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TRAUMA:
WHY USE CERAMENT

CERAMENT helps in the management of trauma cases;

Remodels into bone within 6-12 months

Injectable

Flowable

 

Open/complex fractures

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.

 

Closed fractures

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, and offers complete dead space management because it is both injectable and flowable, reducing the risk of infection.

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.

REFERENCES

Lenarz C et al. Timing of wound closure in open fractures based on cultures obtained after debridement. J Bone Joint Surg Am. 2010;92:1921–1926.

Pollak AN et al. The relationship between time to surgical debridement and incidence of infection after open high-energy lower extremity trauma. LEAP Study Group, J Bone Joint Surg Am. 2010 Jan;92(1):7-15.

Zalavras CG et al. Management of open fractures and subsequent complications. J Bone Joint Surg Am. 2007 Apr; 89(4):884-95

Caudle RJ & Stern PJ. Severe open fractures of the tibia. J Bone Joint Surg Am. 1987;69:801–807.

Kim & Leopold. Gustilo-Anderson Classification. Clin Orthop Relat Res. 2012 Nov; 470(11): 3270–3274.

Gustilo RB et al. Classification of type III (severe) open fractures relative to treatment and results. Orthopedics. 1987 Dec;10(12):1781-8.

Young et al. Complications of internal fixation of tibial plateau fractures. Orthopaedic Review. 1994, 23(2):149-154

Dellamonica P, Etesse-Carsenti H, Bernard E, Mondain V, Durant J, Argenson C. Pefloxacin in the treatment of bone infections associated with foreign material. J Antimicrob Chemother. 1990;26(suppl B):199–205

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

CERAMENT®|BONE VOID FILLER Instructions for Use – IFU 0004-08

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