duration 54 months: 0-6 setup; 7-18 recruit to internal pilot; 19-42 recruit to full trial; 43-48 final follow up; 49-54 analysis and reporting. Each of the 19 sites will recruit 1 patient a month from set up to 42 months. The 19 sites will be set up over months 7 to 15; six every three months, seven in the third quarter. EXPERTISE IN TEAM: Team members have expertise in surgical and non-surgical management of patients with LC-1 fractures; ortho-geriatrics; physiotherapy and rehabilitation; design, analysis and conduct of multi-centre orthopaedic surgical RCTs (including trials where surgery is being compared to non-surgical management), feasibility studies, statistics, health economics and experience of having treatment for this condition.

Lay abstract: Having a fracture can be life changing for many people; we are trying to find new treatments to help people have better outcomes. With age people have an increased risk of fracturing or breaking a bone. A common bone to fracture is the pelvis; this type of fracture is called a Lateral Compression type-1 (LC-1) fracture. These fractures often occur when older adults with weak bones because of osteoporosis fall from a standing height onto their side. This type of break or fracture is called a fragility fracture. Not all pelvic fractures are connected with osteoporosis, each fracture and cause of fracture is unique. As the UK and the world have an aging population there is expected be an increase in the number of people experiencing an LC-1 fracture. With more people having LC-1 fractures the cost of fragility fractures is expected to rise. The current treatment for LC-1 fractures is to encourage people to move as much as they can tolerate, as soon as possible after the injury. The reason LC-1 fractures are not treated with surgery was that until recently the hardware (screws and plates) used to fix and stabilise the fracture did not grip well in bones with osteoporosis. LC-1 fractures can be painful and some people are not able to get up and walk for weeks. Not getting up and moving (immobility) is associated with additional health problems such as chest infections, urinary tract infections, pressure sores, and blood clots. These additional health problems can contribute to loss of independence and difficulty coping at home; this can happen to anyone who is immobile (not limited to those with LC-1 fractures). With the help of physiotherapy and rehabilitation people are able to improve their strength, get back on their feet, and complete everyday activities. Pelvic surgeons think patients that have difficulty walking after an LC-1 fracture may benefit from a new surgical technique called the INFIX. This technique uses a long bar and screws to fix or stabilise the pelvis in the best position to heal. The screws are placed into the large hip bones, which even in someone with osteoporosis would have good grip. The INFIX may improve the treatment of these fractures and patients outcomes. The INFIX technique is safe, easy for surgeons to be trained in, and patients are able to move around quickly afterwards. Moving around quickly after surgery is important to help to prevent some of the complications associated with not moving. The patient panel we consulted with who they themselves have had fragility fractures think this new INFIX technique is worth exploring. However, as with all surgery, there can be risks and complications, particularly those associated with having a general anaesthetic. We understand older adults concern of having a general anaesthetic. The risk of having general anaesthetic in this study is the same as it would be for any other surgical procedure. This study is designed as a randomised controlled trial to find out which treatment: surgical fixation with the INFIX or standard non-surgical treatment is better for patients, and helps to save the NHS money. If people are able to get moving sooner after surgery compared to not having surgery this may help save money on rehabilitation, care, and help people get back to every day activities sooner. We will recruit older adults (60 years of age and above) who have had an LC-1 fracture resulting from a fall from standing height and are having difficulty walking because of pain from their injury. We aim to recruit 600 participants, 300 will receive surgical treatment with the INFIX and 300 will receive standard non-surgical treatment. Participants will be identified from hospital wards and clinics. We will seek written informed consent from patients. Our patient panel thought it was important to include people that have dementia as they will also be in pain and may have difficulty getting around. We agree with the patient panel and are including individuals with dementia in our study. If a patient cannot consent for themselves because of dementia their family, friend, or carer will provide agreement for the patient to participate on their behalf. 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. At the assessments participants will complete questionnaires about how they manage day to day activities, quality of life, any support they may have at home, complete a walking assessment (at 12 weeks), and have x-rays to check pelvis healing. All of our questionnaires have been chosen with help from our patient panel to be meaningful and not be a burden to complete. 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. The results of the study will be published in medical journals and presented at national and international conferences. We will ask patients who are part of our public panel to suggest ways we can publicise the results and communicate the findings to the public. Finally, we will work with the National Osteoporosis Society to publicise the results via their networks.

Research activity codes: 6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS