Bioresorbable Fixation System Research Articles

Efficacy of bioresorbable plates in the osteosynthesis of linear mandibular fractures.

Background and Objectives:There are limited evidences available about the performance of biodegradable system in the treatment of linear mandibular fractures without the aid of postoperative maxillomandibular fixation (MMF). Hence, the present study was planned to evaluate the treatment outcomes in mandibular fractures, using 2.5 mm bioresorbable plates and screws without postoperative MMF.Methodology:This cohort study compares both prospective and retrospective data. The prospective study treated 20 adult patients with linear mandibular fracture using bioresorbable plates and screws, without using postoperative MMF (Group 1). Retrospective data were collected from a previous published study in which patients were treated with bioresorbable plates and screws with 2 weeks postoperative MMF (Group 2) and those treated with metal plates and screws without postoperative MMF (Group 3). Group 1 patients were followed up at 2 and 4 months to evaluate the functional outcomes in terms of fracture mobility, malocclusion, pain, and soft-tissue deformity and compared with its preoperative findings. Further, the treatment outcomes of Group 1, Group 2, and Group 3 were compared among themselves at 2-month follow-up.Results:Group 1 patients showed a significant improvement in the treatment outcomes at 2 and 4-month follow-up. In addition, when 2 months postoperative outcomes were compared among the three groups, no statistically significant difference was observed in the treatment outcomes.Conclusion:Endpoint osteosynthesis can be achieved with the bioresorbable fixation system when used in the treatment of un-displaced linear mandibular fractures, without postoperative MMF. A minor modification of using a lower size osteotomy drill can prevent screw loosening.

Resorbable versus titanium plates for orthognathic surgery.

Recognition of some of the limitations of titanium plates and screws used for the fixation of bones has led to the development of plates manufactured from bioresorbable materials. Whilst resorbable plates appear to offer clinical advantages over metal plates in orthognathic surgery, concerns remain about the stability of fixation and the length of time required for their degradation and the possibility of foreign body reactions. This review compares the use of titanium versus bioresorbable plates in orthognathic surgery and is an update of the Cochrane Review first published in 2007. To compare the effects of bioresorbable fixation systems with titanium systems used during orthognathic surgery. Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 20 January 2017); the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 11) in the Cochrane Library (searched 20 January 2017); MEDLINE Ovid (1946 to 20 January 2017); and Embase Ovid (1980 to 20 January 2017). We searched the US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (clinicaltrials.gov; searched 20 January 2017), and the World Health Organization International Clinical Trials Registry Platform (searched 20 January 2017) for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases. Randomised controlled trials comparing bioresorbable versus titanium fixation systems used for orthognathic surgery in adults. Two review authors independently screened the results of the electronic searches, extracted data and assessed the risk of bias of the included studies. We resolved disagreement by discussion. Clinical heterogeneity between the included trials precluded pooling of data, and only a descriptive summary is presented. This review included two trials, involving 103 participants, one comparing titanium with resorbable plates and screws and the other titanium with resorbable screws. Both studies were at high risk of bias and provided very limited data for the primary outcomes of this review. All participants in one trial suffered mild to moderate postoperative discomfort with no statistically significant difference between the two plating groups at different follow-up times. Mean scores of patient satisfaction were 7.43 to 8.63 (range 0 to 10) with no statistically significant difference between the two groups throughout follow-up. Adverse effects reported in one study were two plate exposures in each group occurring between the third and ninth months. Plate exposures occurred mainly in the posterior maxillary region, except for one titanium plate exposure in the mandibular premolar region. Known causes of infection were associated with loosened screws and wound dehiscence with no statistically significant difference in the infection rate between titanium (3/196), and resorbable (3/165) plates. We do not have sufficient evidence to determine if titanium plates or resorbable plates are superior for fixation of bones after orthognathic surgery. This review provides insufficient evidence to show any difference in postoperative pain and discomfort, level of patient satisfaction, plate exposure or infection for plate and screw fixation using either titanium or resorbable materials.

Skeletal stability of bioresorbable fixation in orthognathic surgery: A systemic review

BackgroundOver the past 20 years, there has been an increase in the use of bioresorbable fixation system in orthognathic surgery, but concerns remain about the stability of fixation. This review is to seek evidence for the effectiveness of bioresorbable fixation systems compared to titanium systems used for orthognathic surgery. MethodsA systematic review of the scientific literature listed on PubMed, Embase, Cochrane Central Register of Systemic Reviews and Cochrane Central Register of Controlled Trials was performed, up to December 2012. ResultsTwenty articles were selected based on inclusion and exclusion criteria: five RCTs and fifteen prospective. We compared these studies, published between 1997 and 2012 and involving 1092 participants examining skeletal stability of bioresorbable fixation in orthognathic surgery. ConclusionThis review found that the published data have shown that bioresorbable fixation systems produce reliable skeletal stability.

The Fixation Effect of a Silk Fibroin–Bacterial Cellulose Composite Plate in Segmental Defects of the Zygomatic Arch<subtitle>An Experimental Study</subtitle><alt-title>Silk Fibroin–Bacterial Cellulose Composite Plate</alt-title>

Bioresorbable fixation systems have been popular for the treatment of facial fractures. However, their mechanical properties are uncertain and complications have been reported. To overcome these problems, we developed a bioresorbable fixation plate using a composite of silk fibroin and bacterial cellulose (SF-BC) with biodegradability and increased biocompatibility. To investigate the regenerative effect of the bioresorbable SF-BC fixation plate on zygomatic arch defects in rats. In vivo animal study. The SF-BC composite plate had a tensile strength similar to that of a polylactic acid plate and a tight, pore-free microstructure. Bilateral segmental bone defects (2 mm in length) were created in the zygomatic arches of adult rats. One side was fixed with the SF-BC composite plate, and the other side was left without fixation. Academic research laboratory. Fifteen adult Sprague-Dawley rats. Fixation of the zygomatic arch defect with the SF-BC composite plate. Micro-computed tomography and histological evaluation of bone samples. Gross inspection revealed no specific complication. At 1, 2, 4, and 8 postoperative weeks, the zygomatic arches were explored by micro-computed tomography and histological examination. Control sides did not heal completely and showed bony degeneration and necrosis during the 8-week follow-up. However, we observed new bone formation in sides treated with the SF-BC composite plate, and bony defects were completely healed within 8 weeks. The SF-BC composite plate is a potential candidate for a new bioresorbable fixation system. Our composite material could considerably shorten bone regeneration time. Additional study of the control of biodegradability and mechanical properties of SF-BC composite plates and a comparative study with the resorbable plates currently in use should be undertaken.

Bone resorption after bioresorbable fixation of a fractured paediatric mandible – a case report

AbstractThe use of bioresorbable fixation systems has been gaining fast momentum in contemporary maxillofacial traumatology. While indications continue to expand with improvements in strength and profiles of these implants, undesirable events, including localised sterile abscesses and osteolytic changes, have been reported during degradation of these products. We report a case of a fracture of paediatric mandiblular angle managed with bioresorbable fixation that showed significant bone resorption adjacent to the fixation site 18 months post‐operatively.

Resorbable versus titanium plates for facial fractures

Rigid internal fixation of the jaw bones is a routine procedure for the management of facial fractures. Titanium plates and screws are routinely used for this purpose. The limitations of this system has led to the development of plates manufactured from bioresorbable materials which, in some cases, omits the necessity for the second surgery. However, concerns remain about the stability of fixation and the length of time required for their degradation and the possibility of foreign body reactions. To compare the effectiveness of bioresorbable fixation systems with titanium systems for the management of facial fractures. We searched the following databases: The Cochrane Oral Health Group's Trials Register (to 20th August 2008), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, Issue 3), MEDLINE (1950 to 20th August 2008), EMBASE (from 1980 to 20th August 2008), http://www.clinicaltrials.gov/ and http://www.controlled-trials.com (to 20th August 2008). Randomised controlled trials comparing resorbable versus titanium fixation systems used for facial fractures. Retrieved studies were independently screened by two review authors. Results were to be expressed as random-effects models using mean differences for continuous outcomes and risk ratios for dichotomous outcomes with 95% confidence intervals. Heterogeneity was to be investigated including both clinical and methodological factors. The search strategy retrieved 53 potentially eligible studies. None of the retrieved studies met our inclusion criteria and all were excluded from this review. One study is awaiting classification as we failed to obtain the full text copy. Three ongoing trials were retrieved, two of which were stopped before recruiting the planned number of participants. In one study, the excess complications in the resorbable arm was declared as the reason for stopping the trial. This review illustrates that there are no published randomised controlled clinical trials relevant to this review question. There is currently insufficient evidence for the effectiveness of resorbable fixation systems compared with conventional titanium systems for facial fractures. The findings of this review, based on the results of the aborted trials, do not suggest that resorbable plates are as effective as titanium plates. In future, the results of ongoing clinical trials may provide high level reliable evidence for assisting clinicians and patients for decision making. Trialists should design their studies accurately and comprehensively to meet the aims and objectives defined for the study.

Three year experience of a Bioresorbable fixation system in orthognathic surgery

Introduction: Recognition of some of the limitations of titanium plates and screws used for skeletal fixation has led to the development of plates and screws manufactured from bioresorbable materials. Whilst resorbable plates appear to offer some clinical advantage over titanium plates in orthognathic surgery, there are concerns about the rate of postoperative infection, stability of fixation, length of time required for degradation, and foreign body reactions. Such complications may lead to further surgery, often under general anaesthesia.

