title: The effect of high dose antibiotic impregnated cement on rate of surgical site infection after hip hemiarthroplasty for fractured neck of femur: a protocol for a double-blind quasi randomised controlled trial.
abstract: BACKGROUND
  Mortality 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.
  
  
  METHODS
  848 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.
  
  
  CONCLUSIONS
  Large 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.
  
  
  BACKGROUND
  Current Controlled Trials: ISRCTN25633145.
authors.affiliation: Warwick Medical School, The University of Warwick, Coventry CV4 7AL, UK. a.p.sprowson@warwick.ac.uk.
authors.forename: Andrew P
authors.initials: AP
authors.lastname: Sprowson
authors.forename: Cyrus D
authors.initials: CD
authors.lastname: Jensen
authors.forename: Sanjay
authors.initials: S
authors.lastname: Gupta
authors.forename: Nick
authors.initials: N
authors.lastname: Parsons
authors.forename: Aradhyula N
authors.initials: AN
authors.lastname: Murty
authors.forename: Simon M G
authors.initials: SM
authors.lastname: Jones
authors.forename: Dominic
authors.initials: D
authors.lastname: Inman
authors.forename: Mike R
authors.initials: MR
authors.lastname: Reed
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001178:Arthroplasty; D001843:Bone Cements; D002985:Clinical Protocols; D004311:Double-Blind Method; D005265:Femoral Neck Fractures / Q000601:surgery*; D006801:Humans
chemical_list: D000900:Anti-Bacterial Agents; D001843:Bone Cements