Biodegradable Osteosynthesis System Research Articles

Comparison of Skeletal Stability after Le Fort I Osteotomy With Bone Fixation Using Biodegradable and Titanium Systems: A Retrospective Study.

The titanium osteosynthesis system used for fixing bone segments after maxillary osteotomy provides reliable outcomes owing to its biocompatibility and adequate strength. In addition, several studies have evaluated the skeletal stability after maxillary osteotomy with fixation using a biodegradable system. However, the indications for applying a biodegradable system after maxillary osteotomy remain controversial. Therefore, this study aimed to compare the long-term skeletal stability of bone segments after maxillary osteotomy with bone fixation using biodegradable and titanium osteosynthesis systems and to assess the usefulness of a biodegradable osteosynthesis system. Patients who underwent Le Fort I osteotomy of the maxilla to correct jaw deformities between April 2008 and March 2021 were included in this study. A total of 45 patients were included, with 28 in the biodegradable osteosynthesis system group and 17 in the titanium group. Cephalometric and computed tomography analyses were performed to evaluate the skeletal stability of the bone segments after maxillary osteotomy with bone fixation using biodegradable or titanium osteosynthesis systems. The maxillary segment was repositioned anteriorly with a clockwise rotation. Skeletal stability was similar between the biodegradable and titanium osteosynthesis systems. Segmental changes occurred mainly in the first 6 months after surgery, and the segment was completely stable between 6 and 12 months after surgery. This study revealed no significant differences in skeletal stability after maxillary osteotomy between the biodegradable and titanium osteosynthesis systems. However, the findings in this study should be interpreted with caution owing to the small sample size and small amount of maxillary-segment movement.

Titanium or Biodegradable Osteosynthesis in Maxillofacial Surgery? In Vitro and In Vivo Performances.

Osteosynthesis systems are used to fixate bone segments in maxillofacial surgery. Titanium osteosynthesis systems are currently the gold standard. However, the disadvantages result in symptomatic removal in up to 40% of cases. Biodegradable osteosynthesis systems, composed of degradable polymers, could reduce the need for removal of osteosynthesis systems while avoiding the aforementioned disadvantages of titanium osteosyntheses. However, disadvantages of biodegradable systems include decreased mechanical properties and possible foreign body reactions. In this review, the literature that focused on the in vitro and in vivo performances of biodegradable and titanium osteosyntheses is discussed. The focus was on factors underlying the favorable clinical outcome of osteosyntheses, including the degradation characteristics of biodegradable osteosyntheses and the host response they elicit. Furthermore, recommendations for clinical usage and future research are given. Based on the available (clinical) evidence, biodegradable copolymeric osteosyntheses are a viable alternative to titanium osteosyntheses when applied to treat maxillofacial trauma, with similar efficacy and significantly lower symptomatic osteosynthesis removal. For orthognathic surgery, biodegradable copolymeric osteosyntheses are a valid alternative to titanium osteosyntheses, but a longer operation time is needed. An osteosynthesis system composed of an amorphous copolymer, preferably using ultrasound welding with well-contoured shapes and sufficient mechanical properties, has the greatest potential as a biocompatible biodegradable copolymeric osteosynthesis system. Future research should focus on surface modifications (e.g., nanogel coatings) and novel biodegradable materials (e.g., magnesium alloys and silk) to address the disadvantages of current osteosynthesis systems.

Biocompatibility and degradation comparisons of four biodegradable copolymeric osteosynthesis systems used in maxillofacial surgery: A goat model with four years follow-up.

