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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Test
Tibial fracture fixation with IM Nail. Apply CERAMENT™|G applied to bony void(s).
  • Device: CERAMENT|G
    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

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536

More Details

NCT ID
NCT02820363
Status
Recruiting
Sponsor
BONESUPPORT AB

Study Contact

Erin Mundstock, BS
781-772-1756
erin.mundstock@bonesupport.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.