title: Decision-making considerations in application of biodegradable fixation systems in maxillofacial surgery--a retrospective cohort study.
abstract: In a recent RCT comparing biodegradable (Inion CPS) with titanium (KLS Martin) plates and screws for fixation of osteotomies or fractures, we found that in 21% of the cases the surgeon decided intra-operatively to switch from biodegradable to titanium. The aim of the current retrospective cohort study was to analyse the reasons for these switches in order to find predictor variables that may be helpful in the decision to use biodegradable devices or not. The surgeons' opinion about the biodegradable system, and if there was a learning curve in the application of the biodegradable system were also investigated. All variables were assessed during the original RCT by using a questionnaire that was completed by the OMF surgeon directly post-operatively. For the outcome variable "surgeons' opinion" a separate questionnaire was used. Regarding the predictor variables a mandibular fracture had a higher risk of switching compared to a BSSO. However, looking at the reasons for these switches no firm conclusions can be drawn. There was a subjective learning curve to acquire the application-skills for the biodegradable system. There were no changes in isolated Le-Fort-I osteotomies despite the fact that the biodegradable system seems more difficult to apply in the midface. Inadequate stability was the main reason for switching. This can be material-related, or related to inexperience with or lack of confidence in the system, or impatience of the surgeon. A learning curve and personal preferences probably play an important role in the decision to switch. We think that with more patience and more experience it should be possible to increase both user comfort and confidence in the biodegradable system of Inion CPS, which likely will decrease the number of intra-operative switches.
authors.affiliation: Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, P.O. Box 30.001, 9700 RB Groningen, The Netherlands. Electronic address: n.b.van.bakelen@umcg.nl.
authors.forename: N B
authors.initials: NB
authors.lastname: van Bakelen
authors.affiliation: Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, P.O. Box 30.001, 9700 RB Groningen, The Netherlands.
authors.forename: G J
authors.initials: GJ
authors.lastname: Buijs
authors.affiliation: Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, P.O. Box 30.001, 9700 RB Groningen, The Netherlands.
authors.forename: J
authors.initials: J
authors.lastname: Jansma
authors.affiliation: Department of Oral and Maxillofacial Surgery, Medical Centre Leeuwarden, P.O. Box 888, 8901 BR Leeuwarden, The Netherlands.
authors.forename: J G A M
authors.initials: JG
authors.lastname: de Visscher
authors.affiliation: Department of Oral and Maxillofacial Surgery, Rijnstate Hospital Arnhem, 6800 TA Arnhem, P.O. Box 9555, The Netherlands.
authors.forename: Th J M
authors.initials: TJ
authors.lastname: Hoppenreijs
authors.affiliation: Department of Oral and Maxillofacial Surgery, Amphia Hospital Breda, P.O. Box 90.158, 4800 RK Breda, The Netherlands.
authors.forename: J E
authors.initials: JE
authors.lastname: Bergsma
authors.affiliation: Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, P.O. Box 30.001, 9700 RB Groningen, The Netherlands; UMCG Centre for Dentistry and Oral Hygiene, Department Oral Health Care & Clinical Epidemiology, University Medical Centre Groningen, University of Groningen, P.O. Box 30.001, 9700 RB Groningen, The Netherlands.
authors.forename: B
authors.initials: B
authors.lastname: Stegenga
authors.affiliation: Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, P.O. Box 30.001, 9700 RB Groningen, The Netherlands.
authors.forename: R R M
authors.initials: RR
authors.lastname: Bos
mesh_terms: D020341:Absorbable Implants; D000293:Adolescent; D000328:Adult; D001291:Attitude of Health Personnel; D001672:Biocompatible Materials / Q000737:chemistry; D001860:Bone Plates; D001863:Bone Screws; D002983:Clinical Competence; D015331:Cohort Studies; D003657:Decision Making; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007858:Learning; D008297:Male; D008337:Mandibular Fractures / Q000601:surgery; D008440:Maxillary Fractures / Q000601:surgery; D008875:Middle Aged; D009984:Orthopedic Fixation Devices; D019340:Osteotomy, Le Fort / Q000295:instrumentation; D059229:Osteotomy, Sagittal Split Ramus / Q000295:instrumentation; D012189:Retrospective Studies; D013515:Surgery, Oral; D014025:Titanium / Q000737:chemistry; D055815:Young Adult; D015051:Zygomatic Fractures / Q000601:surgery
chemical_list: D001672:Biocompatible Materials; D014025:Titanium
keywords: Handling characteristics; Intra-operative switches; Learning curve; Osteosynthesis; Predictor variables; Surgeons' opinion