ArticleTrials2018
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.
Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies: A Non- Inferiority Randomized Clinical Trial
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
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A systematic review on bioactive glass as a treatment for limb osteomyelitis and infected nonunion.Bone & joint open · 2025Pooled it
- Current Advancements in Bone Grafting Substitutes for Osteoporotic Distal Tibia Fractures: A Narrative Review of Beta-Tricalcium Phosphate (Neobone™) and Demineralized Bone Matrix.Medicina (Kaunas, Lithuania) · 2026Review
- Time to consider fracture nonunion an orphan disease? An update into pathophysiology, epidemiology and therapeutic solutions.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2025Review
- Engineering the bone reconstruction surgery: the case of the masquelet-induced membrane technique.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2025Review
- Treatment of Bone Defects and Nonunion via Novel Delivery Mechanisms, Growth Factors, and Stem Cells: A Review.ACS biomaterials science & engineering · 2024Review
- Use of Autologous Bone Graft with Bioactive Glass as a Bone Substitute in the Treatment of Large-Sized Bone Defects of the Femur and Tibia.Journal of personalized medicine · 2023Article
- Matched-Pair Analysis: Large-Sized Defects in Surgery of Lower Limb Nonunions.Journal of clinical medicine · 2023Article
- Treatment of Infection-Related Non-Unions with Bioactive Glass-A Promising Approach or Just Another Method of Dead Space Management?Materials (Basel, Switzerland) · 2022Article
- Saving the lower limb with GlassBONE™ - Successful surgical revision of pseudarthrosis after infected open proximal tibia fracture type IIIC with bioactive glass grafting - A case report.Trauma case reports · 2021Article
- Bioactive Glass and Silicate-Based Ceramic Coatings on Metallic Implants: Open Challenge or Outdated Topic?Materials (Basel, Switzerland) · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
backgroundTreatment 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. METHODS/
designThis 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.
trial registrationGerman Clinical Trials Register (DRKS), ID: DRKS00013882 . Registered on 22 January 2018.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.