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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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02820363
Recruitment Status : Completed
First Posted : July 1, 2016
Last Update Posted : August 10, 2021
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Tibial Fracture Device: CERAMENT|G Procedure: SOC treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Multicenter Controlled Trial of CERAMENT™|G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures
Actual Study Start Date : February 14, 2017
Actual Primary Completion Date : July 31, 2021
Actual Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Test
Tibial fracture fixation with IM Nail. Apply CERAMENT™|G applied to bony void(s).
Surgical repair of tibia fracture, CERAMENT™|G applied to bony voids.

Procedure: SOC treatment
surgical repair of tibial fracture

Active Comparator: Control
Tibial fracture fixation with IM nail.
Procedure: SOC treatment
surgical repair of tibial fracture

Primary Outcome Measures :
  1. 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.

  2. Serious device related adverse events [ Time Frame: 12 months ]
    for the test (CERAMENT™|G) arm

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820363

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Sponsors and Collaborators
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Principal Investigator: Douglas R. Dirschl, MD The University of Chicago Medicine
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Responsible Party: BONESUPPORT AB
ClinicalTrials.gov Identifier: NCT02820363    
Other Study ID Numbers: CLIN001 - FORTIFY
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by BONESUPPORT AB:
open fracture
Additional relevant MeSH terms:
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Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries