Tibial FractureNCT02820363
Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures
A study testing CERAMENT|G and SOC treatment in people with Tibial Fracture, run by BONESUPPORT AB at 31 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tibial Fracture
- What is being tested?
- CERAMENT|G and SOC treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 31 sitesin 4 countries
- Study dates
- 14 Feb 2017to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
31 sites in 4 countries.
31 sites in 4 countries
United States17 sites
University of New Mexico
Albuquerque, New Mexico, 87106
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3409
University of Chicago
Chicago, Illinois, 60637
University of Cincinnati
Cincinnati, Ohio, 45267-0212
University of Missouri Health
Columbia, Missouri, 65212
Denver Health Medical Center
Denver, Colorado, 80204
Department of Orthopedics Greenville Health System
Greenville, South Carolina, 29605
University of California
Irvine, California, 62697
University of Kentucky
Lexington, Kentucky, 40536
University of Southern California
Los Angeles, California, 90033
Cedars Sinai Medical Orthopedic
Los Angeles, California, 90048
Harbor-UCLA Medical Center
Los Angeles, California, 90509
West Virginia University
Morgantown, West Virginia, 26506
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
New York University, Bellevue Hospital
New York, New York, 10016
University of Texas Health Science Center
San Antonio, Texas, 78229
Washington University
St Louis, Missouri, 63110
Germany7 sites
Klinikum Bayreuth
Bayreuth, DE-95445
Essen University Hospital
Essen, 45147
BG Hospital Ludwigshafen
Ludwigshafen, 67071
Universitätsmedizin Mainz
Mainz
Rechts der Isar Hospital
Munich, 81675
LMU Munich
Munich
Universitätsklinikum Regensburg
Regensburg
United Kingdom6 sites
University Hospital Coventry
Coventry, CV 2 2DX
The Royal London Hospital
London, E1BB
King's College Hospital
London, SE5 9R
Imperial College
London
University Hospitals
Manchester, M23 9LT
Southampton General Hospital
Southampton, SO16 6YD
About this study
Official title: A Prospective, Randomized Multicenter Controlled Trial of CERAMENT™|G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures
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.
Read the 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.
- Conditions
- Tibial Fracture
- Being tested
- CERAMENT|G, SOC treatment
- Keywords
- wound, open fracture, fracture, tibial
- Medical subject headings
- Tibial Fractures, Wounds and Injuries, Fractures, Open, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CERAMENT|GDevice
Surgical repair of tibia fracture, CERAMENT™|G applied to bony voids.
SOC treatmentProcedure or surgery
surgical repair of tibial fracture
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Tibial fracture fixation with IM Nail. Apply CERAMENT™|G applied to bony void(s). Receives: Device: CERAMENT|G; Procedure: SOC treatment |
| Control | Active comparator | Tibial fracture fixation with IM nail. Receives: Procedure: SOC treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Serious device related adverse events
for the test (CERAMENT™|G) arm
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study start14 Feb 2017
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- BONESUPPORT AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas R. Dirschl, MD, Principal investigator, The University of Chicago Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820363
- Sponsor's protocol ID
- CLIN001 - FORTIFY
- Status last verified
- Aug 2021
- First submitted
- 27 Jun 2016
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Multicenter Controlled Trial of CERAMENT™|G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures
- ClinicalTrials.gov ID
- NCT02820363
- Acronym / sponsor ID
- CLIN001 - FORTIFY
- Conditions
- Tibial Fracture
- Keywords
- wound, open fracture, fracture, tibial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- BONESUPPORT ABIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Device: CERAMENT|G, Procedure: SOC treatmentTibial fracture fixation with IM Nail. Apply CERAMENT™|G applied to bony void(s). |
| Control | Active comparator | Procedure: SOC treatmentTibial fracture fixation with IM nail. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CERAMENT|GSurgical repair of tibia fracture, CERAMENT™|G applied to bony voids. | Device | Test |
| SOC treatmentsurgical repair of tibial fracture | Procedure or surgery | Control, Test |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Tibial Fracture
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Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas R. Dirschl, MD principal investigator
The University of Chicago Medicine
31 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CERAMENT|G and SOC treatment in people with Tibial Fracture, run by BONESUPPORT AB at 31 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Germany, United Kingdom, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.