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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 8, 2012
Last Updated Date	March 13, 2012
Start Date ^ICMJE	May 2010
Estimated Primary Completion Date	February 2015 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 13, 2012)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01553630 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 13, 2012)	Reoperation rate [ Time Frame: 3 months, 6 months, 1 year ] [ Designated as safety issue: No ] The rate of re operation will be evaluated
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Reamed Locked Plating - Metaphyseal Fractures of the Distal Femur and Tibia
Official Title ^ICMJE	Reamed Locked Plating - Metaphyseal Fractures of the Distal Femur and Tibia
Brief Summary	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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label
Condition ^ICMJE	Metaphyseal Fractures of the Distal Femur and Tibia
Intervention ^ICMJE	Procedure: reamed irrigator Aspirator (RIA) bonegraft Acute autogenous bone grafting at the time if fsurgical fixation.
Study Arm (s)	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.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	50
Estimated Completion Date	February 2015
Estimated Primary Completion Date	February 2015 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 90 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01553630
Other Study ID Numbers ^ICMJE	Reamed Locked Plating
Has Data Monitoring Committee	No
Responsible Party	Florida Orthopaedic Institute
Study Sponsor ^ICMJE	Florida Orthopaedic Institute
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Florida Orthopaedic Institute
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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