Abstract
BackgroundMortality following hip hemiarthroplasty is in the range of 10-40% in the first year, with much attributed to post-operative complications. One such complication is surgical site infection (SSI), which at the start of this trial affected 4.68% of patients in the UK having this operation. Compared to SSI rates of elective hip surgery, at less than 1%, this figure is elevated. The aim of this quasi randomised controlled trial (RCT) is to determine if high dose antibiotic impregnated cement can reduce the SSI in patients at 12-months after hemiarthroplasty for intracapsular fractured neck of femur.Methods848 patients with an intracapsular fractured neck of femur requiring a hip hemiarthroplasty are been recruited into this two-centre double-blind quasi RCT. Participants were recruited before surgery and quasi randomised to standard care or intervention group. Participants, statistician and outcome assessors were blind to treatment allocation throughout the study. The intervention consisted of high dose antibiotic impregnated cement consisting of 1 gram Clindamycin and 1 gram of Gentamicin. The primary outcome is Health Protection Agency (HPA) defined deep surgical site infection at 12 months. Secondary outcomes include HPA defined superficial surgical site infection at 30 days, 30 and 90-day mortality, length of hospital stay, critical care stay, and complications.DiscussionLarge randomised controlled trials assessing the effectiveness of a surgical intervention are uncommon, particularly in the speciality of orthopaedics. The results from this trial will inform evidence-based recommendations for antibiotic impregnated cement in the management of patients with a fractured neck of femur undergoing a hip hemiarthroplasty. If high dose antibiotic impregnated cement is found to be an effective intervention, implementation into clinical practice could improve long-term outcomes for patients undergoing hip hemiarthroplasty.Trial registrationCurrent Controlled Trials: ISRCTN25633145
Highlights
Mortality following hip hemiarthroplasty is in the range of 10-40% in the first year, with much attributed to post-operative complications
In this pragmatic trial setting, inclusion criteria stated any patient with an intracapsular fractured neck of femur deemed suitable for a hip hemiarthroplasty and the only exclusion criterion is that patients must not be under 18 years of age
In order to explore generalisability anonymised data about age and gender was recorded for all eligible patients
Summary
The Fractured Hip Infection Trial (FHIT) is an on-going two-centre double blind quasi-randomised controlled trial conducted at Northumbria NHS Foundation Trust, one of the largest elective orthopaedic centres in the UK. Both units undertake surgery with >95% of these patients undergoing surgery within 48 hours (NHFD report 2012), with timely surgery being incentivised by payments of £1335 per patient [5] This approach ensured the surgeon had little capacity to influence participant treatment allocation. A more optimal conventional randomisation methodology, that is randomly allocating individual study participants to one of the two treatment groups at recruitment, was not possible for this study It was decided by the study development team that it would not be feasible or practical to attempt to do this in the selected setting. Risks No additional risks for study patients were expected, since all surgical procedures carried out within FHIT represent clinically established standard methods of treatment of fractured neck of femur. SSI that occurs within 30 days of surgery, involves only the skin or subcutaneous tissue of the incision & meets at least one of the following criteria: SSI involving the deep tissues (i.e. fascial & muscle layers), within 30 days of surgery (or 1 year if an implant is in place) and the infection appears to be related to the surgical procedure & meets at least one of the following criteria: 1. Purulent drainage from superficial incision
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
