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

Judd 2009.

Methods Study design: single‐centre, 2‐group, parallel‐design RCT
Duration of the study: February 2001‐June 2003
Protocol was published before recruitment of participants: not reported, but no protocol was published
Details of trial registration: not registered
Funding sources: study authors reported no potential conflict of interest and no funding sources
Participants Place of study: not reported, probably Hawaii
Number of participants assigned: 57 participants (29 surgical; 28 conservative)
Number of participants assessed: 57 participants (29 surgical; 28 conservative)
Inclusion criteria
  • Aged 17‐40 years

  • Isolated acute, displaced or angulated closed middle third clavicle fracture


Exclusion criteria
  • Open fractures

  • Neurological compromise

  • Medial or lateral third clavicle fracture


Age
  • Surgical group (mean/range): 28/19‐40 years

  • Conservative group (mean/range): 25/17‐41 years


Gender of participants assigned (male/female)
  • Surgical group: 27/2

  • Conservative group: 25/3


Classification of injury: not specified, just fracture pattern (comminuted and displacement/shortening fractures)
Interventions Timing of intervention: participants were treated within 2 weeks
Type of surgical intervention: open reduction and intramedullary fixation using a modified Hagie pin (Boehme 1991)
Type of conservative intervention: sling for comfort, restrictions of shoulder motion as tolerated and restrictions of activities until healing of fracture occurred
Rehabilitation: in both groups, gentle shoulder motion exercises and daily living activities were allowed as tolerated. After fracture healed, physical therapy with strength training and unrestricted activities were allowed.
Any co‐interventions: not reported
Outcomes Length of follow‐up:
  • The follow‐up was 1 year

  • Participants were evaluated at 3 and 6 weeks and at 3, 6 and 12 months


Loss to follow‐up: none lost to follow‐up
Primary outcomes
  • Function or disability measured by SANE and L' Insalata shoulder score

  • Failure of treatment


Secondary outcomes:
Other treatment failure measured by:
  • cosmetic results: prominent pins


Adverse events measured by:
  • superficial and deep infection

  • discomfort related to the implant

  • partial, transient radial nerve injury

  • refracture

Notes After fracture healing, all pins were removed under local anaesthesia.
Composite adverse events: surgery: local infection (n = 6); hardware prominence (n = 3); refracture (n = 2). Conservative: refracture (n = 1). In Analysis 1.14 we used event rates 6 for surgery and 1 for conservative.
Cosmetic result events: surgery: prominent pins (n = 9). Conservative: deformity (n = 0). In Analysis 1.11 we used event rates 9 for surgery and 0 for conservative.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported
Allocation concealment (selection bias) Low risk Sealed envelopes placed in a random order were used, and neither the treating surgeon nor the participant knew the intervention until the participant consented to participate in the study.
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 High risk Missing outcome data were not balanced in numbers across intervention groups; more participants in the conservative intervention group were not assessed at all time points.
Selective reporting (reporting bias) High risk Function or disability was measured by non‐standard validated participant‐reported measures.
Other bias Low risk The study appears to be free of other potential sources of bias.