Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Randomized Multicenter Controlled Trial of CERAMENT™|G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures

Conditions
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Tibial Fracture

Intervention / Treatment
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* Device: CERAMENT|G
* Procedure: SOC treatment


Participation Criteria
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Eligibility Criteria
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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 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 Bone loss at the fracture site must have a radiographic apparent bone gap (RABG) between 3 and 27.5 millimeters. Life expectancy of at least 1 year 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 Adequate soft tissue coverage at the fracture site (through primary closure or surgical reconstruction, including local and free soft tissue transfer) Definitive wound closure within 14 days of the initial injury 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: Pregnant or breastfeeding women or planning on becoming pregnant during the investigational period Patient is currently participating in an investigational drug or other device study or previously enrolled in this study Renal failure or documented chronic kidney disease with serum creatinine ≥3.5 mg/L or being treated with dialysis Known hypersensitivity to aminoglycoside antibiotics, calcium sulfate or calcium hydroxyapatite Pre-existing calcium metabolism disorder Uncontrolled diabetes mellitus (hemoglobin A1c levels > 10%) 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) Neuromuscular disorders such as myasthenia gravis or Parkinson's disease Currently has untreated malignant neoplasm(s), or is currently undergoing radiation therapy or chemotherapy Previous history of osteomyelitis in the index limb 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Tibial fracture fixation with IM Nail. Apply CERAMENT™|G applied to bony void(s). | Device: CERAMENT|G<br>* Surgical repair of tibia fracture, CERAMENT™|G applied to bony voids.<br>Procedure: SOC treatment<br>* surgical repair of tibial fracture<br>|
| Active Comparator: Control<br>Tibial fracture fixation with IM nail. | Procedure: SOC treatment<br>* surgical repair of tibial fracture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Absence of secondary procedures, absence of infection. | 12 months | 
| Serious device related adverse events | for the test (CERAMENT™|G) arm | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound, open fracture, fracture, tibial