Cemented compared to uncemented femoral stems in total hip replacement for displaced femoral neck fractures in the elderly: study protocol for a single-blinded, randomized controlled trial (CHANCE-trial)

摘要

Background Total hip replacement (THR) is the preferred method for the active and lucid elderly patient with a displaced femoral neck fracture (FNF). But controversy still exists regarding using cemented or uncemented stem in these patients. The aim of this study is to compare a cemented and uncemented femoral stem in patients 65–79?years treated surgically with THR for displaced FNF. Methods/design In a single-centre, single-blinded, randomized controlled trial, we will include 140 patients aged 65-79 years with an acute displaced FNF and randomize them in a 1:1 ratio to a cemented tapered or a uncemented tapered hydroxyapatite - coated femoral stem. A?cemented cup will be used in both groups. The patients will be blinded for allocation. The primary endpoints will be the incidence of all hip-related complications and health-related quality of life evaluated with EuroQol-5D (EQ-5D) index up to 2?years after surgery. Secondary outcomes will be overall mortality, general medical complications and hip function. The follow-up will be at 3?months, 1 and 2?years. Further follow-ups after end of study will be at 4 and 10?years. Results will be analysed using 95?% CI’s for the effect size. A regression model will also be used to adjust for stratification factor. Discussion The ethical committee at Karolinska Institutet has approved the study. An interim analysis on the primary endpoints will be performed when half the sample size is included. The results from the study will be disseminated to the medical community via presentations and publications in relevant medical journals. The study will provide evidence if a cemented or uncemented femoral stem is preferable in THR for elderly patients with a displaced FNF. Trial registration The trial is registered at clinicaltrials.gov ( NCT02247791 ), October 21, 2013.