Skip to main content
. 2015 May 7;2015(5):CD007428. doi: 10.1002/14651858.CD007428.pub3

Ferran 2010.

Methods Study design: randomised controlled trial
Duration of the study: 2006‐2008
Protocol was published before recruitment of participants: not reported
Details of trial registration: not reported
Funding sources: no conflict of interest
Participants Place of study: Wales, UK
Number of participants assigned: 32 (17 intramedullary group; 15 plate group)
Number of participants assessed: 32 (17 intramedullary group; 15 plate group)
Inclusion criteria:
  • People with isolated middle third clavicle fracture with displacement and shortening (complete overlap of bone ends or a displaced butterfly fragment)

  • Participants had to be able to consent to the trial


Exclusion criteria:
  • Polytrauma

  • Inability to give consent

  • Concurrent upper limb injuries

  • Medical contraindications to surgery

  • People with fractures with comminution extending laterally


Age (mean/range):
  • Intramedullary group: 23.8/13‐42 years

  • Plate group: 32.4/16‐53 years


Gender (male/female):
  • Intramedullary group: 14/3

  • Plate group: 13/2


Side of injury (dominant/non‐dominant): not reported
Classification of injury: not reported
Interventions Timing of intervention (mean/SD):
  • Intramedullary group: 13.3/5.6 days

  • Plate group: 13.3/9.1 days


Intervention 1 (Intramedullary group):
  • Open reduction and internal fixation with Rockwood Pin


Intervention 2 (Plate group):
  • Open reduction and internal fixation with superior LC‐DCP plate


Rehabilitation:
For both groups, participants received arm sling protection for 2 weeks postoperatively and were encouraged to perform regular pendular exercises
At 2 weeks, participants initiated gleno‐humeral range of motion exercises. For the first 6 weeks, abduction and forward flexion were limited to 90°. Beyond 6 weeks, full range of gleno‐humeral motion was encouraged
Any co‐interventions: not reported
Outcomes Length of follow‐up:
  • Total follow‐up was 12 months

  • Participants were evaluated at 2 and 6 weeks, 3, 6, and 12 months


Loss of follow‐up: 0 lost to follow‐up.
Primary outcomes:
  • Function or disability measured by Constant score and OSS

  • Pain evaluated by Constant score for pain

  • Failure of treatment measured by: mechanical failure (metalwork loosened)


Secondary outcomes:
  • Clinical fracture radiographic union

  • Adverse events, measured by:

    • wound infection

    • symptomatic hardware

    • hardware irritation requiring removal

    • scars numbness

Notes After fracture healing, all pins were removed under local anaesthesia
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The method of generating the random sequence was not reported
Allocation concealment (selection bias) Low risk Opaque and sealed envelopes were used
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 Low risk There were no missing data
Selective reporting (reporting bias) High risk The authors did not report outcomes at each time point, it was unclear when the outcomes were collected
Other bias High risk Major baseline imbalance related to age of participants