title: Conservative management versus open reduction and internal fixation for mid-shaft clavicle fractures in adults--the Clavicle Trial: study protocol for a multicentre randomized controlled trial.
abstract: BACKGROUND
  Clavicle fractures account for around 4% of all fractures and up to 44% of fractures of the shoulder girdle. Fractures of the middle third (or mid-shaft) account for approximately 80% of all clavicle fractures. Management of this group of fractures is often challenging and the outcome can be unsatisfactory. In particular it is not clear whether surgery produces better outcomes than non-surgical management. Currently there is much variation in the use of surgery and a lack of good quality evidence to inform our decision.
  
  
  METHODS
  We aim to undertake a multicentre randomised controlled trial evaluating the effectiveness and safety of conservative management versus open reduction and internal fixation for displaced mid-shaft clavicle fractures in adults. Surgical treatment will be performed using the Acumed clavicle fixation system. Conservative management will consist of immobilisation in a sling at the side in internal rotation for 6 weeks or until clinical or radiological union. We aim to recruit 300 patients. These patients will be followed-up for at least 9 months. The primary endpoint will be the rate of non-union at 3 months following treatment. Secondary endpoints will be limb function measured using the Constant-Murley Score and the Disabilities of the Arm, Shoulder and Hand (DASH) Score at 3 and 9 months post-operatively.
  
  
  CONCLUSIONS
  This article presents the protocol for a multicentre randomised controlled trial. It gives extensive details of, and the basis for, the chosen methods, and describes the key measures taken to avoid bias and to ensure validity.
  
  
  BACKGROUND
  United Kingdom Clinical Research Network ID: 8665. The date of registration of the trial is 07/09/2006. The date the first patient was recruited is 18/12/2007.
authors.affiliation: Department of Orthopaedic and Trauma Surgery, Campus Bio-Medico University, Via Alvaro del Portillo, 200, 00128 Rome, Italy.
authors.forename: Umile Giuseppe
authors.initials: UG
authors.lastname: Longo
authors.forename: Sughran
authors.initials: S
authors.lastname: Banerjee
authors.forename: Julie
authors.initials: J
authors.lastname: Barber
authors.forename: Andrew
authors.initials: A
authors.lastname: Chambler
authors.forename: Carlos
authors.initials: C
authors.lastname: Cobiella
authors.forename: Steven
authors.initials: S
authors.lastname: Corbett
authors.forename: Mark
authors.initials: M
authors.lastname: Crowther
authors.forename: Steven
authors.initials: S
authors.lastname: Drew
authors.forename: Andrea
authors.initials: A
authors.lastname: Francis
authors.forename: Marcus
authors.initials: M
authors.lastname: Lee
authors.forename: Nicholas
authors.initials: N
authors.lastname: Garlick
authors.forename: Iain
authors.initials: I
authors.lastname: Packham
authors.forename: Yemi
authors.initials: Y
authors.lastname: Pearse
authors.forename: Andrew
authors.initials: A
authors.lastname: Richards
authors.forename: Chris
authors.initials: C
authors.lastname: Roberts
authors.forename: Duncan
authors.initials: D
authors.lastname: Tennent
authors.forename: Emily
authors.initials: E
authors.lastname: Tims
authors.forename: Philip Michael
authors.initials: PM
authors.lastname: Ahrens
mesh_terms: D000328:Adult; D002968:Clavicle / Q000000981:diagnostic imaging / Q000293:injuries / Q000601:surgery*; D004185:Disability Evaluation; D004739:England; D005592:Fracture Fixation / Q000009:adverse effects / Q000379:methods*; D005593:Fracture Fixation, Internal / Q000009:adverse effects; D017102:Fracture Healing; D050723:Fractures, Bone / Q000175:diagnosis / Q000000981:diagnostic imaging / Q000601:surgery*; D006801:Humans; D007103:Immobilization; D026741:Physical Therapy Modalities; D011859:Radiography; D020127:Recovery of Function; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome