A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures

Completed · Not applicable

Conditions studied: Femoral Fractures

In brief

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 standard of care (used routinely) and use FDA approved devices. All medical and surgical treatment will be the same for participants as non-participants.

Key facts

Study ID

NCT00429663

Run by

Boston Medical Center

People needed

160

Starts

2007-02-01

Expected to finish

2016-12-01

Last updated by the study team

2017-05-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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