Status:
COMPLETED
A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures
Lead Sponsor:
Boston Medical Center
Conditions:
Femoral Fractures
Eligibility:
All Genders
Phase:
NA
Brief Summary
This study looks at two (2) types of surgical treatments and hopes to answer the question, "which is the best way to surgically treat a distal femur fracture?" Both procedures being studied are standa...
Detailed Description
The study is a randomized controlled multicenter trial in which individuals sustaining a fracture of the supracondylar (metaphyseal) region of the distal femur will be operatively managed by one of tw...
Eligibility Criteria
Inclusion
- Skeletally mature
- 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
- Fracture of the metaphyseal distal femur with intra-articular communition,
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00429663
Start Date
February 1 2007
End Date
December 1 2016
Last Update
May 11 2017
Active Locations (22)
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1
University of California - Davis
Sacramento, California, United States, 95817
2
Tampa General Hospital
Tampa, Florida, United States, 33606
3
Indiana University
Indianapolis, Indiana, United States, 46202
4
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201