Title: AceFIT – Acetabular Fractures in older patients Intervention Trial. A feasibility study comparing three methods of treatment of acetabular fractures in older patients; surgical fixation versus surgical fixation and hip replacement versus non-surgical treatment.
Funder: Department of Health and Social Care

Abstract: Background Approximately 2,000 older people break the pelvic part of their hip joint (acetabulum) each year in the UK 13.14. This is a vulnerable patient group; pre-existing medical conditions are common, one year mortality is 25%23 and a recent study of older patients with similar fractures found that 30% have cognitive impairments2. Based on hip fracture data, we estimate that the annual cost to the NHS and society is over &pound;80 million10. Acetabular fractures are a type of hip fracture and occur in the same population group. NICE guidelines for the management of hip fractures state that patients should be allowed to fully weight bear immediately following treatment 10. There is no guidance in place for acetabular fractures with minimal evidence available to inform best practice. Currently, three treatment options (one non-surgical, two surgical). Non surgical treatment involves patients keeping their full weight of the affectect limb until the fracture has healed. The two types of surgical treatment are surgical fixation (SF) with a plate and screws or surgical fixation (plate and screws) combined with a hip replacement (SF + HR). Non surgical treatment and the first surgical treatment option (plate and screws) mean that patients are unable to weight bear fully on the affected limb for a prolonged period, with often concurrent underlying osteoporosis. This is difficult for older patients, especially those who are frail/cognitively impaired, thereby restricting their mobility and increasing the risk of complications and prolonging their dependence on care. It also contravenes NICE guidelines which advise that patients should immediately weightbear after treatment for a hip fracture to ensure the best outcome. The third treatment option is to replace the hip joint after fixation of the acetabular fracture, which is a strategy commonly employed after hip fracture. This allows immediate greater weightbearing, aligns care with NICE guidelines for hip fractures and potentially enables patients to return to function earlier.There is however potential side effects associated with this treatment option. Surgery is longer and implant costs (total hip replacement/plate and screws) are also signicantly more than the second treatment option (plate and screws alone). We are uncertain as to which of these treatments result in the best outcome for patients. All treatments have potential complications. Our aim is to assess the feasibility of performing a larger scale trial and if found to be feasible we will apply for HTA funding. Our objectives are to measure: Willingness of patients to participate and clinicians to recruit participants Drop out rates Ability to capture all data Inform the sample size calculation for the main trial Completion rates and main cost-drivers, to inform the decision how costs and benefits should be measured in a definitive trial Plan of investigation We are proposing a 5 centre trial to assess the above objectives. Inclusion criteria 1. Patients aged 60 years or over, including those with cognitive impairment 2. Sustaining an acetabular fracture, that the consultant surgeon considers may benefit from surgical treatment (fractures involving displacement of either anterior column, posterior column or quadrilateral plate, posterior wall with marginal impaction). All such patients could also be treated without surgery. Eligible and appropriately consented patients will be randomised to one of the three treatment options. Patient reported outcome measures will be collected using validated questionnaires, namely EQ-5D-5L,, Disability Rating Index (DRI) and the Oxford Hip Score (OHS). We will record complications, perioperative outcomes, qualitative outcomes, items of resource use and xray images. Data will be collected at baseline, 6 weeks, 6 and 9 months post-injury. Potential benefits If feasible, a definitive trial will assess the clinical and cost effectiveness of the three treatment options.

Lay abstract: Approximately 2,000 older people break the cup part of their hip (acetabulum) each year in the UK. These fractures are a challenge to treat in older patients as the bone is often fragile and in many pieces. There are three main treatment options bed rest until the fracture heals enough to allow some weight bearing surgery with repair of the fracture with a plate and screws to hold the fractured pieces together surgery where the hip joint is replaced along with a plate and screws Patients treated with bed rest or with the second option, a plate and screws, are not permitted to fully walk on their injured leg until their fracture has healed. Consequently these patients often have a prolonged recovery and may have a poorly functioning hip joint afterwards. Treatment with the third option, replacement of the hip joint along with a plate and screws, avoids the potential problem of a damaged hip joint in the long term and most positively enables patients to start walking on their injured leg immediately. The surgery however is longer and may be associated with more side effects. Currently we do not know which of these treatment is best and all have potential side effects. We propose to undertake a study comparing the treatments in older patients. Patients who have agreed to participate will be randomly allocated to one of three treatment groups; 20 patients receiving no surgery, 20 plate and screws and 20 plate and screws combined with a hip replacement. We will collect information from patients/carers about their health before their treatment and afterwards (including complications, health related questionnaires, costs and x-ray pictures) at 6 weeks, 6 months and 9 months after treatment. This will allow us to assess the possibility of comparing the treatments with a subsequent larger study.

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