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

Andersen 1987a.

Methods Study design: RCT
Duration of the study: June 1981 to September 1982
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Intention‐to‐treat analysis: Likely, but outcome data for participants who had withdrawn from the trial or were lost to follow‐up were not presented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: not reported
Participants Location: Denmark
Number of participants assigned: 79 (49 figure‐of‐eight bandage group; 34 arm sling group)
Number of participants assessed: 61 (34 figure‐of‐eight bandage group; 27 arm sling group)
Inclusion criteria:
  • People with middle third clavicle fractures

  • Aged > 13 years

  • Patient informed consent


Exclusion criteria:
  • Perforation of the skin or primary neurovascular symptoms


Age (median; range):
  • Figure‐of‐eight bandage group: 19; 14 to 81 years

  • Arm sling group: 19; 14 to 66 years


Gender: not reported
Side of injury: not reported
Classification of injury: not reported, just fracture types (2 fragments, 1 intermediary fragment and 2 or more intermediary fragments) and fracture dislocations (undisplaced, minor displacement, major displacement)
Interventions Timing of intervention: after diagnosis
Intervention 1 (figure‐of‐eight bandage):
  • After 2 days, and 1 and 2 weeks, this method was checked and adjusted by participant's own general practitioner. This immobilisation was used for 3 weeks. All participants were stimulated to move the shoulder as soon as possible


Intervention 2 (arm sling):
  • Simple sling was used only as long as the patient felt a need for it. All participants were stimulated to move the shoulder as soon as possible


Rehabilitation: not reported
Any co‐interventions: not reported
Outcomes Length of follow‐up:
The figure‐of‐eight group lasted a median interval of 12 weeks (10 to 16) and the sling group lasted a median interval of 13 weeks (10 to 17); the figure‐of‐eight group also was assessed at 2 days, 1 and 2 weeks
Loss of follow‐up: 18 participants lost to follow‐up:
Figure‐of‐eight bandage group ‐ 11 participants lost to follow‐up:
  • Refused bandage (1 participant)

  • Bandage removal (1 participant)

  • DVT (1 participant)

  • Fracture displacement (2 participants)

  • Defaulted the follow‐up examination (6 participants)


Arm sling group ‐ two seven participants lost to follow‐up:
  • Patient confined to bed for 5 weeks (1 participant)

  • Treatment with Velpeau for 1 week (1 participant)

  • Patient suffered hemiplegia (1 participant)

  • Defaulted on follow‐up examination (4 participants)


Primary outcomes:
  • Shoulder function; this was assessed using a non‐validated score

  • Pain: use of analgesics and duration of pain


Secondary outcomes:
  • Adverse events: deformity at fracture site, skin problems, neurovascular symptoms, impairment of shoulder motion, weakness of shoulder muscles, pain from movement and tenderness of fracture site; other complications (not specified)

  • Radiographic outcomes: healing of fracture, amount of callus and displacement

  • Patient satisfaction with type of treatment

  • Other outcomes: duration of bandaging, discomfort from treatment, severity of discomfort, duration of discomfort, number of visits to general practitioner, duration of functional impairment, duration of sick leave/disablement

Notes The outcomes were evaluated by a non‐validated scoring system
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random numbers table was used
Allocation concealment (selection bias) Unclear risk Details to ascertain that allocation was concealed were not provided
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 Less than 80% of participants completed the follow‐up (23% of withdrawals)
Selective reporting (reporting bias) High risk The authors used non‐validated scores to assess function and pain; treatment failure was not reported
Other bias Unclear risk Insufficient information to permit judgement