Title: A feasibility study to compare contemporary un-cemented hemiarthroplasty with the standard-of-care cemented hemiarthroplasty for the treatment of displaced intracapsular hip fractures
Funder: Department of Health and Social Care

Abstract: Background Hip fracture represents one of the biggest challenges facing patients and healthcare systems. Worldwide there are 1.3 million hip fractures and more than 70,000 in the UK every year.(3) These figures are projected to rise to >100,000 by 2020 in the UK(3)and to more than 6 million by 2050 worldwide.(4) The global cost of this clinical problem is estimated at 1.75 million disability adjusted life years lost and represents 1.4% of the total healthcare burden in established market economies.(5) Despite the scale and severity of the problem there remains uncertainty about the use of bone cement in the largest subgroup of hip fracture patients, those with a displaced intracapsular fracture. Registry studies have shown increased perioperative morbidity and mortality associated with cement.(6) Despite these concerns, our national guidelines recommend the use of cement. This is because the bulk of the evidence(7) reports inferior functional outcomes associated with first generation un-cemented implants. These implants have now been superceded by contemporary (third generation) implants. The evidence base for these contemporary implants is limited and as yet there has not been a large multicentre randomised controlled trial to evaluate their effectiveness. This work aims to address this gap in the evidence and has the potential to make hip fracture surgery safer and more cost-effective. Aim To inform the design of a pragmatic multicentre randomised controlled trial of un-cemented hemiarthroplasty versus the standard-of-care cemented hemiarthroplasty in patients with a displaced intracapsular hip fracture. Research question In patients over 60 years of age with a displaced intracapsular hip fracture, is there a difference in health-related quality of life at 4-months post surgery between a contemporary un-cemented hemiarthroplasty and the current standard-of-care cemented hemiarthoplasty? Objectives 1) To establish the rate of recruitment in the context of a multi-centre pilot pragmatic trial. 2) To assess the distribution of observed differences in the patients health-related quality of life between the trial treatment groups at four months post-injury, in order to inform the sample size calculation for a full scale RCT. 3) To inform the delivery of the two interventions in the context of a clinical trial. 4) To evaluate willingness of clinicians to recruit participants (the proportion of eligible patients who are offered participation in the study). Methods & Analysis This will be a three-centre, multi-surgeon, two-arm, standard-of-care pilot randomised controlled trial. The pilot is expected to last 18 months and recruit 100 participants. All patients over 60 years of age, both with and without capacity, with a displaced intracapsular hip fracture treated with hemi-arthroplasty are eligible. Participant outcomes will be recorded at baseline (a retrospective pre-injury status) and at 30, and 120 days. The primary outcome measure is the EuroQol-5D-5L, a generic health related quality of life outcome tool. Secondary outcomes will include mortality, Oxford Hip Score (in patients with capacity), length of hospital stay, operative time, and related complications. The analysis will inform the design of a multi-centre randomised trial. The results and consequent trial design will be presented and discussed at a collaborators meeting, with representation from potential collaborating centres, trial methodologists and the patient and public members. Benefits to patients Resolving the question of whether to use bone cement for hip fracture surgery has now become a priority since the publication of a National Patient Safety Agency (NPSA) alert which identified a number of deaths and cases of serious harm associated with the use of cement.(8) This work will determine if these risks could be completely avoided by evaluating the effectiveness of contemporary un-cemented implants. In addition, un-cemented surgery may be quicker and cheaper than when using cement.

Lay abstract: Should hip fracture implants be cemented? Hip fracture is a serious injury which mostly occurs in older patients. In the UK there are more than 70,000 hip fractures every year. A hip fracture is a potentially catastrophic event; approximately 30% of patients will die during the first year following this injury and those that survive will have a significant reduction in their quality of life. The most common type of hip fracture is treated with a partial hip replacement or hemi-arthroplasty . The hemi-arthroplasty can be fixed to the patient s thigh bone with or without the use of bone cement . Cement is the current standard technique, but there are some risks with bone cement which could be avoided by using un-cemented implants. These risks prompted a recent alert from the National Patient Safety Agency. However, traditionally the outcomes with the early types (first generation) of un-cemented implants were inferior to the cemented implants currently used. Since these studies were done, there have been significant improvements in un-cemented implant technology and the current, limited evidence suggests that these modern (contemporary) implants may be as good as the cemented implants but without the risks of using cement. The research needed is a trial to compare cemented with uncemented hemi-arthroplasty implants. In order to find out which type of implant is better for patients with hip fracture, we first need to undertake a smaller pilot study. This will establish the feasibility of running such a trial and gain vital data to determine how many participants we will need to recruit in the full trial to answer this important research question.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: INJURIES AND ACCIDENTS