Open fractures are one of the most common causes of a patient developing a bone infection and include the risk of re-fracture and non-union.
A recent clinical study supports the use of CERAMENT® G in this indication. Henry et al. (2023) demonstrated very low rates of deep infection (3.7%) for open Gustilo-Anderson IIIB fractures(1) – a significant improvement over the standard of care (weighted mean infection rate of 14.5%)(2-6).
CERAMENT G also compared favorably to standard of care in terms of limb salvage (96.3%)(1) and bone union (96%)(1).
For these and other open fractures in the extremities of skeletally mature patients, CERAMENT G is FDA 510(k) cleared for use as part of the standard treatment approach, reducing the occurrence and recurrence of bone infection in order to promote and protect bone healing. FDA cleared, indicated use of CERAMENT G in open fractures is the first and only of its kind.
- Henry JA, Ali A, Elkhidir IH, Reid A, Wong J, Pillai A. Long-Term Follow-Up of Open Gustilo-Anderson IIIB Fractures Treated With an Adjuvant Local Antibiotic Hydroxyapatite Bio-Composite. Cureus. 2023 May 16;15(5):e39103. doi: 10.7759/cureus.39103. PMID: 37332443; PMCID: PMC10270668.
- Major Extremity Trauma Research Consortium. (2022). Modern external ring fixation versus internal fixation for treatment of severe open tibial fractures: a randomized clinical trial (FIXIT Study). JBJS, 104(12), 1061-1067.
- Al-Hourani, K., Stoddart, M., Khan, U., Riddick, A., & Kelly, M. (2019). Orthoplastic reconstruction of type IIIB open tibial fractures retaining debrided devitalized cortical segments: the Bristol experience 2014 to 2018. The bone & joint journal, 101-B(8), 1002–1008. https://doi.org/10.1302/0301-620X.101B8.BJJ-2018-1526.R2
- Su, C. A., Nguyen, M. P., O’Donnell, J. A., & Vallier, H. A. (2018). Outcomes of tibia shaft fractures caused by low energy gunshot wounds. Injury, 49(7), 1348–1352. https://doi.org/10.1016/j.injury.2018.05.006
- Hendrickson, S. A., Wall, R. A., Manley, O., Gibson, W., Toher, D., Wallis, K., … & Khan, U. (2018). Time to Initial Debridement and wound Excision (TIDE) in severe open tibial fractures and related clinical outcome: A multi-centre study. Injury, 49(10), 1922-1926.
- Papakostidis, C., Kanakaris, N. K., Pretel, J., Faour, O., Morell, D. J., & Giannoudis, P. V. (2011). Prevalence of complications of open tibial shaft fractures stratified as per the Gustilo-Anderson classification. Injury, 42(12), 1408–1415. https://doi.org/10.1016/j.injury.2011.10.015
Please have a look at our materials below on how to use CERAMENT G for best outcomes, example cases and clinical results.
