A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures
NCT ID: NCT00429663
Last Updated: 2017-05-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2007-02-28
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IM Nails
Reamed, Interlocking Intramedullary Nail - Randomized treatment
reamed, interlocking intramedullary nail
Standard of care device for femur fracture repair
Plate Fixation
Locking Periarticular Plate - Randomized Treatment
locking periarticular plate
Standard of care device for femur fractures
Interventions
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reamed, interlocking intramedullary nail
Standard of care device for femur fracture repair
locking periarticular plate
Standard of care device for femur fractures
Eligibility Criteria
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Inclusion Criteria
* Fracture of the metaphyseal distal femur with or without intra-articular extension and with or without a TKA
* Fracture requiring operative treatment amenable to either IM nail or plate
* Informed consent obtained
* Patient is English speaking
Exclusion Criteria
* Fracture with vascular injury (Gustillo Type IIIC injury) requiring repair,
* Pathological fracture,
* Known metabolic bone disease,
* Contralateral distal femur fractures (bilateral injury) or ipsilateral lower extremity injury that would compromise function of the knee
* Retained hardware or existing deformity in the affected limb that would complicate IM nailing or plating
* Symptomatic knee arthritis
* Soft tissue injuries compromising either treatment method with nail or plate
* Surgical delay greater than 3 weeks for closed fractures or 24 hours for open fractures
* Immunocompromised
* Unable to comply with postoperative rehabilitation protocols or instructions (i.e. head injured or mentally impaired)
* Current or impending incarceration
* Unlikely to follow-up in surgeon's estimation
ALL
No
Sponsors
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Boston Medical Center
OTHER
Responsible Party
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Paul Tornetta, III, M.D.
Paul Tornetta,III,M.D
Principal Investigators
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Paul Tornetta, M.D.
Role: PRINCIPAL_INVESTIGATOR
Boston University
Locations
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University of California - Davis
Sacramento, California, United States
Tampa General Hospital
Tampa, Florida, United States
Indiana University
Indianapolis, Indiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worchester, Massachusetts, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
St. Mary's Hospital - Mayo Clinic
Rochester, Minnesota, United States
Barnes Hospital
St Louis, Missouri, United States
St. Louis University Hospital
St Louis, Missouri, United States
Cooper University Hospital
Camden, New Jersey, United States
New York Hospital for Joint Diseases
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Ohio State University Medical Center
Columbus, Ohio, United States
University of Oklahoma/ Health Science
Oklahoma City, Oklahoma, United States
Oregon Health and Sciences University
Portland, Oregon, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Campbell Foundation
Memphis, Tennessee, United States
Orthopaedic Specialty Associates Fort Worth
Fort Worth, Texas, United States
Harborview Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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H-25934
Identifier Type: -
Identifier Source: org_study_id
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