Resorbable Plating System Research Articles

Efficacy of bioresorbable plating system in the treatment of pediatric maxillary fractures: A short clinical study.

The aim of this study was to evaluate the efficacy, stability, and clinical outcomes of a bioresorbable plating system in the treatment of pediatric maxillary fractures. Twenty pediatric patients with maxillary fractures (13 males and 7 females) were included in this study. The 1.5- and 2.0-mm resorbable plates were used and secured with monocortical resorbable screws 6 mm and 7 mm in length. All patients were followed up for 6 months. Clinical parameters, such as pain, swelling, soft-tissue infection, malocclusion, nerve injury, and bite force for stability, were prospectively assessed. Fall from height (50%) was the most common cause of etiology, followed by road traffic accidents (35%). Maxillary alveolar # (40) was the most common fracture site, followed by nasal complex # (25%) and zygomatic complex # (25%). Appropriate fixation and adequate primary bone healing was achieved in 100% of the cases. Few minor complications were observed: (1) soft-tissue infection (5%) and (2) paresthesia (10%). There was a significant increase in bite force in the incisor and molar regions. Observation in clinical parameters shows that there was a significant reduction in postoperative pain and swelling at different follow-up periods. Bioresorbable plating system is used as a load-sharing plate in a semirigid fixation technique after anatomic fracture reduction. Although its high costs limit its feasibility for use low infection rates, minimized second surgery for implant removal attracts its use. 1.5- and 2-mm resorbable plating system along is a good treatment modality for moderately displaced maxillary fractures in pediatric patients. Larger sample size and longer follow-up studies are required for conclusive results.

Management of Frontal Bone Fracture in the Pediatric Population: A Literature Review

Background: The purpose of this study was to review the published literature in an effort to compare conservative and surgical interventions for pediatric frontal bone fractures and to create a treatment schematic that would result in the lowest morbidity. Methods: A literature review was performed to evaluate all publications related to frontal bone fracture treatments in the pediatric population. Patient age, fracture location, treatment modality, and complications were analyzed to elucidate whether conservative or surgical management is better for pediatric frontal bone fractures and to determine which type of management yields the lowest morbidity. Results: Sixteen articles met inclusion criteria. 88.89% of the included patients who underwent surgical repair did not experience any postoperative complications. The surgical treatments employed included craniotomy, implantation of custom macroporous hydroxyapatite prostheses, split calvarial graft, cranialization, and open reduction and internal fixation with either non-resorbable or resorbable plating systems. There were 17 cases of frontal bone fractures that were treated conservatively. Eleven of the 17 cases (61.1%) that were initially treated with conservative management resulted in complications; either a growing fracture or infection. Conclusions: No clear treatment algorithm for frontal bone fractures in each pediatric age group could be generated from the published literature. We likewise could not determine a clear distinction between the indications for conservative versus surgical management. However, we were able to conclude that primary surgical management for pediatric frontal bone fractures yields high success rates and few complications, regardless of the patient’s age.

Rigid versus Resorbable Plate Fixation in Fronto-Orbital Advancement in Unicoronal Stenosis - A Retrospective Study.

Introduction:Rigid plating fixation (RPF) and resorbable plating systems (RPS) advanced the field of reconstruction in craniomaxillofacial region. However, their performance in patients, particularly the effect on bone remodeling at site of hardware placement is not much documented. This manuscript aims to compare the performance of RPF and RPS in a cohort using a retrospective audit of case records.Methods:Archival records were searched for patients who had undergone cranial metal-RPF or RPS or combination for the correction of craniofacial deformities following inclusion-exclusion criteria. From records, data of the quality and quantity of bone formed along the site of plate fixation as compared with the adjacent site, accommodating or facilitating brain growth, and persistence of bone deformity at the site of hardware placement were collected at the end of the follow-up period. A total of 128 sites from 18 individuals (6 with exclusive metal-RPF and 12 with RPS) mean age of 7.45 ± 7.28 (Median 4; IQR of 8.88;2.6–11.5) who underwent cranial bone remodeling surgery formed the study group.Results:There was a statistically significant difference between the RPF and PRS system at the fronto-orbital suture (P = 0.002) and coronal suture (P = 0.036) with bone quality and quantity.Discussion:The RPF system was rigid but had a set of issues, while RPS has advantages and limitations. The qualitative difference in between the two systems is different. Due to inherent dissimilarity, the two systems cannot be interchanged and due diligence has to be exercised while deciding on the system. More prospective studies are needed to validate the findings.

Kondil Kırıklarında Ortotropik Mandibula Modeli ile Sonlu Eleman Analizleri Kullanılarak Titanyum ve Rezorbe Olabilen Miniplak Sistemlerinin Karşılaştırılması

ABSTRACT
 Background: Mandibular fractures comprise a large portion of facial injuries. According to comprehensive series published, 17.5 - 52% of mandibular fractures are condyle fractures. With the development of plate and screw systems, open reduction and internal rigid fixation have also become methods that are accepted. Titanium miniplate and screw systems or resorbable plate and screw systems are used for this purpose. The purpose of this study is to compare the superiorities of titanium plate and screw systems to the superiorities of resorbable plate and screw systems on an orthotropic mandibular model using the finite element analysis (FEA) method.
 Method: With finite element analysis, stress values in bone, plate, and callus and the amount of displacement in plates and fragments with Von Mises forces were examined.
 Result: It was observed that solitary resorbable plates do not generate adequate stability.
 Conclusion: It was observed that titanium plate and screw systems were mechanically superior to resorbable plate and screw systems in the open treatment of mandibular condyle fractures. However, to fully support this opinion, studies with different designs using new resorbable plates are required.

Resorbable Versus Titanium Rigid Fixation for Pediatric Mandibular Fractures: A Systematic Review, Institutional Experience and Comparative Analysis.

Pediatric mandible fractures mandate special consideration because of unerupted teeth, mixed dentition, facial growth and the inability to tolerate maxillomandibular fixation. No consensus exists as to whether resorbable or titanium plating systems are superior with regards to clinical outcomes. This study aims to systematically review and compare the outcomes of both material types in the treatment of pediatric mandible fractures. After PROSPERO registration, studies from 1990-2020 publishing on outcomes of ORIF of pediatric mandible fractures were systematically reviewed according to PRISMA guidelines. An additional retrospective review was conducted at a pediatric level 1 trauma center. 1,144 patients met inclusion criteria (30.5% resorbable vs. 69.5% titanium). Total complication rate was 13%, and 10% required a second, unplanned operation. Complication rates in the titanium and resorbable groups were not significantly different (14% vs. 10%; P = 0.07), and titanium hardware was more frequently removed on an elective basis (P < 0.001). Condylar/sub-condylar fractures were more often treated with resorbable hardware (P = 0.01); whereas angle fractures were more often treated with titanium hardware (P < 0.001). Within both cohorts, fracture type did not increase the risk of complications, and comparison between groups by anatomic level did not demonstrate any significant difference in complications. Pediatric mandible fractures requiring ORIF are rare, and hardware-specific outcomes data is scarce. This study suggests that titanium and resorbable plating systems are equally safe, but titanium hardware often requires surgical removal. Surgical approach should be tailored by fracture anatomy, age-related concerns and surgeon preference.

Comparing maximal forces in resorbable poly-L-lactic acid and titanium plates for mandibular fracture fixation

Treatment for mandibular fractures is commonly performed via open reduction fixation with mini titanium or resorbable plates and screws. The investigators hypothesized differences in maximum mechanical stress forces and deflection with each plating material; however, it was proposed that the experimental forces withstood by the resorbable system would be enough to withstand normal forces produced during mastication.The sample was composed of fresh cadaver mandibles that were harvested, fractured, and fixated with plates and screws. The predictor variable was fracture fixation and included a titanium plating or resorbable poly-L-lactide plating system. The primary outcome measure was maximum load withstood before plating failure measured in Newtons (N). Descriptive and bivariate statistics were computed, P value was set at .05.The sample was composed of six mandibles with and grouped by type of fixation modality, Titanium (T) (n = 3) and Resorbable (n = 3). There was a statistically significant correlation between the T group and increased maximum load (N) before failure as compared to the R group, (P = 0.023).The results suggest that fracture fixation with titanium plates and screws can withstand greater maximum forces before failure; however, the resorbable plating system withstood forces similar to/or greater than the maximum forces produced during normal mastication.