Applying biodegradable osteosyntheses avoids the disadvantages of titanium osteosyntheses. However, foreign-body reactions remain a major concern and evidence of complete resorption is lacking. This study compared the physico-chemical properties, histological response and radiographs of four copolymeric biodegradable osteosynthesis systems in a goat model with 48-months follow-up. The systems were implanted subperiosteally in both tibia and radius of 12 Dutch White goats. The BioSorb FX [poly(70LLA-co-30DLLA)], Inion CPS [poly([70–78.5]LLA-co-[16–24]DLLA-co-4TMC)], SonicWeld Rx [poly(DLLA)], LactoSorb [poly(82LLA-co-18GA)] systems and a negative control were randomly implanted in each extremity. Samples were assessed at 6-, 12-, 18-, 24-, 36-, and 48-month follow-up. Surface topography was performed using scanning electron microscopy (SEM). Differential scanning calorimetry and gel permeation chromatography were performed on initial and explanted samples. Histological sections were systematically assessed by two blinded researchers using (polarized) light microscopy, SEM and energy-dispersive X-ray analysis. The SonicWeld Rx system was amorphous while the others were semi-crystalline. Foreign-body reactions were not observed during the complete follow-up. The SonicWeld Rx and LactoSorb systems reached bone percentages of negative controls after 18 months while the BioSorb Fx and Inion CPS systems reached these levels after 36 months. The SonicWeld Rx system showed the most predictable degradation profile. All the biodegradable systems were safe to use and well-tolerated (i.e., complete implant replacement by bone, no clinical or histological foreign body reactions, no [sterile] abscess formation, no re-interventions needed), but nanoscale residual polymeric fragments were observed at every system's assessment.

Comparison of the mechanical properties of biodegradable and titanium osteosynthesis systems used in oral and maxillofacial surgery

To guide the selection of osteosynthesis systems, this study compared the mechanical properties of biodegradable and titanium osteosynthesis systems. SonicPins Rx and xG were subjected to pull-out tests. Additionally, 15 biodegradable (Inion CPS 2.0 and 2.5 mm; LactoSorb 2.0 mm; Macropore 2.0 mm; Polymax 2.0 mm; BioSorb FX 2.0 mm; ResorbX 2.1 mm; Osteotrans-MX 2.0 mm with plate thicknesses 1.0 and 1.4 mm; SonicWeld Rxplate/Rxpins, xGplate/Rxpins and xGplate/xGpins 2.1 mm without and with tapping the burr hole) and six titanium (CrossDrive (2006), CrossDrive (2018), MaxDrive; all 1.5 and 2.0 mm) straight, four-hole osteosynthesis systems were evaluated. All systems were subjected to tensile, bending and torsion tests. Pull-out loads of the SonicPins were comparable (P = 0.423). Titanium systems’ tensile loads were higher than biodegradable systems (P < 0.001). CrossDrive (2018) and MaxDrive systems’ tensile and torsional stiffness were lower, accompanied with higher ductility, than corresponding CrossDrive (2006) systems (P < 0.001). Bending stiffness of 1.5 mm titanium systems was comparable to, and of the 2.0 mm systems higher than, all biodegradable systems (P < 0.001). Regarding biodegradable systems, Inion CPS 2.5 mm had highest tensile load and torsional stiffness, SonicWeld 2.1 mm highest tensile stiffness, and BioSorbFX 2.0 mm highest bending stiffness (P < 0.001). On the basis of the results of this study, the CrossDrive (2018) and MaxDrive 1.5 mm titanium systems are recommended for midface fractures (e.g., zygomatic or maxillary fractures) and osteotomies (e.g., Le Fort I osteotomy), and the CrossDrive (2018) and MaxDrive 2.0 mm titanium systems for mandibular fractures and osteotomies when a titanium osteosynthesis system is used. When there is an indication for a biodegradable osteosynthesis system, the SonicWeld 2.1 mm or BioSorbFX 2.0 mm are recommended for midface fractures and osteotomies, and the Inion CPS 2.5 mm biodegradable system for mandibular osteotomies and non-load bearing mandibular fractures, especially when high torsional forces are expected (e.g., mandibular symphysis fractures).

Biodegradable versus titanium osteosynthesis in maxillofacial traumatology: a systematic review with meta-analysis and trial sequential analysis

Titanium osteosynthesis is currently the fixation system of choice in maxillofacial traumatology. Biodegradable osteosynthesis systems have the ability to degrade in the human body. The aim of this study was to conduct a systematic review, with meta- and trial sequential analyses, to assess the efficacy and morbidity of biodegradable versus titanium osteosynthesis after maxillofacial trauma. MEDLINE, Embase, and CENTRAL were searched for randomized controlled trials and prospective and retrospective controlled studies. Five time periods were studied: perioperative, short-term (0–4 weeks), intermediate (6–12 weeks), long-term (>12 weeks), and overall follow-up. After screening 3542 records, 24 were included. All had a high risk of performance and detection bias due to the nature of the interventions. Meta-analysis showed no differences in efficacy or morbidity between biodegradable and titanium osteosynthesis. The risk of perioperative screw breakage was significantly higher (risk ratio 17.13, 95% confidence interval 2.19–34.18) and the symptomatic plate removal rate lower in the biodegradable group (risk ratio 0.11, 95% confidence interval 0.02–0.57), which was confirmed by the trial sequential analysis. The quality of evidence ranged from very low to moderate. Based on the narrative review and meta-analyses, current evidence shows that biodegradable osteosynthesis is a viable alternative to titanium osteosynthesis when applied in the treatment of maxillofacial trauma, with similar efficacy but significantly lower symptomatic plate removal rates. Perioperative screw breakage occurred significantly more often in the biodegradable group compared to the titanium group.

Fixation of zygomatic and mandibular fractures with biodegradable plates

Context:In this prospective study, 13 randomly selected patients underwent treatment for zygomatic–complex fractures (2 site fractures) and mandibular fractures using 1.5 / 2 / 2.5-mm INION CPS biodegradable plates and screws.Aims:To assess the fixation of zygomatic-complex and mandibular fractures with biodegradable copolymer osteosynthesis system.Materials and Methods:In randomly selected 13 patients, zygomatic-complex and mandibular fractures were plated using resorbable plates and screws using Champy's principle. All the cases were evaluated clinically and radiologically for the type of fracture, need for the intermaxillary fixation (IMF) and its duration, duration of surgery, fixation at operation, state of reduction at operation, state of bone union after operation, anatomic reduction, paresthesia, occlusal discrepancies, soft tissue infection, immediate and late inflammatory reactions related to biodegradation process, and any need for the removal of the plates.Statistical Analysis Used:Descriptives, Frequencies, and Chi-square test were used.Results:In our study, the age group range was 5 to 55 years. Road traffic accidents accounted for the majority of patients six, (46.2%). Postoperative occlusal discrepancies were found in seven patients as mild to moderate, which resolved with IMF for 1-8 weeks. There were minimal complications seen and only as soft tissue infection.Conclusions:Use of biodegradable osteosynthesis system is a reliable alternative method for the fixation of zygomatic-complex and mandibular fractures. The biodegradable system still needs to be refined in material quality and handling to match the stability achieved with metal system. Biodegradable plates and screws is an ideal system for pediatric fractures with favorable outcome.

Evaluating the Applicability of a Biodegradable Osteosynthesis Plating System in the Management of Zygomatico‐Maxillary Complex Fractures

The present study was undertaken to evaluate and analyze the efficacy of bioresorbable plates and screws in internal fixation of zygomatico-maxillary complex (ZMC) fractures and to evaluate the incidence of complications associated with the procedure. Case series with planned data collection. Pt BD Sharma University of Health Sciences. A total of 14 patients with isolated ZMC fractures were included, and exclusion of grossly comminuted, pathological, and infected fractures was done. Open reduction internal fixation was done with biodegradable plates and screws. All patients were reviewed clinically and radiographically at regular follow-up. Occlusion, stability of fracture segments, anesthesia or paresthesia of the infraorbital nerve region, and various complications were assessed periodically. Fourteen patients with 34 fracture sites were included in the study. Intraoperatively, there were 2 incidences of screw head fracture. As observed clinically, there was complete stability of fracture segments, and no maxillomandibular fixation was required postoperatively. Paresthesia of the infraorbital nerve was present in 5 patients, but the sensation recovered completely in the first 3 months after surgery. The mean pain score was 3 on a visual analogue scale. In 1 case, ectropion developed, and dehiscence occurred in another patient in the early postoperative period. Postoperative radiographs were evaluated for the accuracy of fracture reduction and stability of fixation. The biodegradable osteosynthesis system exhibits adequate strength and has negligible complications. This system is technique sensitive with satisfactory results in the management of mild to moderately displaced ZMC fractures.

Clinical Experiences With Resorbable Ultrasonic-Guided, Angle-Stable Osteosynthesis in the Panfacial Region

In this study we report our experiences with the treatment of midfacial fractures and various other indications in regions with low load bearing (eg, dysmorphias) using the biodegradable Osteosynthesis System (SonicWeld Rx by KLS Martin, Tuttlingen, Germany), comprising biomechanical and histological aspects. Seventy-five patients were included in this study. We describe the application of this system for the treatment of fractures of the zygomamaxillary complex, frontal bone impression fractures, surgical treatment of mukocele in the frontal sinus, isolated fractures of the orbital floor, complex midfacial trauma and bone cap fixation, craniosynostoses, and fixation of a distracted bone fragment. The pin insertion could be finished with a total failure rate of lower than 5%. In 3 patients, soft tissue swellings in regions with less subcutaneous fat were observed 6 to 8 months postoperatively. No fracture dislocations occurred. Scanning electron micrograph of the experimentally acquired connection between the resorbable plate and 2 pins clearly demonstrates a tight and reliable fusion to bone, both at the cortical as well as at the spongy compartment. Conventional histology leads to corresponding findings as scanning electron micrography, and shows a close fusion between all components. This retrospective study shows the general feasibility, sufficient mechanical stability, and efficient intraoperative handling of this angle-stable, ultrasonic-guided resorbable Osteosynthesis System (ResorbX and SonicWeld Rx) for a wide variety of indications in craniomaxillofacial surgery.

Bone welding – A histological evaluation in the jaw

The expansion of biodegradable osteosynthesis systems in clinical application correlates well to the progress in development of new materials as to the improvement of application methods. One of those new application methods is the ultrasound-aided insertion of Resorb-X pins. The aim of this study was the histological evaluation of possible thermal damage to bone due to the ultrasound insertion. For this purpose, condylar neck fractures in 12 sheep were produced, repositioned and fixed by Resorb-X plates and pins. The animals were sacrificed in two groups, one after 2 weeks and one after 9 weeks. The bone-pin interlinkage and the structure of the bone were histologically evaluated. After 2 weeks a tight bone-polymer interlinkage was seen. Neither a pronounced foreign body reaction nor an interposition of fibrous tissue at the interface or a thermally induced necrosis was observed. The late phase of wound healing after 9 weeks showed pathomorphological characteristics within the normal range of bone healing. The bone seemed to be free of any alteration caused by process engineering. We conclude that thermal stress caused by ultrasound-aided pin insertion does not lead to cellular reaction in the bone. The fast and easy application of this improved biodegradable osteosynthesis system will bring a clear advantage in clinical use.

Self-reinforced biodegradable plates and screws for fixation of zygomatic fractures

The aim of this retrospective clinical study was to evaluate zygomatic fracture fixation with the BioSorbFX osteosynthesis system by assessing stability of reduction as well as complications in the first postoperative year and by conducting a survey to document surgeons' opinions on biodegradable osteosynthesis for this indication. From January to September 2003, 25 patients with displaced non-infected unilateral fracture of the zygoma were operated upon (m:f = 20:5; age 17-81 years; mean 39.4 years) using the BioSorbFX 2.0 and/or 1.5 mm osteosynthesis systems. A: Clinical and radiographic examinations were carried out immediately postoperatively and after 1, 3, 6, 9 and 12 months. B: Surgeons were asked to participate in a survey critically evaluating their experience with biodegradable osteosynthesis systems. A: All fractures of the zygoma healed uneventfully. An excessive soft tissue reaction due to the degradation process was not seen. Three minor complications which resolved after local therapy occurred in the immediate postoperative phase. B: In the survey, the handling of biodegradable plates in general was rated worse than metal plate osteosynthesis. Fixation of fractures of the zygoma with the BioSorbFX system was simple and safe. The fixations remained stable and bony healing was uneventful. Postoperative complications were few, of a minor nature and not related to the process of biodegradation.

Biodegradable osteosynthesis system for maxillofacial surgery

Biodegradable osteosynthesis system for maxillofacial surgery