A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Proximal Tibial Fractures

Completed · Not applicable

Conditions studied: Tibial Fractures

In brief

This study looks at two types of surgical treatments and hopes to answer the question: which is the best way to surgically treat a proximal tibia 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

NCT00429585

Run by

Boston Medical Center

People needed

108

Starts

2007-02-01

Expected to finish

2020-12-16

Last updated by the study team

2021-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Skeletally mature,
• Extra-articular fracture of the proximal tibia extending into the metaphyseal with or without intra-articular extension not requiring open reduction with complete anteroposterior (AP) and lateral radiographs,
• Major fracture line not closer than 4cm from the proximal tibial articular surface
• Fracture requiring operative treatment amenable to either IM nail or plate
• Surgeon agreed to randomize patient
• Informed consent obtained
• Patient is English speaking

You may not qualify if…

• Tibial shaft fractures not amenable to intramedullary nailing (i.e.fracture is less than 4 cm from joint surface),
• Fracture of the proximal tibia with intraarticular extension requiring open reduction,
• Known metabolic bone disease
• Separate displaced tibial tubercle fragment,
• Soft tissue injuries compromising treatment method with nail,plate or both.
• Fractures with vascular injury (Gustillo Type IIIC injury) requiring repair,
• Compartment syndrome of the leg diagnosed preoperatively,
• Pathological fractures,
• Retained hardware or existing deformity in the affected limb that would complicate IM nailing,plating or both,
• Symptomatic knee arthritis.
• 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 Alabama - Burmingham — Birmingham, Alabama, United States
• University of California at Davis — Davis, California, United States
• University of California-San Francisco — San Francisco, California, United States
• Tampa General Hospital — Tampa, Florida, United States
• Indiana University — Indianapolis, Indiana, United States
• IU Health Methodist Hospital — Indianapolis, Indiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• UMass Memorial Medical Center — Worcester, 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
• Duke University Medical Center — Durham, North Carolina, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• University of Oklahoma/ Health Science — Oklahoma City, Oklahoma, United States
• Oregon health and science university — Portland, Oregon, United States
• University Of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Campbell Foundation — Memphis, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.