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. 2019 Jan 22;2019(1):CD009363. doi: 10.1002/14651858.CD009363.pub3

Figueiredo 2008.

Methods Study design: single‐centre, 2‐group, parallel‐design RCT
Duration of the study: August 2005‐January 2007
Protocol was published before recruitment of participants: not reported, but no protocol was published
Details of trial registration: not registered
Funding sources: none known
Participants Place of study: 1 centre from Taubaté, Brazil
Number of participants assigned: 50 participants
Number of participants assessed: 40 participants (24 surgical; 16 conservative)
Inclusion criteria
  • Aged > 18 years

  • Healthy patients (not specified)

  • Middle third acute clavicle fracture

  • Displacement > 20 mm


Exclusion criteria
  • Not reported


Age
  • Surgical group (mean/SD): 28.2/8.1 years

  • Conservative group (mean/SD): 33.2/15.1 years


Gender of participants assessed (male/female)
  • Surgical group: 19/5

  • Conservative group: 12/4


Classification of injury: not specified
Interventions Timing of intervention: not reported
Type of surgical intervention: open reduction with 3.5‐mm DCP plate fixation (antero‐inferior position)
Type of conservative intervention: Velpeau sling for 6 weeks
Rehabilitation:
  • Surgical group: standard sling was used for comfort for 10 days, physiotherapy was not specified

  • Conservative group: physiotherapy after 6 weeks (not specified)


Any co‐interventions: not reported
Outcomes Length of follow‐up (mean/range): 16/12‐24 months. The length of follow‐up was not pre‐specified
Loss to follow‐up: 10 participants were lost to follow‐up:
  • 6 did not attend for examination

  • 3 did not accept the treatment after randomisation

  • 1 died


Primary outcomes
  • Function or disability measured by UCLA score (0‐35 point scale, higher score indicates better function)

  • Failure of treatment


Secondary outcomes
Other treatment failure measured by:
  • cosmetic result: deformity, hypertrophic scar


Adverse events measured by:
  • Long‐term follow‐up: stiffness/restricted of range of shoulder movement (adhesive capsulitis)


Return to previous activities:
  • time to return to work and activities of daily living

Notes Composite adverse events: surgery: (n = 0). Conservative: stiffness/restricted range of shoulder movement (n = 2). In Analysis 1.14 we used event rates 0 for surgery and 2 for conservative.
Cosmetic result events: surgery: unsightly scar (n = 3). Conservative: deformity (n = 7). In Analysis 1.11 we used event rates 3 for surgery and 7 for conservative.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants and personnel were not blinded
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Outcome assessors were not blinded
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk The study authors did not specify which groups the 10 participants that were lost to follow‐up belonged to
Selective reporting (reporting bias) High risk Pain (as primary outcome) was reported incompletely so that it cannot be entered into a meta‐analysis
Other bias High risk The time points of outcomes were not pre‐specified