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. 2015 May 7;2015(5):CD007428. doi: 10.1002/14651858.CD007428.pub3

Tabatabaei 2011.

Methods Study design: quasi‐randomised controlled trial
Duration of the study: April 2008 to December 2010
Protocol was published before recruitment of participants: not reported
Details of trial registration: prospectively registered in 2007 at WHO International Clinical Trial Registry (IRCT201105165920N3)
Funding sources: study was supported by the grant number 2228 from Jundishapur University of Medical Sciences
Participants Place of study: Iran
Number of participants assigned: 68 (34 intramedullary group; 34 plate group)
Number of participants assessed: 50 (25 intramedullary group; 25 plate group)
Inclusion criteria:
  • people with middle third clavicular fracture with > 2 cm of displacement or shortening


Exclusion criteria:
  • People without any other musculoskeletal or neurological injury


Age (mean/SD/range):
  • Intramedullary group: 28.2/9.9/18‐48 years

  • Plate group: 29.2/7.9/18‐48 years


Gender (male/female):
  • Intramedullary group: 21/4

  • Plate group: 21/4


Side of injury (dominant/non‐dominant): not reported
Classification of injury: AO classification but the authors did not report
Interventions Timing of intervention: not reported.
Intervention 1 (Intramedullary group):
  • Open reduction and internal fixation with smooth 3.5 mm pin


Intervention 2 (Plate group):
  • Open reduction and internal fixation with superior 3.5 mm LC‐DCP plate


Rehabilitation: the postoperative protocol was Velpeau bandage for a few days and then sling and early pendulum exercise. In the 6th week, if there was radiological union, the participant was allowed to perform restricted exercise. The participants were instructed not to perform contact sports until 12th week post operation
Any co‐interventions: not reported
Outcomes Length of follow‐up: mean follow‐up was 6 months for all participants with clinical assessment at 2, 4, and 6 weeks and 6 months after operation
Loss of follow‐up: 18 participants lost to follow‐up at 6 months:
Primary outcomes:
  • Function or disability measured by DASH and OSS

  • Failure of treatment


Secondary outcomes:
  • Clinical fracture healing: time to clinical and radiographic union

  • Adverse events, measured by:

    • wound infection or dehiscence

    • cosmetic result: poor outcome such as deformity, asymmetrical result, and skin problems

    • symptomatic non‐union that is not being considered for surgery, radiographic malunion

    • symptomatic hardware and hardware irritation requiring removal

    • other reported complication


Other outcomes assessed:
  • Duration of surgery

  • Mean blood loss

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Sequence generated by some rule based on date (alternation): "We operated the first patient with pin and the other with plate and continued the operations in the same manner"
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 > 80% of participants completed the follow‐up (50/68 participants, 73.5%)
Selective reporting (reporting bias) High risk Outcomes of interest in the review are not reported (function, pain, and quality of life)
Other bias Unclear risk Insufficient information to permit judgement

3D: three‐dimensional; AO: Arbeitsgemeinschaft fur Osteosynthesefragen; DASH: Disabilities of the Arm, Shoulder and Hand questionnaire; DCP: dynamic compression plate; LC‐DCP: low‐contact dynamic compression plate; SD: standard deviation; TEN: titanium elastic nail; VAS: visual analogue scale; WHO: World Health Organization.