Ultrasonic Welding in a Bioresorbable Implant System: Uses in Pediatric Neurosurgery

Introduction The clinical experience with a bioresorbable fixation system that employs ultrasound as a method of fixation in pediatric neurosurgery has not been previously described. We report our experience with the use of ultrasonic fixation of PDLLA implants in our operative practice. The complications, limitations, and advantages of using this commercially available system (SonicWeld Rx, KLS Martin L.P.) will also be described. Results Over a period of 18 months, 23 consecutive patients had placements of these implants for bony fixation during craniotomies or craniofacial reconstructions. Patient age ranged from 2 months to 18 years. Types of pathologies were as follows: craniosynostosis (10); tumor (6); trauma (4); and congenital cysts (3). The only morbidity was seen in a child with Crouzon syndrome, who had a wound infection following Serratia sepsis from a central venous line infection. There were no cases of premature plate reabsorption, bony instability or settling, or skin breakdown. Ease of im...

A double blind study comparing titanium and bioresorbable fixation for mandibular fracture in a UK population

Mandibular fracture is a common injury in the UK. Current best practice is to use a titanium based internal fixation for the treatment of simple fractures. Our aim was to see how a bioresorbable fixation system would compare with a titanium based system.

Preliminary assessment of skeletal stability after sagittal split mandibular advancement using a bioresorbable fixation system

We studied skeletal stability during the first year after mandibular advancement and fixation with bioresorbable self-reinforced poly- l-lactide (SR-PLLA) screws in 11 patients by cephalometric measurements. We compared these with a cohort of 11 patients, in whom titanium screws were used for fixation. We found no significant difference between the two groups in the median preoperative cephalometric values and the median changes after operation. There was also no significant difference between the two groups regarding the median extent of relapse 1-year after operation. We conclude that bioresorbable SR-PLLA screws are comparable to metallic screws for fixation of bone after sagittal split mandibular advancement.

The efficacy of bioresorbable fixation in the repair of mandibular fractures: An animal study

Purpose: The efficacy of bioresorbable fixation has recently been described in the treatment of cranial vault deformities and in midfacial trauma. However, little to no data exist regarding its use in load-bearing areas. The purpose of this study is to analyze and compare the treatment of mandibular fractures by using a bioresorbable fixation system with a conventional titanium system in a canine model. Materials and Methods: Four adult beagles constituted the experimental group (A), and 2 beagles constituted the control group (B). Both groups underwent extraoral iatrogenic left mandibular angle osteotomies/fractures and open reduction and internal fixation by use of a bioresorbable fixation system (A) or a titanium fixation system (B). All operated animals were allowed to function immediately. Lateral skull radiographs were obtained preoperatively, immediately postoperatively after reduction, and at 3- and 6-month intervals. Preoperative and 6-month follow-up bite registrations were taken. At the 3-month interval, 1 animal from the experimental group was killed, and at 6 months the remaining animals were killed for morphologic, radiographic, and histologic analysis of the fractured interface and screw sites. Results: Morphologically, in the bioresorbable group, there was no clinical evidence of 1) intraoral/extraoral incisional dehiscence of wound infection; 2) deviation of the occlusion from maximum intercuspation; 3) intraoral/extraoral palpability of the device; 4) mobility of the fractured segments on manual manipulation; or 5) malunion as visualized at the time of sacrifice. All bioresorbable plates were clinically absent after 6 months and associated with adequate fixation and healing. Adequate restoration of function was achieved in both groups, with all of the animals showing weight gain. Radiographically, good alignment of the inferior border was seen, and histologically bony union was apparent in all specimens. Conclusions: This bioresorbable fixation system is effective in the treatment of mandibular angle fractures in a dog model, despite being placed in a load-bearing region. © 2000 American Association of Oral and Maxillofacial Surgeons

Early experience with biodegradable fixation for congenital pediatric craniofacial surgery.

We describe early experience using a polymeric bioresorbable bone fixation system in a consecutive series of eight pediatric patients for the correction of craniofacial malformations. Indications for surgical treatment included craniosynostosis (7) and encephalocele (1). All patients underwent bifrontal craniotomies with cranial vault or orbital reconstruction or both. Segments were then stabilized using bioresorbable fixation systems. Patients were evaluated pre- and postoperatively clinically and with radiographs and photographs. Mean follow-up was 4.5 months, with a minimum follow-up of 3 months. In seven of eight patients, there was no incidence of infection, extrusion, exposure, erythema, instability of the advanced segments, relapse, hematoma, seroma formation, or adverse inflammatory reaction. One patient experienced difficulty with respect to system imperfections (i.e., drill holes after tapping were too large for screws). This study demonstrated the efficacy of bioresorbable plates and screws for the growing pediatric craniofacial patient; excellent short-term results were achieved. Prospective studies and longer longitudinal follow-up of larger numbers of patients are desirable to confirm these findings.