title: HUMeral shaft fractures: measuring recovery after operative versus non-operative treatment (HUMMER): a multicenter comparative observational study.
abstract: BACKGROUND
  Fractures of the humeral shaft are associated with a profound temporary (and in the elderly sometimes even permanent) impairment of independence and quality of life. These fractures can be treated operatively or non-operatively, but the optimal tailored treatment is an unresolved problem. As no high-quality comparative randomized or observational studies are available, a recent Cochrane review concluded there is no evidence of sufficient scientific quality available to inform the decision to operate or not. Since randomized controlled trials for this injury have shown feasibility issues, this study is designed to provide the best achievable evidence to answer this unresolved problem. The primary aim of this study is to evaluate functional recovery after operative versus non-operative treatment in adult patients who sustained a humeral shaft fracture. Secondary aims include the effect of treatment on pain, complications, generic health-related quality of life, time to resumption of activities of daily living and work, and cost-effectiveness. The main hypothesis is that operative treatment will result in faster recovery.
  
  
  METHODS
  The design of the study will be a multicenter prospective observational study of 400 patients who have sustained a humeral shaft fracture, AO type 12A or 12B. Treatment decision (i.e., operative or non-operative) will be left to the discretion of the treating surgeon. Critical elements of treatment will be registered and outcome will be monitored at regular intervals over the subsequent 12 months. The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand score. Secondary outcome measures are the Constant score, pain level at both sides, range of motion of the elbow and shoulder joint at both sides, radiographic healing, rate of complications and (secondary) interventions, health-related quality of life (Short-Form 36 and EuroQol-5D), time to resumption of ADL/work, and cost-effectiveness. Data will be analyzed using univariate and multivariable analyses (including mixed effects regression analysis). The cost-effectiveness analysis will be performed from a societal perspective.
  
  
  CONCLUSIONS
  Successful completion of this trial will provide evidence on the effectiveness of operative versus non-operative treatment of patients with a humeral shaft fracture.
  
  
  BACKGROUND
  The trial is registered at the Netherlands Trial Register (NTR3617).
authors: Kiran C
authors: KC
authors: Mahabier
authors: Trauma Research Unit Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P,O, Box 2040, 3000 CA Rotterdam, The Netherlands. e.vanlieshout@erasmusmc.nl.
authors: Esther M M
authors: EM
authors: Van Lieshout
authors: Hugo W
authors: HW
authors: Bolhuis
authors: P Koen
authors: PK
authors: Bos
authors: Maarten Wga
authors: MW
authors: Bronkhorst
authors: Milko M M
authors: MM
authors: Bruijninckx
authors: Jeroen
authors: J
authors: De Haan
authors: Axel R
authors: AR
authors: Deenik
authors: Boudewijn J
authors: BJ
authors: Dwars
authors: Martin G
authors: MG
authors: Eversdijk
authors: J Carel
authors: JC
authors: Goslings
authors: Robert
authors: R
authors: Haverlag
authors: Martin J
authors: MJ
authors: Heetveld
authors: Albert J H
authors: AJ
authors: Kerver
authors: Karel A
authors: KA
authors: Kolkman
authors: Peter A
authors: PA
authors: Leenhouts
authors: Sven A G
authors: SA
authors: Meylaerts
authors: Ron
authors: R
authors: Onstenk
authors: Martijn
authors: M
authors: Poeze
authors: Rudolf W
authors: RW
authors: Poolman
authors: Bas J
authors: BJ
authors: Punt
authors: W Herbert
authors: WH
authors: Roerdink
authors: Gert R
authors: GR
authors: Roukema
authors: Jan Bernard
authors: JB
authors: Sintenie
authors: Nicolaj M R
authors: NM
authors: Soesman
authors: Andras K F
authors: AK
authors: Tanka
authors: Edgar J T
authors: EJ
authors: Ten Holder
authors: Maarten
authors: M
authors: Van der Elst
authors: Frank H W M
authors: FH
authors: Van der Heijden
authors: Frits M
authors: FM
authors: Van der Linden
authors: Peer
authors: P
authors: Van der Zwaal
authors: Jan P
authors: JP
authors: Van Dijk
authors: Hans-Peter W
authors: HP
authors: Van Jonbergen
authors: Egbert J M M
authors: EJ
authors: Verleisdonk
authors: Jos P A M
authors: JP
authors: Vroemen
authors: Marco
authors: M
authors: Waleboer
authors: Philippe
authors: P
authors: Wittich
authors: Wietse P
authors: WP
authors: Zuidema
authors: Suzanne
authors: S
authors: Polinder
authors: Michael H J
authors: MH
authors: Verhofstad
authors: Dennis
authors: D
authors: Den Hartog
mesh_terms: D000203:Activities of Daily Living; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004185:Disability Evaluation; D005592:Fracture Fixation / Q000191:economics / Q000379:methods*; D017102:Fracture Healing; D017048:Health Care Costs; D006801:Humans; D006810:Humeral Fractures / Q000175:diagnosis / Q000191:economics / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D009426:Netherlands; D010147:Pain Measurement; D011446:Prospective Studies; D020127:Recovery of Function; D012107:Research Design; D062707:Return to Work; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome