Cost-effectiveness of on-demand removal of syndesmotic screws.

PURPOSE: Syndesmotic screw removal following acute syndesmotic injury is a commonly performed procedure. However, recent studies suggest that the removal does not result in improved patient reported outcome, while the procedure has proved not to be without complications. The aim of this study was to present a health-economic evaluation of on-demand removal (ODR) compared to routine removal (RR) of the syndesmotic screw. METHODS: Data were collected from the RODEO trial, a randomized controlled non-inferiority trial comparing functional outcome of ODR with RR. Economic evaluation resulted in total costs, costs (in Euro) per quality adjusted life year (QALY) and costs per point improvement on the Olerud Molander Ankle Score (OMAS). This included both direct and indirect costs. RESULTS: Total costs for ODR were significantly lower with a mean difference of 3160 euro compared to RR (p < 0.001). The difference in QALY was not significant. The difference in OMAS at 12 months was 1.79 with an incremental cost-effectiveness ratio (ICER) of €-1763 (p = 0.512). The ICER was well below the willingness to pay. Although unit costs might vary between hospitals and countries, these results provide relevant data of cost-effectiveness. CONCLUSION: The clinical effectiveness of both ODR and RR can be considered equal. The costs are lower for patients treated with ODR, which leads to the conclusion that ODR is cost-effective.

Volar Plate Fixation Versus Cast Immobilization in Acceptably Reduced Intra-Articular Distal Radial Fractures: A Randomized Controlled Trial.

BACKGROUND: The evidence for the treatment of acceptably reduced intra-articular distal radial fractures remains inconclusive. We therefore compared the functional outcomes of cast immobilization (nonoperative) and volar plate fixation (operative) for patients with these fractures. METHODS: This multicenter randomized controlled trial enrolled patients between 18 and 75 years old with an acceptably reduced intra-articular distal radial fracture. Patients were randomized to nonoperative treatment or to operative treatment. The primary outcome measure was the Patient-Rated Wrist Evaluation (PRWE) score after 12 months. Secondary outcome measures were the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire; the Short Form-36 (SF-36) questionnaire; a visual analog scale for pain; range of motion; grip strength; radiographic parameters; and complications. Analyses followed the intention-to-treat principle. RESULTS: A total of 96 patients were randomized, and 90 (46 in the nonoperative group and 44 in the operative group) were included in the analysis. Patients treated in the operative group had significantly better functional outcomes measured with the PRWE at 6 weeks, 3 months, 6 months, and 1 year. Additionally, a 28% rate of subsequent surgery was identified in the nonoperative group. CONCLUSIONS: Adult patients with an acceptably reduced intra-articular distal radial fracture have better functional outcomes for 12 months when treated operatively instead of nonoperatively. We therefore recommend surgical treatment for patients with these fractures. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Correction to: Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial).

An amendment to this paper has been published and can be accessed via the original article.

Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial).

BACKGROUND: Syndesmotic injuries are common and their incidence is rising. In case of surgical fixation of the syndesmosis a metal syndesmotic screw is used most often. It is however unclear whether this screw needs to be removed routinely after the syndesmosis has healed. Traditionally the screw is removed after six to 12 weeks as it is thought to hamper ankle functional and to be a source of pain. Some studies however suggest this is only the case in a minority of patients. We therefore aim to investigate the effect of retaining the syndesmotic screw on functional outcome. DESIGN: This is a pragmatic international multicentre randomised controlled trial in patients with an acute syndesmotic injury for which a metallic syndesmotic screw was placed. Patients will be randomised to either routine removal of the syndesmotic screw or removal on demand. Primary outcome is functional recovery at 12 months measured with the Olerud-Molander Score. Secondary outcomes are quality of life, pain and costs. In total 194 patients will be needed to demonstrate non-inferiority between the two interventions at 80% power and a significance level of 0.025 including 15% loss to follow-up. DISCUSSION: If removal on demand of the syndesmotic screw is non-inferior to routine removal in terms of functional outcome, this will offer a strong argument to adopt this as standard practice of care. This means that patients will not have to undergo a secondary procedure, leading to less complications and subsequent lower costs. TRIAL REGISTRATION: This study was registered at the Netherlands Trial Register (NTR5965), Clinicaltrials.gov ( NCT02896998 ) on July 15th 2016.

Delayed diagnosis of injury in survivors of the February 2009 crash of flight TK 1951.

INTRODUCTION: On 25th February 2009, a Boeing 737 crashed nearby Amsterdam, leaving 126 victims. In trauma patients, some injuries initially escape detection. The aim of this study was to evaluate the incidence of Delayed Diagnosis of Injury (DDI) and the tertiary survey on the victims of a plane crash, and the effect of ATLS(®) implementation on DDI incidence. PATIENTS AND METHODS: Data from all victims were analysed with respect to hospitalisation, DDI, tertiary survey, ISS, Glasgow Coma Score (GCS), injuries (number and type) and emergency intervention. Clinically significant injuries were separated from non-clinically significant injuries. The data were compared to a plane crash in the UK (1989), which occurred before ATLS(®) became widely practiced. RESULTS: All 126 victims of the Dutch crash were evaluated in a hospital; 66 were hospitalised with a total of 171 clinically significant injuries. Twelve (7%) clinically significant DDIs were found in 8 patients (12%). In 65% of all patients, a tertiary survey was documented. The incidence of DDI in patients with an ISS ≥ 16 (n=13) was 23%, vs. 9% in patients with ISS <16. Patients with >5 injuries had a DDI incidence of 25%, vs. 12% in patients with ≤ 5 injuries. Head injury patients had a DDI incidence of 19%, patients without head injury 10%. Fifty percent of patients who needed an emergency intervention (n=4) had a DDI; 3% of patients who did not need emergency intervention. Eighty-one survivors of the UK crash had a total of 332 injuries. DDIs were found in 30.9% of the patients. Of all injuries 9.6% was a DDI. The incidence of DDI in patients with >5 injuries was 5%, vs. 8% in those with ≤ 5 injuries. CONCLUSION: DDI in trauma still happen. In this study the incidence was 7% of the injuries in 12% of the population. In one third of the patients no tertiary survey was documented. A high ISS, head injury, more than 5 injuries and an emergency intervention were associated with DDI. The DDI incidence in our study was lower than in victims of a previous plane crash prior to ATLS implementation.