Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures

Tibial Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820363
• Other study ID #: CLIN001 - FORTIFY
• Status: Completed
• Phase: N/A
• Start date: February 14, 2017
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2021
• Source: BONESUPPORT AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Fracture
• Tibial Fractures

Intervention

Device:
• CERAMENT|G
Surgical repair of tibia fracture, CERAMENT™|G applied to bony voids.

Procedure:
• SOC treatment
surgical repair of tibial fracture

Locations

Country	Name	City	State
Germany	Klinikum Bayreuth	Bayreuth
Germany	Essen University Hospital	Essen
Germany	BG Hospital Ludwigshafen	Ludwigshafen
Germany	Universitätsmedizin Mainz	Mainz
Germany	LMU Munich	Munich
Germany	Rechts der Isar Hospital	Munich
Germany	Universitätsklinikum Regensburg	Regensburg
Poland	Samodzielny Publiczny Wojewodzki Szpital	Szczecin
United Kingdom	University Hospital Coventry	Coventry
United Kingdom	Imperial College	London
United Kingdom	King's College Hospital	London
United Kingdom	The Royal London Hospital	London
United Kingdom	University Hospitals	Manchester
United Kingdom	Southampton General Hospital	Southampton
United States	University of New Mexico	Albuquerque	New Mexico
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Chicago	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	University of Missouri Health	Columbia	Missouri
United States	Denver Health Medical Center	Denver	Colorado
United States	Department of Orthopedics Greenville Health System	Greenville	South Carolina
United States	University of California	Irvine	California
United States	University of Kentucky	Lexington	Kentucky
United States	Cedars Sinai Medical Orthopedic	Los Angeles	California
United States	Harbor-UCLA Medical Center	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	West Virginia University	Morgantown	West Virginia
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	New York University, Bellevue Hospital	New York	New York
United States	Washington University	Saint Louis	Missouri
United States	University of Texas Health Science Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
BONESUPPORT AB

Countries where clinical trial is conducted

United States,  Germany,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Serious device related adverse events	for the test (CERAMENT™|G) arm	12 months