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

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. Therefor...