• Maxillofacial Plastic and Reconstructive Surgery
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• v.37
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• pp.6.1-6.9
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• 2015

Orthognathic surgery requires stable fixation for uneventful healing of osteotomized bony segments and optimal remodeling. Titanium plates and screws have been accepted as the gold standard for rigid fixation in orthognathic surgery. Although titanium osteofixation is the most widely used approach, the use of bioabsorbable devices has been increasing recently. Biodegradation of bioabsorbable devices eliminates the need for a second operation to remove metal plates and screws. However, long-term stability and relapse frequency in bioabsorbable osteofixation are still insufficiently studied, especially in cases of segmental movements of great magnitude or segmental movements to a position where bony resistance exists. This paper reviews the background, techniques, and complications of bioabsorbable osteofixation and compares bioabsorbable and titanium osteofixation in orthognathic surgery in terms of skeletal stability.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• v.32 no.1
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• pp.60-64
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• 2006

Backgrounds: Though they are considered as reliable devices, titanium plates and screws have limitations due to some potential problems. To overcome these problems, researches on bioabsorbable materials for internal fixation have been continuing. Recently, there are many clinical trials to apply biodegradable internal fixation devices in oral and maxillofacial surgery. The purpose of this study was to evaluate the clinical results of application of bioabsorbable plates and screws in orthognathic surgery. Methods: Fifty-four patients with dentofacial deformity (17 male patients and 37 female patients) were selected in this study. The patients were treated by internal fixation using bioabsorbable plates and 2.4-mm, 2.0-mm pretapped screws (Biosorb FX, Bionix Implants, Inc., Finland). The patients were evaluated for complications during the follow-up period. Results: Five patients (9.3%) experienced complications. All complications in these cases were infection. No other complications related with physical or mechanical properties of bioabsorbable plates were found such as malunion or nonunion, fractures of plates and loosening of screws. All complications were minor and adequately managed with drainage and supportive care with antibiotics coverage. Conclusions: From the results, the use of these fixation systems in orthognathic surgery will provide a promising alternative titanium fixation in appropriate cases.

• Maxillofacial Plastic and Reconstructive Surgery
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• v.36 no.4
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• pp.178-183
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• 2014

Lip canting is associated with facial asymmetry, and is one of the most challenging problems in surgical correction of facial deformities. The author corrected lip canting using bioabsorbable devices during orthognathic surgery. Soft tissue suspension procedures were performed on four patients with facial asymmetry. Lip lines improved for all patients. Over an observation period of five years, no complications were noted, nor did any late relapse develop. Furthermore, as time past, the effect of the Endotine suspension procedure increased probably due to induction of fibrosis on surrounding soft tissues.

• Journal of Biomedical Engineering Research
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• v.44 no.6
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• pp.414-427
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• 2023

Implantable bioabsorbable combination products undergo inherent degradation and systemic absorption within the physiological environment, thereby streamlining the therapeutic regimen and obviating the imperative for invasive extraction procedures. This inherent property not only enhances patient convenience and therapeutic efficacy but also underpins a paradigm of support characterized by heightened safety parameters. Within the regulatory landscapes of Korea, the United States, and Europe, implantable bioabsorbable combination products are meticulously classified into distinct categories, either as pharmaceutical implants or as implantable medical devices, depending on their primary mode of action. This scholarly investigation systematically examines the regulatory frameworks governing implantable bioabsorbable combination products in South Korea, the United States, and Europe. Notable discrepancies across national jurisdictions emerge concerning regulatory specifics, including terminology, product classification, and product name associated with these products. The conspicuous absence of standardized approval regulations presents a formidable barrier to the commercialization of these advanced medical devices. This academic discourse passionately emphasizes the critical need for formulating and implementing a sophisticated regulatory framework capable of streamlining the product approval process, thereby paving the way for a seamless path to commercializing implantable bioabsorbable combination products.

• Archives of Plastic Surgery
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• v.32 no.2
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• pp.227-230
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• 2005

The surgical treatment of craniofacial disorders, using metallic internal osteofixation system has inspired an evolution with advanced operative technique and fixation devices over past two decades. As any other surgical procedures, this procedure also associates problems such as infection, palpability, loosening, and restrict craniofacial skeleton growth, which lead to undue secondary operations for removal. These problems are improved by using bioabsorbable osteofixation system. We compared the patient's subjective symptoms using bioaborbable system versus metallic osteofixation system in zygomatic bone fracture. we should take the individual steps (postoperative 2 weeks, and 1 year) in treating fractured zygoma. From August, 2001 to August, 2003, we used bioabsorbable osteofixation system in 28 patients in zygomatic fracture ($Biosorb^{TM}FX^{(R)}$) and compared 23 patients who were treated with metallic osteofixation system. There was no significant difference in the both groups in subjective symptoms and postoperative result.

• Journal of the Korean Arthroscopy Society
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• v.6 no.2
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• pp.150-155
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• 2002

Purpose : The purpose of this study was to evaluate the clinical results of meniscal repair using the bioabsorbable devices. Materials and Methods : From 1998, 21 meniscal repairs were underwent using the bioabsorbable devices and followed more than 1 year. The Meniscus $Arrow^{\circledR}$(Bionx) and the Meniscal $Fastener^{\circledR}$(Mitek) had been applied. The indication for meniscus refixation was an unstable longitudinal tear in the posterior horn of the medial or lateral meniscus. Concurrent ACL reconstruction with meniscal repair was performed on 9 knees. The clinical result was evaluated using Lysholm knee score. Result : The average Lysholm knee scores for all patients improved from 56 preoperatively, to 89 postoperatively. The type of the device were not significantly related to clinical outcome or Lysholm knee score. But the concurrent ACL reconstruction group and the patients treated within 8 weeks had better clinical result than the others. Conclusion : The all-inside meniscal repair technique using bioabsorbable devices can be considered to be an useful method in the well selected patients and concurrent ACL reconstruction surgery.

• Journal of Korean Foot and Ankle Society
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• v.22 no.4
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• pp.181-183
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• 2018

Hallux valgus is a deformity that causes pain in the first metatarsophalangeal joint. Surgical methods are quite diverse and a range of osteotomies are used at the proximal and distal part of the metatarsal bone and proximal phalange. Fixation methods, such as plate, screw, K-wire, and others have been used in various ways. The fixation device is often removed with various side effects due to the fixation devices. In the case of instruments that are absorbed in vivo, these procedures are not necessary to remove and there is an advantage of not performing the second operation. Three patients were treated, in which a proximal chevron osteotomy was used with a bioabsorbable screw (K-$MET^{TM}$; U&I Corporation).

• Journal of Veterinary Clinics
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• v.24 no.2
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• pp.182-191
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• 2007

Bioabsorbable devices have been utilized and experimented in many aspects of orthopaedic surgery. Depending upon their constituent polymers, these materials can be tailored to provide sufficient rigidity to allow bone healing, retain mechanical strength for certain period of time, and then eventually begin to undergo degradation. The objective of this study was to estimate extent in which Poly-L-latic acid (PLLA) implants had bioabsorbability and biocompatibility with bone and soft tissue in dogs and also to develop bioabsorbable, biocompatible materials with the appropriate strength and degradation characteristics to allow for regular clinical use for treating orthopedic problems in humans as well as animals. Eighteen dogs were used as experimental animals and were inserted two types of PLLA implants. PLLA rods were inserted into subcutaneous tissue of back or the abdomen wall. And the rods were tested for material properties including viscosity, molecular weight, melting point, melting temperature, crystallinity, flexural strength, and flexural modulus over time. PLLA screws were inserted through cortical bone into bone marrow in the femur of the dogs and stainless steel screw was inserted in the same femur. Radiographs were taken after surgery to observe locations of screw. Histological variations including cortical bone response, muscular response, bone marrow response were analyzed over the time for 62weeks. The physical properties of PLLA rods had delicate balances between mechanical, thermal and viscoelastic factors. PLLA screws did not induce any harmful effects and clinical complications on bone and soft tissue for degradation period. These results suggest that PLLA implants could be suitable for clinical use.

• Archives of Plastic Surgery
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• v.37 no.5
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• pp.717-720
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• 2010

Purpose: Absorbable plate and screw fixation is widely used technique for internal rigid fixation in craniomaxillofacial surgery. However, there are some potential problems associated with the use of plate. The purpose of this study is to evaluate the feasibility of bone fixation in facial fracture using absorbable mesh in place of absorbable plate. Methods: The records of 55 patients with zygomaticomaxilla fractures treated by open reduction, performed by the author from February 2008 to May 2009, were retrospectively reviewed. Patients were selected to receive absorbable mesh fixation. The incidence of all complications including infection, hypoesthesia, and deformity was examined. Analysis with postoperative computed tomography follow-up demonstrates degree of reduction. Results: Forty-six patients met criteria for inclusion in the study. All patients went on to satisfactory healing without complication. Postoperative computed tomography revealed good bony alignment similarly non affected side. Conclusion: This study demonstrates that the rigid internal fixation of fractured bone fragments using absorbable mesh is more effective than absorbable plate, especially in comminuted fracture of maxilla.

• Journal of Korean Orthopaedic Sports Medicine
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• v.1 no.1
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• pp.21-25
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• 2002

Purpose: To evaluate the clinical results after anterior cruciate ligament (ACL) reconstruction with hamstring tendon and Ligament Anchor (LA) screw, which is newly designed for fixation of graft into femur. Materials and Methods: Fifty eight patients who were followed up at least more than 2 years after ACL reconstruction with four strands of Hamstring tendon and LA screw were included in this study. The graft was fixed with LA screw at femoral tunnel and with only bioabsorbable interference screw at tibial tunnel. The mean follow-up period was 28 months. The clinical results were evaluated by physical examination and Lysholm knee score. Widening of bony tunnel and anterior laxity difference compared with normal side by instrumented anterior laxity test with Telos(R) (Telos stress device; Austin & Associates, Inc., Polston, US) were evaluated. Results: The Lysholm knee score improved from 60.0 points preoperatively to 94.0 points at last follow up. On the Lachman test, there were mild (+) instability in 16 cases, moderate (++) in 24,severe (+++) in 18 preoperatively. 50 cases were converted to negative and 8 to mild instability at postoperative follow up. On instrumented anterior laxity test with Telos(R), difference between normal and affected knee on 20 lb was 12.9 mm in average preoperatively, and was decreased to 3.1mm at last follow-up. The femoral tunnel was widened from 10.6 mm postoperatively to 12.7 mm (21.1$\%$) at follow up on antero-posterior plane and from 10.7 mm to 12.4 mm (16.5$\%$) on lateral plane. Tibial tunnels was also widened from 9.8mm to 11.8mm (20.7$\%$) on antero-posterior plane and from 9.9mm to 11.7 mm ($18.9\%$) on lateral plane. Complications were: anterior knee crepitus in 17 case, quadriceps muscle atrophy(>3 cm) in 6, penetration of screw over the lateral femoral cortex in 5, saphenous nerve paresthesia in 2.Conclusions: ACL reconstruction with hamstring tendon and LA screw was one of the choice of grafts and fixation devices in restoring knee stability and in improving clinical results with little complications such as excessive widening of bony tunnel and anterior knee pain