FORTIFY Clinical Trial
Research type
Research Study
Full title
A Prospective, Randomized, Multicenter Controlled Trial of CERAMENT™|G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures.
IRAS ID
213821
Contact name
Nima Heidari
Contact email
Sponsor organisation
BONESUPPORT AB
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
G160150, FDA IDE Submission
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
The FORTIFY study is being conducted to evaluate the safety and effectiveness of CERAMENT™|G as an artificial bone graft to help treat open tibial (shinbone) fractures. An open fracture is when bone fragments stick out through the skin, and therefore at high risk of bacterial contamination. This contamination can lead to serious infections in the bone or surrounding tissues, and possibly delay or prevent the bone from healing. Oral or intravenous antibiotics may not be able to get to the fracture site to prevent infection.
Another problem with open fractures can be a loss of some bone at the fracture site, leaving a gap between the 2 sections of normal bone, which may not fill in on its own.
CERAMENT™|G may help solve both of those problems by filling the bone gap, and delivering local antibiotics to prevent infection. CERAMENT™|G is an artificial bone graft substitute that includes an antibiotic, gentamicin.
Up to 230 patients will be randomized in the Study worldwide (U.S. and Europe). To be eligible for enrollment, patients must be between the ages of 18 and 75 and have a tibia fracture that will be fixed with a “nail” through the center of the bone. Study patients will be treated with the current standard surgical and medical care given to patients with open tibia fracture. Half of the patients will also be treated with CERAMENT™|G at the site of the bone gap. The patients in this latter group, the “test group” will be selected in a randomized fashion.
Follow-up visits will occur at 6, 12, 18, 24, 39, and 52 weeks post-procedure. The required tests and activities for this study include exam of the leg fracture, Quality of Life Questionnaires, leg X-rays and blood sample for kidney function testing at 6 and 12 weeks.REC name
London - Queen Square Research Ethics Committee
REC reference
17/LO/0182
Date of REC Opinion
28 Mar 2017
REC opinion
Further Information Favourable Opinion