Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures

NCT02820363 | Completed DMC FDA Device

• 1 other identifier: CLIN001 - FORTIFY
• Study Type: interventional
• Target: 201
• Locations: 4 countries
• Sites: 31

Brief 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.

Conditions

Tibial Fracture

Keywords

wound; open fracture; fracture; tibial

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Test

EXPERIMENTAL

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

Device: CERAMENT|G; Procedure: SOC treatment

Control

ACTIVE COMPARATOR

Tibial fracture fixation with IM nail.

Procedure: SOC treatment

Interventions

CERAMENT|G DEVICE

Surgical repair of tibia fracture, CERAMENT™\|G applied to bony voids.

Test

SOC treatment PROCEDURE

surgical repair of tibial fracture

Control; Test

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• BONESUPPORT AB: lead

Study Sites (31)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3409, United States

Location

University of California

Irvine, California, 62697, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars Sinai Medical Orthopedic

Los Angeles, California, 90048, United States

Location

Harbor-UCLA Medical Center

Los Angeles, California, 90509, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

University of Missouri Health

Columbia, Missouri, 65212, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

New York University, Bellevue Hospital

New York, New York, 10016, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267-0212, United States

Location

Department of Orthopedics Greenville Health System

Greenville, South Carolina, 29605, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Klinikum Bayreuth

Bayreuth, DE-95445, Germany

Location

Essen University Hospital

Essen, 45147, Germany

Location

BG Hospital Ludwigshafen

Ludwigshafen, 67071, Germany

Location

Universitätsmedizin Mainz

Mainz, Germany

Location

Rechts der Isar Hospital

Munich, 81675, Germany

Location

LMU Munich

Munich, Germany

Location

Universitätsklinikum Regensburg

Regensburg, Germany

Location

Samodzielny Publiczny Wojewodzki Szpital

Szczecin, 70-891, Poland

Location

University Hospital Coventry

Coventry, CV 2 2DX, United Kingdom

Location

The Royal London Hospital

London, E1BB, United Kingdom

Location

King's College Hospital

London, SE5 9R, United Kingdom

Location

Imperial College

London, United Kingdom

Location

University Hospitals

Manchester, M23 9LT, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Tibial Fractures; Wounds and Injuries; Fractures, Open; Fractures, Bone

Condition Hierarchy (Ancestors)

Leg Injuries

Study Officials

• Douglas R. Dirschl, MD

  The University of Chicago Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 1, 2016
• Study Start: February 14, 2017
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (6); US (17); DE (7); PL (1)