COMPARISON OF RESORBABLE WITH NON RESORBABLE PLATES TO TREAT PAEDIATRIC MANDIBULAR FRACTURES

Objective: The purpose of the present study was to compare the clinical efficacy and postoperative complications between resorbable and non-resorbable plates and screws in the treatment of paediatric mandibular symphysis and parasymphysis fractures. Materials and Methods: Resorbable and non resorbable plates were used in 46 paediatric patients (age ranges 6 to 12 years, mixed dentition stage) for the treatment of mandibular symphysis and parasymphysis fractures. The variables critically observed were infection, wound dehiscence, bony union and malocclusion. Results: Out of the 46 paediatric patients, 23 were in the non resorbable titanium plating group (group A) and 23 in the resorbable plating group (group B). Two patients showed minor infection at first week in group A and 1 patient in group B. Only one patient showed wound dehiscence at 4th week in group A. No malunion and malocclusion occurred during the observation period in both the groups. Conclusion: The results obtained in this study showed that morbidity in both groups was matched in term of outcomes when evaluated. The avoidance of repeat surgery for plate removal is a definite advantage of using resorbable plating system.

Polydioxanone suture fixation for the repair of pediatric maxillofacial fractures

Aim: Unique pattern of the pediatric facial skeleton and its fractures confers a special issue to take into account. Conservative management, occlusal splints and wiring techniques are popular among pediatric facial fractures. As titanium plates require plate removal after the fracture healing, resorbable plates have gained popularity. However, they are expensive and it may not be possible to obtain resorbable plates in some medical facilities. This led us to question the mechanical stability and functional outcome after fracture fixation using polydioxanone (PDS) sutures.Material and Methods: Seven children with maxillofacial fractures were included in this study. After limited sufficient dissection and periosteal striping the fracture lines were reduced and four holes were made with a drill on preoperatively planned sites where no tooth buds were projected. After that a number 2 PDS loop suture was passed through these holes in a figure of eight fashion and tied to stitches after sufficient stability and anatomic reduction.Results: No complication occurred, except for two cases that had tooth extractions.Conclusion: To sum up, PDS suture fixation in a figure of eight fashion is a feasible and cheap alternative to titanium and resorbable plate systems.

Wound Healing Complications After Cranial Vault Reconstruction for Craniosynostosis.

Craniosynostosis is a congenital cranial malformation involving premature fusion of cranial sutures. Indications for surgical repair of craniosynostosis include elevation of intracranial pressure, which can result in impaired vision and mental disability, as well as correction of abnormal skull shape. Resorbable plating systems have become the preferred technique for bony fixation in the repair of craniosynostosis. Multiple studies demonstrate the safety and low complication rate of resorbable plating systems.However, there is no consensus on which plating system is superior for patient outcomes. This study aims to investigate how the polymer composition of resorbable plating systems utilized in cranial vault reconstruction contributes to wound healing complications. A retrospective chart review was performed at the institution between January 1, 2005 and December 31, 2015. About 202 patients who underwent surgical repair of craniosynostosis were identified. The results showed that patients receiving the Biomet Lactosorb plating system were over twice as likely to have a wound complication within a year of surgery compared to other plating systems used at the institution. Wound complications continued to occur in the Biomet Lactosorb group at ≥180 days after surgery, whereas complications among the other plating systems occurred ≤80 days postoperatively. Half of all patients with wound complications had to undergo reoperation. These data demonstrate the effect of unique polymer compositions on wound healing, and will help to guide future clinical practice and industry development of resorbable plating systems.

Absorbable Fixation Devices for Pediatric Craniomaxillofacial Trauma: A Systematic Review of the Literature.

The purpose of this study was to investigate surgical outcomes with the use of resorbable plating systems for the repair of craniomaxillofacial trauma in the pediatric population. A systematic review of the literature was performed. A descriptive analysis, operative technical data, outcomes, and postoperative complications with the use of absorbable plating systems for craniomaxillofacial trauma were included. The systematic literature review identified 1264 abstracts, of which only 19 met inclusion criteria. From these 19 studies, 312 clinical cases with 443 facial fractures that were treated with absorbable fixation systems were extracted for analysis. The review identified only level III/IV (n = 17) and level V (n = 2) studies. Minor and major complications were rare, occurring in 5.45 percent (n = 17) and 3.21 percent (n = 10) of cases, respectively. The most common complications were surgical-site infections (n = 4) and plate extrusion (n = 4). This report is, to the authors' knowledge, one of the first comprehensive reports on the use of absorbable plating systems for pediatric craniomaxillofacial trauma. Their analysis suggests that the use of absorbable fixation devices for pediatric craniomaxillofacial trauma is relatively safe, with a low-risk profile. Outcome studies with longer follow-up periods specifically investigating facial growth, reoperation rates, standardized surgical outcome metrics, and cost are necessary to effectively compare these fixation devices to titanium alternatives for craniomaxillofacial trauma.

S4A-13 SESSION 4A: GENERALITIES IN CRANIOSYNOSTOSIS – PART I WOUND HEALING COMPLICATIONS AFTER SURGICAL REPAIR OF CRANIOSYNOSTOSIS: ARE ALL RESORBABLE PLATING SYSTEMS CREATED EQUAL?

Introduction: Although multiple resorbable plating systems are available for the repair of craniosynostosis, there is a no consensus on which plating system is associated with the lowest complication rates. In a previous retrospective study conducted at our institution, patients with craniosynostosis who underwent surgical repair with the Biomet Lactosorb plating system were over twice as likely to have a wound complication within a year of surgery. Our institution subsequently shifted its practice from the primary use of Biomet Lactosorb for repair of craniosynostosis to Stryker Delta and KLS Martin SonicWeld. The purpose of this study is to compare the incidence of wound complications and return to the operating room between the Stryker Delta and KLS Martin Sonic Weld resorbable plating systems. Methods: A retrospective review of institutional data was performed. Patients less than 18 years old with craniosynostosis who underwent cranial vault reconstruction or frontal orbital advancement with the Stryker Delta or KLS Martin SonicWeld resorbable plating systems between January 1, 2005 and December 31, 2018 were eligible for inclusion. The outcomes of interest were wound healing complications, defined as infection or dehiscence, and return to the operating room. Results: Overall, 242 patients underwent surgical repair of craniosynostosis at our institution between 2005 and 2018. The Stryker Delta or KLS Martin SonicWeld resorbable plating systems were used in a total of 76 patients. 41 patients had repair with Stryker Delta, while 35 patients underwent repair with KLS Martin SonicWeld. Patients who received the Stryker Delta plating system had higher rates of wound complications and return to the operating room. Conclusion: The Stryker Delta cohort had a higher wound healing complication rate (17.1%) compared to the wound complication rate of patients undergoing repair with KLS Martin SonicWeld (5.1%). Complication rates associated with resorbable plating systems should influence surgeon and institutional practice as well as industry development.

Resorbable plating system stabilizes tissue-engineered intervertebral discs implanted ex vivo in canine cervical spines.

Total disc replacement using tissue‐engineered intervertebral discs (TE‐IVDs) may offer a biological alternative to treat radiculopathy caused by disc degeneration. A composite TE‐IVD was previously developed and evaluated in rat tail and beagle cervical spine models in vivo. Although cell viability and tissue integration into host tissue were promising, significant implant displacement occurred at multiple spinal levels. The goal of the present study was to assess the effects of a resorbable plating system on the stiffness of motion segments and stability of tissue‐engineered implants subjected to axial compression. Canine motion segments from levels C2/C3 to C5/C6 were assessed as intact (CTRL), after discectomy (Dx), with an implanted TE‐IVD only (PLATE−), and with a TE‐IVD combined with an attached resorbable plate (PLATE+). Segments under PLATE+ conditions fully restored separation between endplates and showed significantly higher compressive stiffness than segments under PLATE− conditions. Plated segments partially restored more than 25% of the CTRL motion segment stiffness. Plate attachment also prevented implant extrusion from the disc space at 50% compressive strain, and this effect was more significant in segments from levels C3/C4 when compared to segments from level C5/C6. These results suggest that stabilization of motion segments via resorbable plating assists TE‐IVD retention in the disc space while allowing the opportunity for implants to fully integrate into the host tissue and achieve optimal restoration of spine biomechanics.

