title: WARRIOR-trial - is routine radiography following the 2-week initial follow-up in trauma patients with wrist and ankle fractures necessary: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Extremity fractures such as wrist and ankle fractures are a common and costly healthcare problem. The management of these fractures depends on fracture type and loss of congruity of the joint, resulting in cast immobilization or operative treatment. Loss of congruity or displacement leading to uneven joint loading, osteoarthritis and an increased probability of a poor functional outcome should be identified within the first 2 weeks post-trauma, based upon radiographs to determine optimal treatment. After this period, routine radiographs are scheduled for monitoring the bone-healing process. Current protocols describe imaging at 1, 2, 6 and 12 weeks post-trauma. However, it is questionable whether routine radiography following the initial follow-up ( 2-weeks post-trauma) is cost effective. The aim of this study is to determine whether a modification of the radiographic follow-up protocol can be conducted with no worse outcome and less cost than the current standard of care for patients with a wrist or ankle fracture.
  
  
  METHODS
  In a multicenter randomized controlled trial, 697 patients aged 18 years or older will be included: 385 wrist fracture- and 312 ankle fracture patients. Patients will be randomized into two groups: Group 1 receives usual care, consisting of radiographs 1, 2, 6 and 12 weeks post-trauma; Group 2 receives radiographs beyond the initial follow-up only when clinically indicated. The primary outcome is the overall extremity-specific function. For wrist fractures, this includes the Disabilities of the Arm, Shoulder and Hand Score; for the ankle fractures, this includes the Olerud and Molander ankle score. Secondary outcomes include: healthcare cost, the specific function measured with the Patient Rated Wrist and Hand Evaluation for wrist fractures and American Academy of Orthopaedic Surgeons foot and ankle questionnaire for ankle fractures, pain-intensity, health-related quality of life, self-perceived recovery, and complications. Both groups will be monitored at 1, 2, and 6 weeks and 3, 6, and 12 months.
  
  
  CONCLUSIONS
  This study will provide data on (cost) effectiveness of routine radiography in the follow-up of wrist and ankle fractures, and could pave the way for a change in (inter)national protocols.
  
  
  BACKGROUND
  Netherlands Trial Register NTR4610 , registration date 22 June 2014.
authors: Department of Surgery/Trauma Surgery, Leiden University Medical Centre, P.O. Box 9600, 2300 RC, Leiden, the Netherlands. n.l.weil@lumc.nl.
authors: Nikki L
authors: NL
authors: Weil
authors: Department of Surgery/Trauma Surgery, Leiden University Medical Centre, P.O. Box 9600, 2300 RC, Leiden, the Netherlands. m.f.termaat@lumc.nl.
authors: M Frank
authors: MF
authors: Termaat
authors: Department of Health Sciences, VU University Amsterdam, de Boelelaan 1085, 1081 HV, Amsterdam, the Netherlands. s.m.rubinstein@vu.nl.
authors: Sidney M
authors: SM
authors: Rubinstein
authors: Department of Surgery, University Medical Centre Groningen, P.O. Box 30.001, 9700 RB, Groningen, the Netherlands. m.el.moumni@umcg.nl.
authors: Mostafa
authors: M
authors: El Moumni
authors: Department of Surgery/Trauma Surgery, VU University Medical Centre Amsterdam, P.O. Box 7057, 1007 MB, Amsterdam, the Netherlands. w.zuidema@vumc.nl.
authors: Wietse P
authors: WP
authors: Zuidema
authors: Department of Surgery, Red Cross Hospital, P.O. Box 1074, 1940 EB, Beverwijk, the Netherlands. rderksen@rkz.nl.
authors: Robert Jan
authors: RJ
authors: Derksen
authors: Department of Surgery/Trauma Surgery, Leiden University Medical Centre, P.O. Box 9600, 2300 RC, Leiden, the Netherlands. p.krijnen@lumc.nl.
authors: Pieta
authors: P
authors: Krijnen
authors: Department of Medical Decision Making, Leiden University Medical Centre, P.O. Box 9600, 2300 RC, Leiden, the Netherlands. L.van_Bodegom-Vos@lumc.nl.
authors: Leti
authors: L
authors: van Bodegom-Vos
authors: Department of Surgery, University Medical Centre Groningen, P.O. Box 30.001, 9700 RB, Groningen, the Netherlands. k.w.wendt@umcg.nl.
authors: Klaus W
authors: KW
authors: Wendt
authors: Department of Radiology and Nuclear Medicine, VU University Medical Centre Amsterdam, P.O. Box 7057, 1007 MB, Amsterdam, the Netherlands. c.vankuijk@vumc.nl.
authors: Cornelis
authors: C
authors: van Kuijk
authors: Department of Clinical Epidemiology, Leiden University Medical Centre, P.O. Box 9600, 2300 RC, Leiden, the Netherlands. F.R.Rosendaal@lumc.nl.
authors: Frits R
authors: FR
authors: Rosendaal
authors: Department of Surgery/Trauma Surgery, Leiden University Medical Centre, P.O. Box 9600, 2300 RC, Leiden, the Netherlands. r.s.breederveld@lumc.nl.
authors: Roelf S
authors: RS
authors: Breederveld
authors: Trauma Unit, Academic Medical Centre, P.O. Box 22660, 1100 DD, Amsterdam, the Netherlands. j.c.goslings@amc.nl.
authors: J Carel
authors: JC
authors: Goslings
authors: Department of Surgery/Trauma Surgery, Leiden University Medical Centre, P.O. Box 9600, 2300 RC, Leiden, the Netherlands. i.b.schipper@lumc.nl.
authors: Inger B
authors: IB
authors: Schipper
authors: Department of Health Sciences and the EMGO-Institute, VU University, de Boelelaan 1085, 1081 HV, Amsterdam, the Netherlands. maurits.van.tulder@vu.nl.
authors: Maurits W
authors: MW
authors: van Tulder
mesh_terms: D064386:Ankle Fractures / Q000000981:diagnostic imaging* / Q000191:economics / Q000503:physiopathology / Q000628:therapy; D001175:Arthrography / Q000191:economics / Q000379:methods*; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004185:Disability Evaluation; D017102:Fracture Healing; D017048:Health Care Costs; D006801:Humans; D009426:Netherlands; D010147:Pain Measurement; D011237:Predictive Value of Tests; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014954:Wrist Injuries / Q000000981:diagnostic imaging* / Q000191:economics / Q000503:physiopathology / Q000628:therapy