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| Name | Class |
|---|---|
| Bonalive Biomaterials Ltd | INDUSTRY |
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Abstract Background: Treatment of non-union remains challenging and often necessitates augmentation of the resulting defect with an autologous bone graft (ABG). ABG is limited in quantity and its harvesting incurs an additional surgical intervention leaving the risk for associated complications and morbidities. Therefore, artificial bone graft substitutes that might replace autologous bone are needed. S53P4-type bioactive glass (BaG) is a promising material which might be used as bone graft substitute due to its osteostimulative, conductive and antimicrobial properties. In this study, the investigators plan to examine the clinical effectiveness of BaG as a bone graft substitute in Masquelet therapy in comparison with present standard Masquelet therapy using an ABG with tricalciumphosphate to fill the bone defect.
Methods/design: This randomized controlled, clinical non-inferiority trial will be carried out at the Department of Orthopedics and Traumatology at Heidelberg University. Patients who suffer from tibial or femoral non-unions with a segmental bone defect of 2-5 cm and who are receiving Masquelet treatment will be included in the study. The resulting bone defect will either be filled with autologous bone and tricalciumphosphate (control group, N = 25) or BaG (S53P4) (study group, N = 25). Subsequent to operative therapy, all patients will receive the same standardized follow-up procedures. The primary endpoint of the study is union achieved 1year after surgery.
Discussion: The results from the current study will help evaluate the clinical effectiveness of this promising biomaterial in non-union therapy. In addition, this randomized trial will help to identify potential benefits and limitations regarding the use of BaG in Masquelet therapy. Data from the study will increase the knowledge about BaG as a bone graft substitute as well as identify patients possibly benefiting from Masquelet therapy using BaG and those who are more likely to fail, thereby improving the quality of non-union treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Masquelet technique: bioactive glass | Experimental |
| |
| Masquelet technique: RIA + TCP | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bioglass (S53P4) | Device | surgical procedure: Masquelet defect augmentation with bioglass |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of participants with osseus consolidation evaluation via x-ray | x-ray in 2 planes; union = cortical bridging of at least three out of four cortices | 1 year post-operative Masquelet step II |
| Measure | Description | Time Frame |
|---|---|---|
| 12-item Short Form Survey (SF-12) | Quality of life: Physical Score 23.99938(lowest/worst)-56.57706(highest/best), Mental Score 19.06444(lowest/worst)-60.75781 (highest/best) | 1 year post-operative Masquelet step II |
| Perfusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastian Findeisen, Dr. med. | Contact | +4962215634330 | sebastian.findeisen@med.uni-heidelberg.de | |
| Patrick Haubruck, Dr. med. | Contact | patrick.haubruck@med.uni-heidelberg.de |
| Name | Affiliation | Role |
|---|---|---|
| Gerhard Schmidmaier, Prof. Dr. | HTRG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Heidelberg | Recruiting | Heidelberg | Baden-Wurttemberg | 69118 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9917622 | Background | Einhorn TA. The cell and molecular biology of fracture healing. Clin Orthop Relat Res. 1998 Oct;(355 Suppl):S7-21. doi: 10.1097/00003086-199810001-00003. | |
| 26670151 | Background | 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. |
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anonymized/pseudonymized, data that underlies results in a publication
after conclusion and evaluation of the study
public
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 16, 2017 | Sep 9, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D011863 | Radioimmunoassay |
| ID | Term |
|---|---|
| D003947 | Diagnostic Techniques, Radioisotope |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007118 | Immunoassay |
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| RIA and TCP | Device | surgical procedure: Masquelet defect augmentation with RIA and TCP |
|
Real-time microperfusion assessment using Contrast enhanced ultra-sound (CEUS), contrasting agent: SonoVue. Objective perfusion quantification (using VueBox). Evaluation of characteristic perfusion parameters such as: wash-in rate, wash-in perfusion index
| 3 months post-operative Masquelet step II |
| Rate of participants with osseus consolidation evaluation via CT | union = cortical bridging of at least three out of four cortices | 1 year post-operative Masquelet step II |
| 24857025 | Background | 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. |
| 18224731 | Background | Giannoudis PV, Einhorn TA, Marsh D. Fracture healing: the diamond concept. Injury. 2007 Sep;38 Suppl 4:S3-6. doi: 10.1016/s0020-1383(08)70003-2. |
| 24891588 | Background | Romano CL, Logoluso N, Meani E, Romano 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. |
| 16821652 | Background | Valimaki VV, Aro HT. Molecular basis for action of bioactive glasses as bone graft substitute. Scand J Surg. 2006;95(2):95-102. doi: 10.1177/145749690609500204. |
| 28050878 | Background | Lindfors N, Geurts J, Drago L, Arts JJ, Juutilainen V, Hyvonen P, Suda AJ, Domenico A, Artiaco S, Alizadeh C, Brychcy A, Bialecki J, Romano 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. |
| 20624692 | Background | Lindfors NC, Hyvonen P, Nyyssonen 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. |
| 26504821 | Background | 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. |
| 16448693 | Background | Kokubo T, Takadama H. How useful is SBF in predicting in vivo bone bioactivity? Biomaterials. 2006 May;27(15):2907-15. doi: 10.1016/j.biomaterials.2006.01.017. Epub 2006 Jan 31. |
| 28538076 | Background | 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. |
| 20583735 | Background | Stoor P, Pulkkinen J, Grenman 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. doi: 10.1177/000348941011900603. |
| 26929284 | Background | 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. |
| 27242329 | Background | 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. |
| 27036169 | Background | 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. |
| 28088373 | Background | 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. |
| 27703392 | Background | Haubruck P, Kammerer A, Korff S, Apitz P, Xiao K, Buchler 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. doi: 10.2147/JIR.S110621. eCollection 2016. |
| 26807043 | Background | 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. |
| 29843766 | Background | 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. |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D015336 | Molecular Probe Techniques |