Effectiveness and cost-effectiveness of surgery versus casting for elderly patients with Displaced intra-Articular type C distal Radius fractures: protocol of a randomised controlled Trial with economic evaluation (the DART study). Issue 4 (1st April 2022)

• Record Type: Journal Article
• Authors: ter Meulen, D P; Mulders, M A M; Kruiswijk, A A; Kret, E J; Slichter, M E; van Dongen, J M; Kerkhoffs, G M M J; Goslings, J C; Kleinlugtenbelt, Y V; Willigenburg, N W; Schep, N W L; Poolman, R W
• Other Names: author non-byline.; Twigt BA author non-byline.; van der Veen AH author non-byline.; Smits GJP author non-byline.; Flikweert ER author non-byline.; Landman EBM author non-byline.; Verleisdonk EJMM author non-byline.; Lansink KWW author non-byline.; Gosens T author non-byline.; Colaris JW author non-byline.; van Dijkman BA author non-byline.; Dijkstra AJ author non-byline.; Rutgers M author non-byline.; Zuurmond RG author non-byline.; van Helden SH author non-byline.; Steinweg MCQ author non-byline.; Oerlemans N author non-byline.; van der Zwaard BC author non-byline.; Romijn S author non-byline.; van der Wal RJP author non-byline.; Vermeulen J author non-byline.; Selles CA author non-byline.; Jawahier PA author non-byline.; Cleffken BI author non-byline.; Haverkamp D author non-byline.; Vochteloo AJ author non-byline.; Huis In 't Veld R author non-byline.; van Veen RN author non-byline.; van den Berg HR author non-byline.; Haverlag R author non-byline.; Simons MP author non-byline.; Rasker A author non-byline.; Frölke JPM author non-byline.; Kraan GA author non-byline.; Mathijssen NMC author non-byline.; de vries MR author non-byline.; Sosef N author non-byline.; van Noort A author non-byline.; Sierevelt IN author non-byline.;
• Is Part Of: BMJ open. Volume 12:Issue 4(2022)
• Publication Date: 2022-04-01
• Subjects: clinical trials -- orthopaedic & trauma surgery -- hand & wrist -- musculoskeletal disorders -- trauma management; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2021-051658
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: Current literature is inconclusive about the optimal treatment of elderly patients with displaced intra-articular distal radius fractures. Cast treatment is less invasive and less expensive than surgical treatment. Nevertheless, surgery is often the preferred treatment for this common type of distal radius fracture. Patients with a non-acceptable position after closed reduction are more likely to benefit from surgery than patients with an acceptable position after closed reduction. Therefore, this study aims to assess non-inferiority of functional outcomes after casting versus surgery in elderly patients with a non-acceptable position following a distal radius fracture. Methods and analysis: This study is a multicentre randomised controlled trial (RCT) with a non-inferiority design and an economic evaluation alongside. The population consists of patients aged 65 years and older with a displaced intra-articular distal radius fracture with non-acceptable radiological characteristics following either inadequate reduction or redisplacement after adequate reduction. Patients will be randomised between surgical treatment (open reduction and internal fixation) and non-operative treatment (closed reduction followed by cast treatment). We will use two age strata (65–75 and >75 years of age) and a web-based mixed block randomisation. A total of 154 patients will be enrolled and evaluated with the patient-rated wrist evaluation as the primary outcome at 1-year follow-up. Secondary outcomes include the Disabilities of the Arm, Shoulder and Hand questionnaire, quality of life (measured by the EQ-5D), wrist range of motion, grip strength and adverse events. In addition, we will perform a cost-effectiveness and cost-utility analysis from a societal and healthcare perspective. Incremental cost-effectiveness ratios, cost-effectiveness planes and cost-effectiveness acceptability curves will be presented. Ethics and dissemination: The Research and Ethics Committee approved this RCT (NL56858.100.16). The results of this study will be reported in a peer-reviewed journal. We will present the results of this study at (inter)national conferences and disseminate the results through guideline committees. Trial registration number: Clinicaltrials.gov (NCT03009890 ). Dutch Trial Registry (NTR6365).