Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures

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.

Study Overview

• Status: Completed
• Conditions: Tibial Fracture
• Intervention / Treatment: Device: CERAMENT|G; Procedure: SOC treatment

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 Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bayreuth, Germany, DE-95445
    • Klinikum Bayreuth
  • Essen, Germany, 45147
    • Essen University Hospital
  • Ludwigshafen, Germany, 67071
    • BG Hospital Ludwigshafen
  • Mainz, Germany
    • Universitätsmedizin Mainz
  • Munich, Germany, 81675
    • Rechts der Isar Hospital
  • Munich, Germany
    • LMU Munich
  • Regensburg, Germany
    • Universitätsklinikum Regensburg
• Poland
  • Szczecin, Poland, 70-891
    • Samodzielny Publiczny Wojewodzki Szpital
• United Kingdom
  • Coventry, United Kingdom, CV 2 2DX
    • University Hospital Coventry
  • London, United Kingdom
    • Imperial College
  • London, United Kingdom, E1BB
    • The Royal London Hospital
  • London, United Kingdom, SE5 9R
    • King's College Hospital
  • Manchester, United Kingdom, M23 9LT
    • University Hospitals
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-3409
      • University of Alabama at Birmingham
  • California
    • Irvine, California, United States, 62697
      • University of California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Orthopedic
    • Los Angeles, California, United States, 90509
      • Harbor-UCLA Medical Center
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University Of Kentucky
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico
  • New York
    • New York, New York, United States, 10016
      • New York University, Bellevue Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0212
      • University of Cincinnati
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Department of Orthopedics Greenville Health System
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: BONESUPPORT AB
• Investigators: Principal Investigator: Douglas R. Dirschl, MD, The University of Chicago Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2017
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): July 1, 2016

Study Record Updates

• Last Update Posted (Actual): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: fracture; wound; open fracture; tibial
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: CLIN001 - FORTIFY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes