Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial.

BACKGROUND: Biodegradable fixation systems could reduce or eliminate problems associated with titanium removal of implants in a second operation. AIM: The aim of this study was to compare the long-term (i.e. >5 years postoperatively) clinical performance of a titanium and a biodegradable system in oral and maxillofacial surgery. MATERIALS AND METHODS: The present multicenter Randomized Controlled Trial (RCT) was performed in four hospitals in the Netherlands. Patients treated with a bilateral sagittal split osteotomy (BSSO) and/or a Le Fort-I osteotomy, and those treated for fractures of the mandible, maxilla, or zygoma were included from December 2006 to July 2009. The patients were randomly assigned to either a titanium (KLS Martin) or a biodegradable group (Inion CPS). RESULTS: After >5 years postoperatively, plate removal was performed in 22 of the 134 (16.4%) patients treated with titanium and in 23 of the 87 (26.4%) patients treated with the biodegradable system (P = 0.036, hazard ratio (HR) biodegradable (95% CI) = 2.0 (1.05-3.8), HR titanium = 1). Occlusion, VAS pain scores, and MFIQ showed good and (almost) pain free mandibular function in both groups. CONCLUSION: In conclusion, the performance of the Inion CPS biodegradable system was inferior compared to the KLS Martin titanium system regarding plate/screws removal in the abovementioned surgical procedures. TRIAL REGISTRATION: http://controlled-trials.com ISRCTN44212338.

Operational Definition of Active and Healthy Ageing (AHA): A Conceptual Framework.

Health is a multi-dimensional concept, capturing how people feel and function. The broad concept of Active and Healthy Ageing was proposed by the World Health Organisation (WHO) as the process of optimizing opportunities for health to enhance quality of life as people age. It applies to both individuals and population groups. A universal Active and Healthy Ageing definition is not available and it may differ depending on the purpose of the definition and/or the questions raised. While the European Innovation Partnership on Active and Healthy Ageing (EIP on AHA) has had a major impact, a definition of Active and Healthy Ageing is urgently needed. A meeting was organised in Montpellier, France, October 20-21, 2014 as the annual conference of the EIP on AHA Reference Site MACVIA-LR (Contre les Maladies Chroniques pour un Vieillissement Actif en Languedoc Roussillon) to propose an operational definition of Active and Healthy Ageing including tools that may be used for this. The current paper describes the rationale and the process by which the aims of the meeting will be reached.

Cost-Effectiveness of a Biodegradable Compared to a Titanium Fixation System in Maxillofacial Surgery: A Multicenter Randomized Controlled Trial.

BACKGROUND: Biodegradable fixation systems could reduce/delete the problems associated with titanium plate removal. This means less surgical discomfort, and a reduction in costs. AIM: The aim of the present study was to compare the cost-effectiveness between a biodegradable and a titanium system in Maxillofacial surgery. MATERIALS AND METHODS: This multicenter RCT was performed in the Netherlands from December 2006 to July 2009. Included were 230 patients who underwent a bilateral sagittal split osteotomy (BSSO), a Le Fort-I osteotomy, or a bi-maxillary osteotomy and those treated for fractures of the mandible, maxilla, or zygoma. The patients were randomly assigned to a titanium group (KLS Martin) or to a biodegradable group (Inion CPS). Costs were assessed from a societal perspective. Health outcomes in the incremental cost-effectiveness ratio (ICER) were bone healing (8 weeks) and plate removal (2 years). RESULTS: In 25 out of the 117 patients who were randomized to the biodegradable group, the maxillofacial surgeon made the decision to switch to the titanium system intra-operatively. This resulted in an Intention-To-Treat (ITT-)analysis and a Treatment-Received (TR-) analysis. Both analyses indicated that operations performed with titanium plates and screws had better health outcomes. In the TR-analysis the costs were lower in the biodegradable group, in the ITT-analysis costs were lower in the titanium group. CONCLUSION AND DISCUSSION: The difference in costs between the ITT and the TR analyses can be explained by the intra-operative switches: In the TR-analysis the switches were analysed in the titanium group. In the ITT-analysis they were analysed in the biodegradable group. Considering the cost-effectiveness the titanium system is preferable to the biodegradable system in the regular treatment spectrum of mandibular, Le Fort-I, and zygomatic fractures, and BSSO's, Le Fort-I osteotomies and bimaxillary osteotomies. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN 44212338.

