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Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02820363
Recruitment Status : Recruiting
First Posted : July 1, 2016
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
BONESUPPORT AB

Tracking Information
First Submitted Date  ICMJE June 27, 2016
First Posted Date  ICMJE July 1, 2016
Last Update Posted Date January 13, 2020
Actual Study Start Date  ICMJE February 14, 2017
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
  • 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. [ Time Frame: 12 months ]
    Absence of secondary procedures, absence of infection.
  • Serious device related adverse events [ Time Frame: 12 months ]
    for the test (CERAMENT™|G) arm
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT02820363 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures
Official Title  ICMJE A Prospective, Randomized Multicenter Controlled Trial of CERAMENT™|G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tibial Fracture
Intervention  ICMJE
  • Device: CERAMENT|G
    Surgical repair of tibia fracture, CERAMENT™|G applied to bony voids.
  • Procedure: SOC treatment
    surgical repair of tibial fracture
Study Arms  ICMJE
  • Experimental: Test
    Tibial fracture fixation with IM Nail. Apply CERAMENT™|G applied to bony void(s).
    Interventions:
    • Device: CERAMENT|G
    • Procedure: SOC treatment
  • Active Comparator: Control
    Tibial fracture fixation with IM nail.
    Intervention: Procedure: SOC treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 3, 2016)
230
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Erin Mundstock, BS 781-772-1756 erin.mundstock@bonesupport.com
Listed Location Countries  ICMJE Germany,   Poland,   United Kingdom,   United States
Removed Location Countries Sweden
 
Administrative Information
NCT Number  ICMJE NCT02820363
Other Study ID Numbers  ICMJE CLIN001 - FORTIFY
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party BONESUPPORT AB
Study Sponsor  ICMJE BONESUPPORT AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Douglas R. Dirschl, MD The University of Chicago Medicine
PRS Account BONESUPPORT AB
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP