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. 2015 Aug 13;2015(8):CD010606. doi: 10.1002/14651858.CD010606.pub2

NCT01553630.

Trial name or title Reamed Locked Plating ‐ Metaphyseal Fractures of the Distal Femur and Tibia
Methods Interventional, randomised study
Participants Both men and women
Inclusion criteria:
  • high‐energy metaphyseal fracture (distal femur or tibia) indicated for plate fixation (open or closed)

  • adult, acute fractures only


Exclusion criteria:
  • unable to ream fractured bone

  • participant unable, unwilling or unlikely to follow up

  • aged < 18 years

  • prisoners

Interventions ORIF with reamed irrigator aspirator bone graft
ORIF without reamed irrigator aspirator bone graft
Outcomes Primary outcomes:
  • time to union (time frame: 3 months, 6 months and 1 year). This will be evaluated with the reading of x‐rays


Secondary outcomes:
  • re‐operation rate (time frame: 3 months, 6 months, 1 year)

Starting date May 2010
Contact information Barbara Steverson
bsteverson@floridaortho.com
Notes