Comparison of the long-term skeletal stability between a biodegradable and a titanium fixation system following BSSO advancement - a cohort study based on a multicenter randomised controlled trial.

Biodegradable fixation systems could reduce or eliminate the problems associated with removal of titanium plates. A multicenter randomised controlled trial (RCT) was performed in the Netherlands from December 2006-July 2009, and originally 230 injured and orthognathic patients were included. The patients were randomly assigned to either a titanium control group (KLS Martin) or to a biodegradable test group (Inion CPS). The aim of the present study was to compare the long-term skeletal stability of advancement bilateral sagittal split osteotomies (BSSO) of a biodegradable system and a titanium system. Only patients from the original RCT who were at least 18 years old and who had a BSSO advancement osteotomy were included. Those who had simultaneous Le Fort I osteotomy or genioplasty were excluded. Analysis of skeletal stability was made by digital tracing of lateral cephalograms. Long-term skeletal stability in BSSO advancement did not differ significantly between patients treated with biodegradable plates and screws and those treated with titanium plates and screws. Given the comparable amount of relapse, the general use of Inion CPS in the treatment of BSSO advancement should not be discouraged. On the basis of other properties a total picture of the clinical use can be obtained; the short-term stability, the intraoperative switches, the number of plates removed and cost-effectiveness. Trial registration of original RCT: http://www.controlled-trials.com; ISRCTN 44212338.

Decision-making considerations in application of biodegradable fixation systems in maxillofacial surgery--a retrospective cohort study.

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.

Comparison of biodegradable and titanium fixation systems in maxillofacial surgery: a two-year multi-center randomized controlled trial.

Biodegradable osteosynthesis could reduce/delete the problems associated with titanium plate removal. The aim of the present study was to compare the clinical performance in the first 2 post-operative years between a biodegradable and a titanium system in oral and maxillofacial surgery. The multicenter randomized controlled trial (RCT) was performed in the Netherlands from December 2006 to July 2009. Included were 230 patients who underwent a bilateral sagittal split osteotomy (BSSO) and/or a Le Fort-I osteotomy and those treated for fractures of the mandible, maxilla, or zygoma. The patients were randomly assigned to a titanium group (KLS Martin) or to a biodegradable group (Inion CPS). Plate removal was necessary in 16 of the 134 patients (11.9%) treated with titanium and in 21 of the 87 patients (24.1%) treated with the biodegradable system within the first 2 post-operative years [p = .016, HR biodegradable (95% CI) = 2.2 (1.1-4.2), HR titanium = 1]. Occlusion, VAS, and MFIQ scores showed that both groups had good mandibular function and were (almost) free of pain 1 and 2 years post-operatively (http://controlled-trials.com ISRCTN 44212338).

A randomized clinical trial of biodegradable and titanium fixation systems in maxillofacial surgery.

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).

Efficacy and safety of biodegradable osteofixation devices in oral and maxillofacial surgery: a systematic review.

The use of osteofixation devices should be evidence-based if uncomplicated bone healing is to be achieved. Numerous studies describe and claim the advantages of biodegradable over titanium devices as a bone fixation method. Here, we systematically review the available literature to determine the clinical efficacy and safety of biodegradable devices compared with titanium devices in oral and maxillofacial surgery. In addition, related general aspects of bone surgery are discussed. We conducted a highly sensitive search in the databases of MEDLINE (1966-2005), EMBASE (1989-2005), and CENTRAL (1800-2005) to identify eligible studies. Eligible studies were independently evaluated by two assessors using a quality assessment scale. The study selection procedure revealed four methodologically 'acceptable' articles. Owing to the different outcome measures used in the studies, it was impossible to perform a meta-analysis. Therefore, the major effects regarding the stability and morbidity of fracture fixation using titanium and biodegradable fixation systems were qualitatively described. Any firm conclusions regarding the fixation of traumatically fractured bone segments cannot be drawn, due to the lack of controlled clinical trials. Regarding the fixation of bone segments in orthognathic surgery, only a few controlled clinical studies are available. There does not appear to be a significant short-term difference between titanium and biodegradable fixation systems regarding stability and morbidity. However, definite conclusions, especially with respect to the long-term performance of biodegradable fixation devices used in maxillofacial surgery, cannot be drawn.