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  • 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)

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Surgery
Protocol
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)
  1. D P ter Meulen1,2,
  2. M A M Mulders3,
  3. A A Kruiswijk1,
  4. E J Kret1,
  5. M E Slichter4,
  6. J M van Dongen5,
  7. G M M J Kerkhoffs6,
  8. J C Goslings7,
  9. Y V Kleinlugtenbelt8,
  10. N W Willigenburg1,
  11. N W L Schep9,
  12. R W Poolman1,2
  13. DART Study Group
    1. 1Orthopedic Surgery, OLVG, Amsterdam, The Netherlands
    2. 2Orthopedic Surgery, LUMC, Leiden, The Netherlands
    3. 3Trauma Surgery, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands
    4. 4Orthopedic Surgery, Reinier de Graaf Hospital, Delft, The Netherlands
    5. 5Department of Health Sciences, Faculty of Science, and the Amsterdam Movement Sciences Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
    6. 6Orthopedic Surgery, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands
    7. 7Trauma Surgery, OLVG, Amsterdam, The Netherlands
    8. 8Orthopedic Surgery, Deventer Ziekenhuis, Deventer, The Netherlands
    9. 9Trauma Surgery, Maasstad Ziekenhuis, Rotterdam, The Netherlands
    1. Correspondence to Drs D P ter Meulen; d.termeulen{at}olvg.nl

    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).

    • clinical trials
    • orthopaedic & trauma surgery
    • hand & wrist
    • musculoskeletal disorders
    • trauma management
    http://creativecommons.org/licenses/by-nc/4.0/

    This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

    http://dx.doi.org/10.1136/bmjopen-2021-051658

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      Footnotes

      • Collaborators BA Twigt (BovenIJ Hospital, Amsterdam); AH van der Veen (Catharina Hospital, Eindhoven); GJP Smits (Catharina Hospital, Eindhoven); ER Flikweert (Deventer Hospital, Deventer); EBM Landman (Deventer Hospital, Deventer); EJMM Verleisdonk (Diakonessenhuis, Utrecht); KWW Lansink (Elisabeth Tweesteden Hospital, Tilburg); T Gosens (Elisabeth Tweesteden Hospital, Tilburg; Tilburg University; Center of Research on Psychological and Somatic disorders (CoRPS); Department of Medical and Clinical Psychology); JW Colaris (ErasmusMC, Rotterdam); BA van Dijkman (Flevoziekenhuis, Almere); AJ Dijkstra (Flevoziekenhuis, Almere); M Rutgers (HAGA Hospital, Den Haag); RG Zuurmond (Isala Clinics, Zwolle); SH van Helden (Isala Clinics, Zwolle); MCQ Steinweg (Isala Clinics, Zwolle); N Oerlemans (Isala Clinics, Zwolle); BC van der Zwaard (Jeroen Bosch Hospital, Den Bosch); S Romijn (Jeroen Bosch Hospital, Den Bosch); RJP van der Wal (LUMC, Leiden); J Vermeulen (Maasstad Hospital, Rotterdam); CA Selles (Maasstad Hospital, Rotterdam); PA Jawahier (Maasstad Hospital, Rotterdam); BI Cleffken (Maasstad Hospital, Rotterdam); D Haverkamp (Medisch Centrum Slotervaart, Amsterdam); AJ Vochteloo (OCON Orthopedic Clinic, Hengelo); R Huis in 't Veld (OCON Orthopedic Clinic, Hengelo); RN van Veen (OLVG, Amsterdam); HR van den Berg (OLVG, Amsterdam); R Haverlag (OLVG, Amsterdam); MP Simons (OLVG, Amsterdam); A Rasker (OLVG, Amsterdam); JPM Frölke (Radboud University Medical Center, Nijmegen); GA Kraan (Reinier de Graaf Hospital, Delft); NMC Mathijssen (Reinier de Graaf Hospital, Delft); MR de vries (Reinier de Graaf Hospital, Delft); N Sosef (Spaarne Gasthuis); A van Noort (Spaarne Gasthuis); IN Sierevelt(Spaarne Gasthuis, Xpert Clinics, Orthopedic department, Specialized Centre of Research and Education (SCORE), Amsterdam).

      • Contributors DPtM, MM, AK, EK, MES, JMvD, GMMJK, JCG, YK, NW, NWLS, RWP all participated in the design of the study. They revised the protocol paper critically and approved the submitted manuscript. DPtM, JMvD, NW and RWP contributed substantially on the development of the data analysis plan. The contributors: BAT, AHvdV, GJPS, ERF, EBML, EJMMV, KWWL, TG, JWC, BAvD, AJD, MR, RGZ, SHvH, MCQS, NO, BCvdZ, SR, RJPvdW, JV, CAS, PJ, BIC, DH, AJV, MHAHitV, RNvV, HRvdB, RH, MPS, AR, JPMF, GK, NMCM, MRdV, NS, AvN, INS all revised the protocol paper. They substantially contribute to the collection of data and approved this manuscript.

      • Funding This trial is supported by the Dutch Organisation for Health Research and Development (ZonMw grant number 80-83700-98-16501) and the association for Dutch healthcare insurers (Zorgverzekeraars Nederland).

      • Competing interests None declared.

      • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

      • Provenance and peer review Not commissioned; externally peer reviewed.