Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures
NCT ID: NCT02820363
Last Updated: 2021-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
201 participants
INTERVENTIONAL
2017-02-14
2021-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Test
Tibial fracture fixation with IM Nail. Apply CERAMENT™\|G applied to bony void(s).
CERAMENT|G
Surgical repair of tibia fracture, CERAMENT™\|G applied to bony voids.
SOC treatment
surgical repair of tibial fracture
Control
Tibial fracture fixation with IM nail.
SOC treatment
surgical repair of tibial fracture
Interventions
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CERAMENT|G
Surgical repair of tibia fracture, CERAMENT™\|G applied to bony voids.
SOC treatment
surgical repair of tibial fracture
Eligibility Criteria
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Exclusion Criteria
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. Previous history of osteomyelitis in the index limb
11. 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.
12. 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.
18 Years
75 Years
ALL
No
Sponsors
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BONESUPPORT AB
INDUSTRY
Responsible Party
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Principal Investigators
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Douglas R. Dirschl, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Chicago Medicine
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California
Irvine, California, United States
University of Southern California
Los Angeles, California, United States
Cedars Sinai Medical Orthopedic
Los Angeles, California, United States
Harbor-UCLA Medical Center
Los Angeles, California, United States
Denver Health Medical Center
Denver, Colorado, United States
University of Chicago
Chicago, Illinois, United States
University of Kentucky
Lexington, Kentucky, United States
University of Missouri Health
Columbia, Missouri, United States
Washington University
St Louis, Missouri, United States
University of New Mexico
Albuquerque, New Mexico, United States
New York University, Bellevue Hospital
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Department of Orthopedics Greenville Health System
Greenville, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Health Science Center
San Antonio, Texas, United States
West Virginia University
Morgantown, West Virginia, United States
Klinikum Bayreuth
Bayreuth, , Germany
Essen University Hospital
Essen, , Germany
BG Hospital Ludwigshafen
Ludwigshafen, , Germany
Universitätsmedizin Mainz
Mainz, , Germany
Rechts der Isar Hospital
Munich, , Germany
LMU Munich
Munich, , Germany
Universitätsklinikum Regensburg
Regensburg, , Germany
Samodzielny Publiczny Wojewodzki Szpital
Szczecin, , Poland
University Hospital Coventry
Coventry, , United Kingdom
The Royal London Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Imperial College
London, , United Kingdom
University Hospitals
Manchester, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Other Identifiers
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CLIN001 - FORTIFY
Identifier Type: -
Identifier Source: org_study_id
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