Bioresorbable Fixation Research Articles

Current Concepts in the Treatment of Lateral Condyle Fractures in Children.

Lateral condyle fractures of the humerus are the second most common fracture about the elbow in children. The injury typically occurs as a result of a varus- or valgus-applied force to the forearm with the elbow in extension. Plain radiographs are sufficient in making the diagnosis; however, an elbow arthrogram permits optimal visualization of the articular surface in minimally displaced fractures. Traditionally, nonsurgical management is indicated for fractures with ≤2 mm of displacement and a congruent articular surface. Closed reduction and percutaneous pinning is performed for fractures with >2 mm of displacement with an intact cartilaginous hinge at the articular surface. Open reduction and internal fixation is often necessary for fractures with ≥4 mm of displacement or if there is articular incongruity. Complications include malunion, delayed presentation, fishtail deformity, lateral spurring, and growth arrest. Evolving management concepts include relative indications for surgical management, the optimal pin configuration, and the use of cannulated screw and bioresorbable fixation.

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.

The Advantages of Bioresorbable INION� Implants in Traumatology Design, polymer composition and preliminary results

Some disadvantages of traditional metallic implants used in orthopedics and traumatology prompted the development of bioresorbable polymer devices.The aim of this experimental study is to emphasize the characteristics of INION� resorbable implants (regarding design and polymers compositions), as well as to evaluate the results when using these innovative implants in two trauma cases. The polymers used in manufacturing INION� devices (Trimethylene Carbonate/TMC; L-Polylactic acid/LPLA; D,L Polylactic acid/DLPLA; Polyglycolic acid/PGA) degrade in alpha-hydroxy acids, gradually losing their hardness in 18-36 weeks with a complete bioresorption of 2-4 years. The clinical cases demonstrated the advantages of INION� plates (adapted shape, low profile, polyaxial screws, acceptable strength) or pins (allowing the aligmment and fixation of fracture, no migration). Among our patients, we found excellent results concerning the maintaining of primary reduced fracture, active range of motion, minimal pain with improving everyday comfort, no tissue or implant complications. Bioresorbable fracture fixation INION� devices are a viable alternative to traditional metallic implants, offering same significant advantages over them: the avoidance of long-term interference with gliding structures, keeping their strength long enough to support bone healing, no need to remove the implants, less pain, radiolucency, elimination of stress shielding and a lower risk of complications.

High performance resorbable composites for load-bearing bone fixation devices.

Bone fractures are some of the most common injuries annually, and many require a fixation device to help properly heal. The present study focuses on developing a bioresorbable composite that has high strength and stiffness for bone fixation applications. To achieve this, a design of experiments was performed, testing the effect of long fiber reinforcement type, matrix type, matrix amount, and particle reinforcement amount on the flexural properties of the composite. Based on these results, the ideal resorbable long fiber reinforcement, particle reinforcement, and matrix material are degummed silk fibroin, hydroxyapatite, and polylactic acid, respectively. Through further optimizations of the particle reinforcement phase a flexural modulus and strength of 13.7 GPa and 437 MPa, respectively, was achieved. Both values are among the highest found in literature, with the strength far exceeding the requirement for a fixation device and the highest for such a bioresorbable composite material, showing great promise for use as a bioresorbable fixation device.

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.

Cytotoxicity Evaluation of Bioresorbable Fixation Screws on Human Gingival Fibroblasts and Mouse Osteoblasts by Real-Time Cell Analysis

To evaluate the effects of bioresorbable fixation screws (BFSs) on human gingival fibroblast (HGF) and mouse osteoblast (MC3T3-E1) cell viability. The KLS Martin SonicPins Rx, Synthes RapidSorb Cortex Screws, and Inion CPS Bioabsorbable Fixation System each were incubated in Dulbecco's Modified Eagle Medium for 72 hours according to ISO 10993-5 standards. A real-time cell analyzer was used to evaluate cell survival. After seeding 200-μL cell suspensions in the wells of an E-plate View 96, HGF and MC3T3-E1 cells were treated with the bioactive components released by the bioresorbable materials and monitored every 15 minutes for 96 hours. Statistical significance was determined using 1-way analysis of variance and Tukey-Kramer tests. There were significant differences in the HGF responses to the untreated control conditions and the Synthes (P < .01), Inion (P < .05), and KLS Martin (P < .05) treatments over 48 hours. The Synthes (P < .01) and Inion (P < .01) treatments produced lower HGF cell index values than the untreated control at 72 hours, whereas the KLS Martin treatment did not. When left to elute for 96 hours, there were no significant differences in values among the control and study groups for HGFs (P > .05). All tested BFSs decreased cell survival rates of M3T3C1 cells for 48 hours (P < .01), 72 hours (P < .001), and 96 hours (P < .001). Differences in the sensitivities of the 2 tested cell lines to the different BFSs might be the result of the different materials used to manufacture the screws. These results provide fundamental knowledge and new insights for the future design and development of new biocompatible BFSs for oral and maxillofacial surgery.

