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. 2016 Dec 15;2016(12):CD007121. doi: 10.1002/14651858.CD007121.pub4

Ersen 2015.

Methods Study design: RCT
Duration of the study: August 2012 and September 2013
Protocol was published before recruitment of patients: not reported
Details of trial registration: not reported
Intention‐to‐treat analysis: Likely, but outcome data for participants who had withdrawn from the trial or were lost to follow‐up were not presented
Funding sources: the authors reported that no benefits in any form were received or will be received from a commercial party related directly or indirectly to the subject of this article
Participants Location: Istanbul, Turkey
Number of participants assigned: 60 (30 figure‐of‐eight bandage group; 30 arm sling group)
Number of participants assessed: 51 (23 figure‐of‐eight bandage group; 28 arm sling group)
Inclusion criteria:
  • Participants with an isolated, mid‐shaft clavicular fracture

  • Acute fracture (presented on the day of injury)

  • Aged ≥ 15 years


Exclusion criteria:
  • Participants with fractures of other parts of the clavicle

  • Pathological fracture

  • Open fracture

  • Polytrauma

  • Presentation delayed beyond 24 hours post injury


Age (mean; range):
  • Figure‐of‐eight bandage group: 28.7; 15 to 72 years

  • Arm sling group: 33.5; 16 to 75 years


Gender (male/female):
  • Figure‐of‐eight bandage group: 19/4

  • Arm sling group: 22/6


Side of injury (dominant/non‐dominant):
  • Figure‐of‐eight bandage group: 13/10

  • Arm sling group: 15/13


Classification of injury (displaced/not displaced):
  • Figure‐of‐eight bandage group: 15/8

  • Arm sling group: 18/10

Interventions Timing of intervention: All participants were assessed on the day of injury
Intervention 1 (figure‐of‐eight bandage):
  • Patients and relatives of those in the figure of eight bandage were educated on how to tighten the bandage when it loosened. The patients were free to use their arms.


Intervention 2 (arm sling):
  • The upper limb was immobilised in internal rotation with the sling for three weeks.


Rehabilitation: not reported
Any co‐interventions: not reported
Outcomes Length of follow‐up:
  • Total follow‐up was (mean; range): 8.2 / 6 to 12 months

  • Participants were evaluated at the next day (day one), and on days 3, 7, 14 and 21 for pain. Anteroposterior (AP) radiographs were assessed at weeks 4, 8 and 12 and the time to union


Loss of follow‐up: nine participants lost to follow‐up:
Figure‐of‐eight bandage group ‐ seven participants lost to follow‐up:
  • Unable to come to the hospital (3 participants)

  • Discontinued intervention (3 participants)

  • Not followed the study protocol (1 participant)


Arm sling group ‐ two participants lost to follow‐up:
  • Unable to come to the hospital (1 participant)

  • Discontinued intervention (1 participant)


Primary outcomes:
  • Function or disability measured by Constant and American Shoulder and Elbow Surgeons scores

  • Pain evaluated by VAS from 0 to 10 (no pain to worst pain)

  • Failure of treatment measured


Secondary outcomes:
  • Clinical fracture radiographic union

  • Adverse events, measured by:

    • Radiological shortening

    • Discomfort with the use of immobilisation

  • Return to previous activities (work and school), including time to return

  • Patient satisfaction with method of treatment

Notes We found some data discrepancies between text and tables of paper – all data were checked by authors’ via email. This confirmed the denominators at follow‐up were 23 figure‐of‐eight bandages and 28 arm slings
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk The authors employed non‐stratified randomisation in blocks of two using the sealed envelope method, so when one patient had chosen an envelope, the next patient would be allocated to a group according to the remaining envelope of the pair
Allocation concealment (selection bias) High risk Allocation was not concealed
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 Outcomes assessors were not blinded
Incomplete outcome data (attrition bias) 
 All outcomes High risk Only 82% of participants completed the follow‐up. Missing outcome data were not balanced in numbers across intervention groups; more participants in the figure‐of‐eight group were lost to follow‐up at 12 months; (2/30 (6.7%) in sling group vs. 7/30 (23.3%) in figure‐of‐eight group). This may have overestimated the benefits of sling
Selective reporting (reporting bias) High risk The study protocol was not available. Function or disability was measured by validated scores, however, only at the end of follow‐up that raged by 6 to 12 months ‐ the authors did not report functional outcomes at each time point
Other bias High risk The results were published in imprecise format. We found some data discrepancies between text and tables of paper