An interventional study of bioglass (S53P4) and RIA and TCP in Pseudoarthrosis of Bone, sponsored by Sebastian Findeisen. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-20.
Sponsored by Sebastian Findeisen · Not applicable, Interventional, and Treatment
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.
41 studies on the registry are indexed under Pseudarthrosis; 7 are open to participants now.
This study's planned enrollment of 50 is above the median of 22 across 25 interventional studies indexed under Pseudarthrosis.
Browse Pseudarthrosis studies →This is the only study on the registry with Sebastian Findeisen as lead sponsor.
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Exclusion Criteria:
Device: bioglass (S53P4)
Device: RIA and TCP
surgical procedure: Masquelet defect augmentation with bioglass
surgical procedure: Masquelet defect augmentation with RIA and TCP
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
Time frame: 1 year post-operative Masquelet step II
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)
Time frame: 1 year post-operative Masquelet step II
Perfusion
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
Time frame: 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
Time frame: 1 year post-operative Masquelet step II
Plan to share: Yes — anonymized/pseudonymized, data that underlies results in a publication
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: after conclusion and evaluation of the study
Access criteria: public
Data sharing details ↗ · pubmed.ncbi.nlm.nih.gov
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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