Aims: A pragmatic multicentre non-inferiority randomised controlled trial (SOFFT) was conducted in Major Trauma Centres (MTCs) and Trauma Units across the United Kingdom (UK) to investigate the clinical and cost-effectiveness of tension suture repair (TSR) compared to tension band wiring (TBW) surgery for the fixation of acute Mayo IIA olecranon fractures in adult patients. Methods: A within-trial economic evaluation was undertaken from the National Health Service (NHS) and Personal Social Services (PSS) perspective. Health care resource use and EQ-5D-5L utility was measured at baseline, 4-month, 12-month and 18-month follow-up for primary analysis. Missing data was imputed via multiple imputation with chained equations. The incremental cost-effectiveness ratio (ICER) was calculated with seemingly unrelated regression and the uncertainty was handled by non-parametric bootstrapping. Sensitivity analyses were performed to assess the robustness of primary findings. An exploratory subgroup analysis was conducted to examine the heterogeneity in cost-effectiveness between participants aged ≥50 years and <50 years at baseline. Results: Compared to TBW, TSR led to £969 (95%CI -£2,599 to £661) cost-savings per participant but provided 0.02 fewer QALYs (95%CI -0.08 to 0.03). The probability of TSR being cost-effective ranged from 57% to 73% under the cost-effectiveness thresholds between £15,000 and £30,000. The findings were robust to most sensitivity analyses. The exploratory subgroup analysis indicated that TSR was cost-effective in both age groups, with TSR potentially being dominant among participants aged <50 years. Using current data on the incidence of this fracture type, replacing TBW with TSR could potentially lead to £5 million annual savings for the NHS, although this estimate is subject to uncertainty and should be interpreted with caution. Conclusion: TSR is likely to be cost-effective compared to TBW for the fixation of adult patients (≥16 years) with an acute Mayo IIA olecranon fracture.
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)