Use of the bioactive resorbable plate system for zygoma and zygomatic arch replacement and fixation with modified Crockett's method for maxillectomy: A technical note.

As a surgical approach targeting the pterygopalatine fossa following maxillary cancer due to tumor invasion, Crockett's method is conventional and useful. However, if the tumor is confined to the area between the maxilla and pterygopalatine fossa, it is not necessary to include the zygomatico-orbital in the access osteotomy, and the orbital floor may be preserved. Depending on the range of tumor invasion, the current study reports a more minimally invasive, modified Crockett's surgery that may be considered, which includes resection with modified osteotomy lines and repositioning with fixation of the zygoma and zygomatic arch following maxillary cancer ablation. In addition, the majority of patients with advanced maxillary cancer may require postoperative radiotherapy or chemoradiotherapy following maxillectomy according to several guidelines. Therefore, using a low-profile bioactive resorbable plate system as a method of repositioning and fixing the resected and preserved zygoma and zygomatic arch may be more effective in this modified Crockett's method for maxillectomy.

Long-Term Outcomes of Pediatric Cranial Reconstruction Using Resorbable Plating Systems for the Treatment of Craniosynostosis.

Resorbable plating in cranial reconstruction for craniosynostosis has fewer reported complications than rigid hardware. Few long-term outcome studies exist for pediatric patients treated with this technology for cranial vault reconstruction. A retrospective review was performed on pediatric patients undergoing cranial vault reconstruction for craniosynostosis by 3 surgeons over a 15-year period. MacroPore (Cytori Therapeutics, San Diego, CA) or Lactosorb (Walter Lorenz Surgical Inc, Jacksonville, FL), composed of polyglycolic and polylactic acids, was used for resorbable plate fixation. A total of 203 patients underwent resorbable plate fixation with a mean age of 15.8 months at surgery. Mean length of follow-up was 6.4 years. Lactosorb plating system was used in the majority of patients (74%) compared with MacroPore plating system (26%). Overall, unplanned reoperations were required in 5.4% of patients. Palpable hardware was noticed in 10.3% of patients. Only 3 patients (1.5%) developed exposure of the resorbable hardware requiring removal, all MacroPore plates. Four patients (2%) developed surgical site infection and 3 patients (1.5%) developed a seroma. There were 15.8% requiring later surgical revision with cranial vault expansion or cranioplasty with grafts for residual cranial defects. The majority of revisional reoperations (81%) occurred in the first half of the study before the addition of Allogenix. Resorbable plating systems, specifically Lactosorb, for cranial reconstruction are a safe, reproducible, inexpensive modality with very low complication rates. They have 3-dimensional stability, rigid fixation without causing growth restriction, and lower likelihood of need for removal.

Fractures of the zygomaticomaxillary complex and their treatment: A case report

Fractures of the zygomaticomaxillary complex are the second most common of all facial fractures. Several fixation methods have been used over the years, including wire osteosynthesis, lag screw fixation, trans-facial Kirschner wire fixation, titanium plate and screw fixation, and more recently, resorbable plating system. Internal fixation with titanium plates and screw provides the most rigid fixation and thus greater immobility of the fracture segments. The degree of immobilization created with titanium plates and screws also allows fixation at fewer anatomic points.

Management of pediatric mandibular fractures using bioresorbable plating system – Efficacy, stability, and clinical outcomes: Our experiences and literature review

AimsThe purpose of this study was to determine the efficacy and stability of the biodegradable fixation system for treatment of mandible fractures in pediatric patients by measuring the bite force. MethodsSixty pediatric patients with mandibular fractures (36 males, 24 females) were included in this study. The 2.5-mm resorbable plates were adapted along Champy's line of ideal osteosynthesis and secured with four 2.5mm diameter monocortical resorbable screws, 8mm in length. All patients were followed for 10 months. Clinical parameters, such as soft tissue infection, nonunion, malunion, implant exposure, malocclusion, nerve injury, and bite force for stability, were prospectively assessed. ResultsAdequate fixation and primary bone healing was achieved in 100% of the cases. Six minor complications (10%) were observed: 2 soft tissue infections (3%), 1 plate dehiscence (2%), 1 malocclusion (2%), and 2 paresthesia (3%). Conclusion2.5-mm resorbable plating system along Champy's line of ideal osteosynthesis is a good treatment modality for mandible fractures in pediatric patients.

Use of self-tapping metal screws for temporary fixation of a resorbable plate system in maxillofacial surgery.

Resorbable plate systems have been used in maxillofacial surgery to obviate the need for plate removal. However, resorbable plates and screws are very costly, and refixation with additional screws may be necessary when reduction or repositioning of the bone segment is inaccurate. Here we report the use of self-tapping metal screws for temporary fixation of a resorbable plating system in maxillofacial surgery to avoid the use of additional screws following inaccurate fixation or the reuse of resorbable screws, which may result in loosening.

COMPARATIVE EVALUATION OF THE MECHANICAL PROPERTIES OF RESORBABLE AND TITANIUM MINIPLATES USED FOR FIXATION OF MANDIBULAR CONDYLE FRACTURES

In this paper, comparative evaluation of the mechanical properties of resorbable and titanium miniplates, which are used for the fixation of the mandibular condyle fractures, was carried out using finite element analysis (FEA). To do so, first two-dimensional (2D) computed tomography (CT) images of mandibles recorded from 10 adult patients were converted into three-dimensional (3D) solid body models. Then these models were transferred to the finite element software. In the finite element stage of the study, a condyle fracture was created onto the mandible and double-titanium and double-resorbable miniplates were separately fixed to the mandible surface such that the fractured sites to be firmly attached. Stress distribution over the plates and interfragmentary displacements between adjacent surfaces, which stem from the clenching force applying to the mandible, were calculated using FEA. It was observed from the results that maximum tensile stresses occurred in the titanium miniplates were significantly higher than those obtained from resorbable miniplates (p &lt; 0.01). Higher maximum displacements between fractured surfaces were observed in the case of resorbable plate systems (p &lt; 0.01). Maximum stress and displacement values obtained from both titanium and resorbable plate systems were under clinically acceptable limits. According to results, resorbable plates showed a similar reliability with titanium miniplates in terms of withstanding various stress and strain deformations.

Frontal cranial modeling using endocranial resorbable plate fixation in 27 consecutive plagiocephaly and trigonocephaly patients.

Premature ossification of coronal and metopic sutures is treated by fronto-orbital remodeling. Such operations require stable fixation of the reshaped cranial bones. Currently, biodegradable plating systems are used to provide sufficient stability over the time that takes for the osteotomies to ossify. Plates that are placed traditionally on the outer surface of the cranium are often palpable and even visible through the thin overlying skin, compromising the cosmetic results of these operations. Improved aesthetics could be achieved by placing the plates endocranially. This study aimed to evaluate endocranial resorbable plate fixation and its clinical and radiographic results in frontal remodeling cranioplasty for plagiocephaly and trigonocephaly patients with follow-up sufficiently long for the plates to have been completely resorbed. A poly(lactide-co-glycolide) (PLGA) resorbable plating system was used on the inner aspect of frontal bone in 27 patients treated for coronal and metopic craniosynostoses. The outcome was evaluated at follow-up visits. The mean follow-up was 79.2months. Three patients had complications that required reoperations. None of these complications were related to the endocranial location of the plates. There were no problems with ossification of the osteotomy sites. All but one patient's outcome was judged as good or excellent. Placement of resorbable fixation on the endocranial surface of the calvarial bones is safe, stable, and results in satisfactory aesthetics without interfering with the ossification of the cranial bones.

Use of templates and self-tapping metal screws for temporary fixation of a resorbable plate system.

Resorbable plate systems combine the benefits of rigid internal fixation with the convenience of biodegradation; thus, precluding the need for removal and reducing their interference with craniofacial growth. However, in surgeries involving maxillofacial bone, when reduction or repositioning of the bone segment is inaccurate, refixation and rebending of the plate may be necessary. Here, we report using a temporary plate with self-tapping metal screws to avoid repeated rebending of the resorbable plate and using additional screws following inaccurate fixation in maxillofacial surgeries.