All open fractures are contaminated by exposure to the outside environment, and the more severe the soft tissue damage, the worse the clinical prognosis for infection, wound complications, non-union and amputation. The objectives of surgical treatment are to prevent infection, achieve union and restore function.
Fractures requiring open reduction internal fixation (ORIF) commonly have four main complications: non-union, re-fracture, implant failure and infection.
Deep infections cannot be cured in the presence of hardware, but removing hardware in the presence of an unhealed fracture greatly complicates management of the infection and the fracture.
In either open or ORIF cases, high-risk patients, such as those with diabetes and rheumatoid arthiritis, are at increased risk of wound complications, infection and failure of fixation.
CERAMENT remodels into bone within 6-12 months, reducing the risk of non-union or re-fracture, offers complete dead space management because it is both injectable and flowable, reducing the risk of infection; and can provide a high local concentration of antibiotic in CERAMENT| G and CERAMENT V, when needed.
BONESUPPORT AB is funding a multi-centre randomised controlled trial comparing CERAMENT™|BONE VOID FILLER to autologous bone in the treatment of tibial plateau fractures, for which enrolment is due to be finished in 2017.
For more information about this trial, please click here
BONESUPPORT AB is funding a prospective, multi-centre randomised controlled trial to demonstrate the safety and effectiveness of CERAMENT™|G used in conjunction with standard-of-care treatment compared to standard-of-care treatment alone for patients with open fractures of the tibial diaphysis. Enrolment completion is anticipated in 2019. For more information about this trial, please click here.
BONESUPPORT AB is participating in the Baltic Fracture Competence Center (BFCC) project. The BFCC will develop and implement a transnational fracture registry of six hospitals from Denmark, Estonia, Germany, Lithuania, Poland, and Sweden providing evidence about fracture treatment in the clinical “real world” and reveal clinical needs and potentials for innovation. The collaboration between hospitals across countries will foster the innovation of clinical procedures through the exchange of best practice in fracture management influenced by different national, organisational and regulatory conditions.
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Nilsson et al. The composite of hydroxyapatite and calcium sulphate: a review of preclinical evaluation and clinical applications. Expert Rev. Med. Devices 10(5), 675-684, 2013
CERAMENT®|BONE VOID FILLER Bone healing technical monograph - PR 0278-01
EN CERAMENT®|BONE VOID FILLER Instructions for Use – IFU 0004-08
CERAMENT®|G Instructions for Use – IFU 0014-02
CERAMENT®|V Instructions for use - IFU0016-02
Abramo et al. Osteotomy of dorsally displaced malunited fractures of the distal radius: No loss of radiographic correction during healing with a minimally invasive fixation technique and an injectable bone substitute. Acta Orthop 79:262-268, 2008
Bark et al. Case Report: Arthroscopic-Assisted Treatment of a Reversed Hill-Sachs Lesion: Description of a New Technique Using CERAMENT®. Case Reports in Orthopedics, Volume 2015, Article ID 789203, 5 pages. http://dx.doi.org/10.1155/2015/789203
Kaczmarczyk et al. Complete twelve month bone remodeling with a bi-phasic injectable bone substitute in benign bone tumors: a prospective pilot study. BMC Musculoskeletal Disorders (2015) 16:369. DOI 10.1186/s12891-015-0828-3