Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures

BONESUPPORT

Status: Completed

Conditions: Tibial Fracture

Treatments: Device: CERAMENT|G; Procedure: SOC treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT02820363

CLIN001 - FORTIFY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 201 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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201 participants in 2 patient groups

Test

Experimental group

Description:

Tibial fracture fixation with IM Nail. Apply CERAMENT™\|G applied to bony void(s).

Treatment:

Device: CERAMENT|G

Procedure: SOC treatment

Control

Active Comparator group

Description:

Tibial fracture fixation with IM nail.

Treatment:

Procedure: SOC treatment