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



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:9/7/2018
Start Date:February 2007
End Date:December 2020
Contact:Paul Tornetta
Email:heather.desjardin@bmc.org
Phone:617-414-6295

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Intramedullary Nail Versus Plate Fixation Re-Evaluation Study in Proximal Tibial Fractures: A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation (IMPRESS)

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.

The study is a multicenter randomized controlled trial in which individuals sustaining a
fracture of the proximal metaphysis of the tibia will be operatively managed by one of two
strategies. The first strategy involves fixation of the fracture with a reamed, interlocking
intramedullary nail (Nail Group). The second treatment strategy involves open reduction and
internal fixation of the fracture with a locking periarticular plate (Plate Group). The null
hypothesis of the study is that there will be no difference in the two groups with respect to
the primary and secondary outcome measures. To the degree possible, patients in the two
groups will receive post-operative care according to the same standards and protocols.

Inclusion Criteria:

- 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 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

Exclusion Criteria:

- 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.
We found this trial at
29
sites
Memphis, Tennessee 38104
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-494-6376
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Ann Arbor, Michigan 48109
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Birmingham, Alabama 35294
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Boston, Massachusetts 02118
Phone: 617-414-5793
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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Columbus, OH
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Davis, California 95616
Phone: 916-734-6291
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Davis, CA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Fort Worth, TX
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Grand Rapids, Michigan 49525
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Indianapolis, Indiana 46202
Principal Investigator: Todd McKinley, MD
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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London, Ontario
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Minneapolis, Minnesota 55414
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New York, New York 10003
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Oklahoma City, Oklahoma 73190
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Rochester, Minnesota 55902
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4483 Duncan Avenue
Saint Louis, Missouri 63110
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3635 Vista Avenue
Saint Louis, Missouri 63110
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San Francisco, California 94143
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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Worcester, Massachusetts 01605
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