A Randomized Clinical Trial of Biodegradable and Titanium Fixation Systems in Maxillofacial Surgery
| Autor: | Johan Jansma, Rudolf R.M. Bos, Th. J. M. Hoppenreijs, J. E. Bergsma, J. G. A. M. de Visscher, G. J. Buijs, N. B. van Bakelen, Boudewijn Stegenga |
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| Přispěvatelé: | Personalized Healthcare Technology (PHT) |
| Rok vydání: | 2012 |
| Předmět: |
safety
MECHANICAL STRENGTH medicine.medical_specialty DEVICES non-inferior FRACTURE FIXATION medicine.medical_treatment Bone Screws Oral Surgical Procedures Osteotomy Sagittal Split Ramus efficacy Dentistry Biocompatible Materials Effectiveness Bone healing Osteotomy Maxillary Fractures law.invention REMOVAL Randomized controlled trial law Mandibular Fractures Absorbable Implants Fracture fixation Bone plate medicine Humans Osteotomy Le Fort Prospective Studies Prospective cohort study maxillofacial General Dentistry Zygomatic Fractures Fixation (histology) Titanium Wound Healing Chi-Square Distribution STABILITY business.industry POLY(L-LACTIDE) BONE PLATES STIFFNESS Surgery bone-healing Treatment Outcome FOREIGN-BODY REACTIONS SCREWS business Bone Plates |
| Zdroj: | Journal of Dental Research, 91(3), 299-304. SAGE Publications Inc. |
| ISSN: | 1544-0591 0022-0345 |
| DOI: | 10.1177/0022034511434353 |
| Popis: | Biodegradable fixation systems could reduce or delete the problems associated with metallic systems, since removal is not necessary. The aim of this study was to establish the effectiveness and safety of biodegradable plates and screws as potential alternatives to metallic ones. This multi-center randomized controlled trial was conducted from December 2006 to July 2009. Included were patients who underwent mandibular and/or Le Fort I osteotomies and those with fractures of the mandible, maxilla, and zygoma. The patients were assigned to a titanium control group (KLS Martin) or to a biodegradable test group (Inion CPS). The primary outcome measure was ‘bone healing 8 weeks post-operatively’. The Intention-To-Treat (ITT) analysis of 113 patients in the titanium group and 117 patients in the biodegradable group yielded a significant difference (p < 0.001), primarily because in 25 patients (21%) who were randomized to the biodegradable group, the surgeon made the decision to switch to titanium intra-operatively. Despite this ‘inferior’ primary outcome result, biodegradable plates and screws could be safely used when it was possible to apply them. The benefits of using biodegradable systems (fewer plate removal operations) should be confirmed during a follow-up of minimally 5 years ( Controlled-trials.com ISRCTN number 44212338). |
| Databáze: | OpenAIRE |
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