Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures
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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 :
Active, not recruiting
First Posted : July 1, 2016
Last Update Posted : January 27, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tibial Fracture | Device: CERAMENT|G Procedure: SOC treatment | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 230 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 |
Estimated Primary Completion Date : | August 2021 |
Estimated Study Completion Date : | August 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Test
Tibial fracture fixation with IM Nail. Apply CERAMENT™|G applied to bony void(s).
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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.
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Procedure: SOC treatment
surgical repair of tibial fracture |
- 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

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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 |
- 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 10 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
- Inadequate neurovascular status in the involved limb that may jeopardize healing (e.g., Gustilo-Anderson IIIc classification)
- 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.

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

Principal Investigator: | Douglas R. Dirschl, MD | The University of Chicago Medicine |
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: | January 27, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
wound open fracture fracture tibial |
Fractures, Bone Tibial Fractures Wounds and Injuries Leg Injuries |