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.

Reinforced bioresorbable implants for craniomaxillofacial osteosynthesis in pigs

Our aim was to design a new bioresorbable fixation device for craniomaxillofacial surgery based on reinforcement of fibres between 2 different polymers. The final device, the 2.8mm polyglycolide fibre-reinforced-poly-l-lactide screw (PGA FR-PLLA; PLLA/PGA: 70%:30%), was evaluated for its mechanical properties and compared with a commercial resorbable device that was not reinforced with fibre. To model clinical conditions, a unilateral sagittal split ramus osteotomy fixation model in pigs was then used to compare the clinical effectiveness of the resorbable screw with that of a titanium screw in vivo, followed by 3-dimensional reconstructive imaging and histological analysis. Finally, an ex vivo biomechanical test was completed to investigate the immediate fixation stability of the newly designed screws. The PGA FR-PLLA screw resulted in clinical healing that was comparable to that of the titanium screw and was mechanically superior to the commercial device, indicating that the newly-developed screws have a potential clinical application.

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

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.

Retrospective Review of Resorbable Plate Fixation in Pediatric Craniofacial Surgery

Objective: To determine the long-term efficacy of resorbable plate fixation in pediatric patients undergoing craniofacial surgery for congenital anomalies, traumatic deformities, or skull base tumors. Design: Retrospective case review. Materials and Methods: Medical records of 57 consecutive cases using resorbable plates and screws for craniofacial fixation in patients younger than 18 years were analyzed. Main Outcome Measures: The status of bone healing postoperatively (anatomical union, malunion, delayed union, or nonunion) and any complications or adverse effects (hardware visibility or palpability, plate extrusion, or infection) were noted. Results: In midfacial and upper face procedures (54 patients) anatomical union and uncomplicated bone healing occurred in 52 (96%) of the patients. In this same group, complications (plate extrusion) occurred in 2 patients (3.7%) and were resolved using conservative treatment without untoward sequelae. These outcomes are comparable to results using metal osteosynthesis in similar situations. Costs of resorbable hardware are similar to existing metal fixation systems. Conclusions: Our data support the use of bioresorbable plate fixation in pediatric craniofacial surgery as a means of avoiding the potential and well-documented problems with rigid metal fixation. Indications include fractures and segmental repositioning in low-stress nonload-bearing areas of the middle and upper craniofacial skeleton. Although there is an initial learning curve in using this technology, we believe the benefits are well worth the effort and represent a major advance in pediatric craniofacial surgery.

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.

Equivalence Randomized Controlled Trial of Bioresorbable Versus Titanium Miniplates in Treatment of Mandibular Fracture: A Pilot Study

The present study was undertaken to test bioresorbable fixation versus titanium for equivalence in terms of clinical union and complications using the American Association of Oral and Maxillofacial Surgeons parameters of care. The study design was a randomized, controlled, equivalence trial. A total of 40 patients were enrolled and allocated to the titanium group and bioresorbable group using a computerized randomization table. All were plated using standard plating principles. In the bioresorbable group, 2 weeks of maxillomandibular fixation was also used. Evaluation of the study endpoint was done at 8 weeks postoperatively. For statistical analysis, the upper limit of the 95% confidence interval was calculated for failure to achieve the primary outcome variable and compared with the maximal clinically acceptable difference between the standard and test modalities in the failure to achieve clinical union (delta). Delta was predetermined as 2%. The other complications were tested for significance using Fisher's exact test. Of the 40 patients, 21 were in the titanium group and 19 were in the bioresorbable group, with 20 men and 1 woman in the titanium group and 18 men and 1 woman in the bioresorbable group. The mean age was 28.7 years in the titanium group and 26.6 years in the bioresorbable group. In the titanium group, the complications noted were nonunion in 0%, malocclusion in 7.7%, continued postoperative swelling in 0%, chronic pain in 2%, infection in 5.2%, an inability to chew hard food after 8 weeks in 7.7%, the need for alternative treatment in 0%, and the need for reoperation in 31%. In the bioresorbable group, the complications were nonunion in 4.17%, malocclusion in 11.1%, swelling in 8.3%, chronic pain in 37.5%, infection in 0%, an inability to chew hard food in 11.1%, the need for alternative treatment in 11.1%, and need for reoperation for plate removal in 0%. The small sample size did not allow any meaningful conclusion to be drawn from the present study in terms of the primary question of achieving union. Both groups matched in outcomes when evaluated only on a clinical basis. The avoidance of repeat surgery for plate removal is a definite advantage of using resorbable plates. However, the results are inconclusive in favor of any particular plating system.

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.

WITHDRAWN: Bioresorbable fixation devices for musculoskeletal injuries in adults.

Bioresorbable implants for musculoskeletal injuries involving bone and ligaments in adults might have significant advantages compared to the conventionally used non-resorbable metal implants because they lead to a gradual transfer of the mechanical load from the implant to the healing bone and do not require a secondary removal operation. Tissue reactions may present a problem and bioresorbable screws are mechanically not as strong as their metal counterparts. To compare bioresorbable implants to non-resorbable implants with respect to functional outcome, wound infections, other complications and reoperation rate,in the fixation of bone fractures or re-attachment of soft tissue to bone. We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (March 2004), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2004), MEDLINE (1966 to February 2004), EMBASE (1988 to February 2004), BL Inside (to February 2004), SIGLE (to February 2004), the metaRegister of Controlled Trials at http//:controlled-trials.com/, and reference lists of articles. Randomised controlled trials (RCTs) and quasi-randomised trials, comparing bioresorbable osteosynthesis with metal osteosynthesis (including titanium and stainless steel implants) were included. Review authors independently assessed trial quality and extracted data. Data were pooled where relevant and possible. Sub-analyses for specific type of fractures and for specific type of tissue reactions were performed. Requests for more information were sent to trialists. No significant difference between the bioresorbable and other implants could be demonstrated with respect to functional outcome, infections and other complications. Reoperation rates were lower in some of the groups of people treated with bioresorbable implants. In a selected group of compliant patients with simple fractures, the use of bioresorbable fixation devices might be advantageous.

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...

Stability and morbidity of Le Fort I osteotomy with bioresorbable fixation: a randomized controlled trial

A randomized controlled clinical trial was conducted to compare the use of bioresorbable and titanium mini-plates and screws in Le Fort I maxillary osteotomies for evaluation of clinical morbidity and stability. Forty patients requiring Le Fort I osteotomies were randomly assigned to two groups. One group underwent bioresorbable mini-plate fixation and the other titanium mini-plate fixation. Stability of the maxilla was determined by serial cephalometric analysis at 2 and 6 weeks and at 3, 6 and 12 months postoperatively. Subjective and objective assessment of clinical morbidity was made prospectively. There were no differences in complications between the two fixation materials. Maxillae with bioresorbable fixation were significantly more mobile at the second postoperative week. Bioresorbable plates were initially more easily palpable, but their palpability decreased with time. Titanium plates became significantly more palpable at the 1-year follow-up. There was no difference in neurosensory disturbance between groups. Patients with bioresorbable plate fixation showed significantly more upward displacement in anterior maxilla following impaction and posterior maxilla following downgrafting from the 2nd to 6th postoperative week. The horizontal and angular relapses in the two groups were comparable. Le Fort I osteotomy with bioresorbable fixation results in no greater morbidity than with titanium fixation up to 1 postoperative year.

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.

O.424 Stability and morbidities of Le Fort I osteotomies with bioresorbable fixation – A randomized controlled trial

O.424 Stability and morbidities of Le Fort I osteotomies with bioresorbable fixation – A randomized controlled trial

Bioresorbable fixation devices function similarly to titanium in fixation for orthognathic surgery

Bioresorbable fixation devices function similarly to titanium in fixation for orthognathic surgery