Clinical trial NCT05049915 - References

Pseudoarthrosis of Bone — Evaluation of the Clinical Effectiveness of Bioactive Glass (S53P4) in the Treatment of Tibia and Femur Non-unions

Citation(s)

•   Einhorn TA
  The cell and molecular biology of fracture healing. Clin Orthop Relat Res. 1998 Oct;(355 Suppl):S7-21.
•   Fischer C, Frank M, Kunz P, Tanner M, Weber MA, Moghaddam A, Schmidmaier G, Hug A
  Dynamic contrast-enhanced ultrasound (CEUS) after open and minimally invasive locked plating of proximal humerus fractures. Injury. 2016 Aug;47(8):1725-31. doi: 10.1016/j.injury.2016.05.005. Epub 2016 May 14.
•   Fischer C, Nissen M, Schmidmaier G, Bruckner T, Kauczor HU, Weber MA
  Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) for the prediction of non-union consolidation. Injury. 2017 Feb;48(2):357-363. doi: 10.1016/j.injury.2017.01.021. Epub 2017 Jan 9.
•   Fischer C, Preuss EM, Tanner M, Bruckner T, Krix M, Amarteifio E, Miska M, Moghaddam-Alvandi A, Schmidmaier G, Weber MA
  Dynamic Contrast-Enhanced Sonography and Dynamic Contrast-Enhanced Magnetic Resonance Imaging for Preoperative Diagnosis of Infected Nonunions. J Ultrasound Med. 2016 May;35(5):933-42. doi: 10.7863/ultra.15.06107. Epub 2016 Apr 1.
•   Giannoudis PV, Einhorn TA, Marsh D
  Fracture healing: the diamond concept. Injury. 2007 Sep;38 Suppl 4:S3-6. Review.
•   Hak DJ, Fitzpatrick D, Bishop JA, Marsh JL, Tilp S, Schnettler R, Simpson H, Alt V
  Delayed union and nonunions: epidemiology, clinical issues, and financial aspects. Injury. 2014 Jun;45 Suppl 2:S3-7. doi: 10.1016/j.injury.2014.04.002. Review.
•   Haubruck P, Kammerer A, Korff S, Apitz P, Xiao K, Büchler A, Biglari B, Zimmermann G, Daniel V, Schmidmaier G, Moghaddam A
  The treatment of nonunions with application of BMP-7 increases the expression pattern for angiogenic and inflammable cytokines: a matched pair analysis. J Inflamm Res. 2016 Sep 22;9:155-165. eCollection 2016.
•   Kankare J, Lindfors NC
  Reconstruction of Vertebral Bone Defects using an Expandable Replacement Device and Bioactive Glass S53P4 in the Treatment of Vertebral Osteomyelitis: Three Patients and Three Pathogens. Scand J Surg. 2016 Dec;105(4):248-253. doi: 10.1177/1457496915626834. Epub 2016 Jun 23.
•   Kokubo T, Takadama H
  How useful is SBF in predicting in vivo bone bioactivity? Biomaterials. 2006 May;27(15):2907-15. Epub 2006 Jan 31. Review.
•   Lindfors N, Geurts J, Drago L, Arts JJ, Juutilainen V, Hyvönen P, Suda AJ, Domenico A, Artiaco S, Alizadeh C, Brychcy A, Bialecki J, Romanò CL
  Antibacterial Bioactive Glass, S53P4, for Chronic Bone Infections - A Multinational Study. Adv Exp Med Biol. 2017;971:81-92. doi: 10.1007/5584_2016_156. Erratum in: Adv Exp Med Biol. 2017;971:115-116.
•   Lindfors NC, Hyvönen P, Nyyssönen M, Kirjavainen M, Kankare J, Gullichsen E, Salo J
  Bioactive glass S53P4 as bone graft substitute in treatment of osteomyelitis. Bone. 2010 Aug;47(2):212-8. doi: 10.1016/j.bone.2010.05.030.
•   Moghaddam A, Breier L, Haubruck P, Bender D, Biglari B, Wentzensen A, Zimmermann G
  Non-unions treated with bone morphogenic protein 7: introducing the quantitative measurement of human serum cytokine levels as promising tool in evaluation of adjunct non-union therapy. J Inflamm (Lond). 2016 Jan 22;13:3. doi: 10.1186/s12950-016-0111-x. eCollection 2016.
•   Romanò CL, Logoluso N, Meani E, Romanò D, De Vecchi E, Vassena C, Drago L
  A comparative study of the use of bioactive glass S53P4 and antibiotic-loaded calcium-based bone substitutes in the treatment of chronic osteomyelitis: a retrospective comparative study. Bone Joint J. 2014 Jun;96-B(6):845-50. doi: 10.1302/0301-620X.96B6.33014.
•   Schmidmaier G, Moghaddam A
  [Long Bone Nonunion]. Z Orthop Unfall. 2015 Dec;153(6):659-74; quiz 675-6. doi: 10.1055/s-0035-1558259. Epub 2015 Dec 15. German.
•   Stoor P, Apajalahti S, Kontio R
  Regeneration of Cystic Bone Cavities and Bone Defects With Bioactive Glass S53P4 in the Upper and Lower Jaws. J Craniofac Surg. 2017 Jul;28(5):1197-1205. doi: 10.1097/SCS.0000000000003649.
•   Stoor P, Pulkkinen J, Grénman R
  Bioactive glass S53P4 in the filling of cavities in the mastoid cell area in surgery for chronic otitis media. Ann Otol Rhinol Laryngol. 2010 Jun;119(6):377-82.
•   Tanner MC, Heller R, Westhauser F, Miska M, Ferbert T, Fischer C, Gantz S, Schmidmaier G, Haubruck P
  Evaluation of the clinical effectiveness of bioactive glass (S53P4) in the treatment of non-unions of the tibia and femur: study protocol of a randomized controlled non-inferiority trial. Trials. 2018 May 30;19(1):299. doi: 10.1186/s13063-018-2681-9.
•   Välimäki VV, Aro HT
  Molecular basis for action of bioactive glasses as bone graft substitute. Scand J Surg. 2006;95(2):95-102. Review.
•   van Gestel NA, Geurts J, Hulsen DJ, van Rietbergen B, Hofmann S, Arts JJ
  Clinical Applications of S53P4 Bioactive Glass in Bone Healing and Osteomyelitic Treatment: A Literature Review. Biomed Res Int. 2015;2015:684826. doi: 10.1155/2015/684826. Epub 2015 Oct 4. Review.

Evaluation of the Clinical Effectiveness of Bioactive Glass (S53P4) in the Treatment of Non-unions of the Tibia and Femur: a Randomized Controlled Non-inferiority Trial

Details for clinical trial NCT05049915