Clinical trial NCT02820363: Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures
Official title: A Prospective, Randomized Multicenter Controlled Trial of CERAMENT™|G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tibial Fracture
Keywords: wound
open fracture
fracture
tibial
Lead sponsor: BONESUPPORT AB
Sponsor class: INDUSTRY
First posted: 2016-07-01
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 14 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. 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.

Primary outcomes:
measure: Composite of absence of deep infection at fracture site, absence of secondary procedures intended to promote fracture union, and improvement in the SF-36v2 PCS.
timeFrame: 12 months
measure: Serious device related adverse events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Irvine
country: United States
facility: University of California
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Orthopedic
state: California
city: Los Angeles
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Columbia
country: United States
facility: University of Missouri Health
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: New York
country: United States
facility: New York University, Bellevue Hospital
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Greenville
country: United States
facility: Department of Orthopedics Greenville Health System
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth
city: Essen
country: Germany
facility: Essen University Hospital
city: Ludwigshafen
country: Germany
facility: BG Hospital Ludwigshafen
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz
city: Munich
country: Germany
facility: Rechts der Isar Hospital
city: Munich
country: Germany
facility: LMU Munich
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Szczecin
country: Poland
facility: Samodzielny Publiczny Wojewodzki Szpital
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: London
country: United Kingdom
facility: The Royal London Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Imperial College
city: Manchester
country: United Kingdom
facility: University Hospitals
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: The University of Chicago Medicine
name: Douglas R. Dirschl, MD
role: PRINCIPAL_INVESTIGATOR
References: