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

• Published in: Current controlled trials in cardiovascular medicine Vol. 19; no. 1; pp. 299 - 9
• Main Authors: Tanner, Michael C, Heller, Raban, Westhauser, Fabian, Miska, Matthias, Ferbert, Thomas, Fischer, Christian, Gantz, Simone, Schmidmaier, Gerhard, Haubruck, Patrick
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 30.05.2018; BioMed Central; BMC
• Subjects: Autografts; Bioactive glass; Biological products; Bone marrow; Bone Regeneration; Bone Substitutes - adverse effects; Bone Substitutes - therapeutic use; Bone surgery; Bone transplantation; Bone Transplantation - adverse effects; Bone Transplantation - methods; Care and treatment; Defects; Equivalence Trials as Topic; Femoral Fractures - diagnostic imaging; Femoral Fractures - physiopathology; Femoral Fractures - surgery; Fracture Healing; Fractures; Fractures, Ununited - diagnostic imaging; Fractures, Ununited - physiopathology; Fractures, Ununited - surgery; Germany; Glass; Humans; Joint diseases; Magnetic resonance imaging; Masquelet therapy; Medical imaging; Non-union; Osseointegration; Patient outcomes; Patients; Prospective Studies; Pseudarthrosis; Quality of life; S53P4; Skin & tissue grafts; Stem cells; Study Protocol; Substance abuse treatment; Tibial Fractures - diagnostic imaging; Tibial Fractures - physiopathology; Tibial Fractures - surgery; Time Factors; Trauma; Treatment Outcome; Ultrasonic imaging; X-rays; Germany; Bioactive glass; Bone regeneration; Non-union; Bone grafting; Masquelet therapy; Pseudarthrosis; S53P4
• DOI: 10.1186/s13063-018-2681-9
• ISSN: 1745-6215

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, we 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. 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. 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. German Clinical Trials Register (DRKS), ID: DRKS00013882 . Registered on 22 January 2018.