Reamed Locked Plating - Metaphyseal Fractures of the Distal Femur and Tibia

This study is currently recruiting participants.
Verified March 2012 by Florida Orthopaedic Institute
Sponsor:
Information provided by (Responsible Party):
Florida Orthopaedic Institute
ClinicalTrials.gov Identifier:
NCT01553630
First received: March 8, 2012
Last updated: March 13, 2012
Last verified: March 2012

March 8, 2012
March 13, 2012
May 2010
February 2015   (final data collection date for primary outcome measure)
Time to union [ Time Frame: 3 months, 6 months and 1 year ] [ Designated as safety issue: No ]
This will be evaluated with the reading of xrays
Same as current
Complete list of historical versions of study NCT01553630 on ClinicalTrials.gov Archive Site
Reoperation rate [ Time Frame: 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]
The rate of re operation will be evaluated
Same as current
Not Provided
Not Provided
 
Reamed Locked Plating - Metaphyseal Fractures of the Distal Femur and Tibia
Reamed Locked Plating - Metaphyseal Fractures of the Distal Femur and Tibia

Comminuted metaphyseal fractures (OTA classification A2/3 and C2/3) of the distal femur and distal tibia are difficult to treat and typically have more complications than other metaphyseal fractures. Delayed union, nonunion and need for secondary bone graft procedures are frequent outcomes. These A2/3 and C2/3 fractures of the distal femur and distal tibia treated with locked plates often have a critical sized fracture gap (poorly organized cortical pieces many of which are stripped of soft tissue). Optimal management strategies that minimize both fracture healing time and complication rates remain controversial. Primary bone grafts or early secondary bone grafts have been recommended for these comminuted open fractures, but have not been studied as the primary end point in a randomized trial. There is a need to study primary bone grafting during open reduction and internal fixation (plating) of these difficult fractures, to determine if shorter healing time, and thus less need for reoperation, can be achieved.

Hypothesis Acute autogenous bone grafting at the time of fixation will hasten clinical and radiographic union with a lower need for secondary procedures

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Metaphyseal Fractures of the Distal Femur and Tibia
Procedure: reamed irrigator Aspirator (RIA) bonegraft
Acute autogenous bone grafting at the time if fsurgical fixation.
  • Active Comparator: Reamed Irrigator Aspirator (RIA) bone graft
    open reduction and internal fixation (ORIF) of high energy metaphyseal fractures with Reamed Irrigator Aspirator (RIA) bone graft at the time of fixation.
    Intervention: Procedure: reamed irrigator Aspirator (RIA) bonegraft
  • No Intervention: without Reamed Irrigator Aspirator (RIA) bone graft
    open reduction and internal fixation (ORIF) of high energy metaphyseal fractures without Reamed Irrigator Aspirator (RIA) bone graft at the time of fixation.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
February 2015
February 2015   (final data collection date for primary outcome measure)

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
  • Subject is unable, unwilling or unlikely to follow up
  • Subject is under age 18 years
  • Prisoners
Both
18 Years to 90 Years
No
Not Provided
United States
 
NCT01553630
Reamed Locked Plating
No
Florida Orthopaedic Institute
Florida Orthopaedic Institute
Not Provided
Not Provided
Florida Orthopaedic Institute
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP