Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures



Status:Recruiting
Conditions:Orthopedic, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 75
Updated:3/17/2019
Start Date:February 14, 2017
End Date:December 2019
Contact:Erin Mundstock, BS
Email:erin.mundstock@bonesupport.com
Phone:781-772-1756

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A Prospective, Randomized Multicenter Controlled Trial of CERAMENT™|G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures

The purpose of this study is to demonstrate the safety and effectiveness of CERAMENT™|G used
in conjunction with standard-of-care treatment compared to standard-of-care treatment alone
in the care of subjects with open fractures of the tibial diaphysis.

CERAMENT™|G is a resorbable, gentamicin containing ceramic bone graft indicated to fill bony
voids or gaps which are not intrinsic to the stability of the bony structure and where there
is risk of bacterial contamination.

1. Male or female 18-21 years of age with radiographic evidence on plain x-rays of
proximal and distal tibial physeal closure, OR male or female 22-75 years of age

2. Gustilo-Anderson Grade II, IIIA, or IIIB open tibial shaft fracture (with or without
involvement of the tibial plateau or pilon/plafond) amenable to fixation with an
intramedullary nail

3. Bone loss at the fracture site must have a radiographic apparent bone gap (RABG)
between 3 and 27.5 millimeters.

4. Life expectancy of at least 1 year

5. Patient is willing to provide informed consent, is geographically stable and able to
comply with the required follow up visits, testing schedule and medication regimen

6. Adequate soft tissue coverage at the fracture site (through primary closure or
surgical reconstruction, including local and free soft tissue transfer)

7. Definitive wound closure within 10 days of the initial injury

8. Unilateral fracture, or, in the case of individually-qualifying bilateral open tibia
fractures, the more severe of the bilateral fractures.

Patients will be excluded if ANY of the following conditions apply:

1. Pregnant or breastfeeding women or planning on becoming pregnant during the
investigational period

2. Patient is currently participating in an investigational drug or other device study or
previously enrolled in this study

3. Renal failure or documented chronic kidney disease with serum creatinine ≥3.5 mg/L or
being treated with dialysis

4. Known hypersensitivity to aminoglycoside antibiotics, calcium sulfate or calcium
hydroxyapatite

5. Pre-existing calcium metabolism disorder

6. Uncontrolled diabetes mellitus (hemoglobin A1c levels > 10%)

7. A current endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's
disease, renal osteodystrophy, hyperthyroidism, parathyroid hormone disorder,
Ehler-Danlos syndrome, osteogenesis imperfecta)

8. Neuromuscular disorders such as myasthenia gravis or Parkinson's disease

9. Currently has untreated malignant neoplasm(s), or is currently undergoing radiation
therapy or chemotherapy

10. Inadequate neurovascular status in the involved limb that may jeopardize healing
(e.g., Gustilo-Anderson IIIc classification)

11. Previous history of osteomyelitis in the index limb

12. Ipsilateral tibial plateau or pilon/plafond fractures requiring a reconstruction that
interferes with or prohibits the use of an intramedullary nail to stabilize the tibial
shaft fracture or, in the opinion of the investigator, the treatment and/or
rehabilitation of such fracture(s) would substantially interfere with the treatment,
rehabilitation or other requirements of open tibial shaft fractures enrolled under
this protocol.

13. Other ipsilateral lower extremity fracture(s) if, in the opinion of the investigator,
the treatment and/or rehabilitation of such fracture(s) will substantially interfere
with the treatment, rehabilitation or other requirements outlined in this protocol.
We found this trial at
19
sites
Saint Louis, Missouri 63110
Principal Investigator: Anna Miller, MD
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Michael Johnson, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Jason Strelzow, MD
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: Geoffrey Marecek, MD
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: William Obremskey, MD
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Albuquerque, New Mexico 87131
(505) 277-0111
Principal Investigator: Rick Gehlert, MD
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Albuquerque, NM
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101 Preuschwitzer Straße
Bayreuth, 95445
Principal Investigator: Rupert Schupfner, Dr.
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Bayreuth,
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Michael Archdeacon, MD
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cincinnati, OH
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Columbia, Missouri 65212
Principal Investigator: Brett Crist, MD
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Columbia, MO
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777 Bannock St
Denver, Colorado 80204
(303) 436-6000
Principal Investigator: Joshua Parry, MD
Denver Health Medical Center Denver Health is a comprehensive, integrated organization providing level one care...
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Denver, CO
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Greenville, South Carolina 29605
Principal Investigator: Kyle Jeray, MD
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Greenville, SC
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Irvine, California 92697
Principal Investigator: John Scolaro, MD
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Irvine, CA
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Paul Matuszewski, MD
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Los Angeles, California 90048
Principal Investigator: Charles Moon, MD
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Los Angeles, California 90095
Principal Investigator: Louis Kwong, MD
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Mobile, Alabama 36608
Principal Investigator: Russell Goode, MD
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Mobile, AL
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Morgantown, West Virginia 26506
(304) 293-0111
Principal Investigator: David Hubbard, MD
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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New York, New York 10016
Principal Investigator: Philipp Leucht, MD
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San Antonio, Texas 78229
Principal Investigator: Animesh Agarwal, MD
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San Antonio, TX
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