• Maxillofacial Plastic and Reconstructive Surgery
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• 제37권
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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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• 제32권1호
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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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• 제36권4호
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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.

• 대한의용생체공학회:의공학회지
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• 제44권6호
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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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• 제32권2호
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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.

• 대한관절경학회지
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• 제6권2호
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• pp.150-155
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• 2002

목적 : 반월상 연골 봉합 수술에서 생체 흡수성 기구를 이용한 방법의 유용성에 대해 알아보고자 하였다. 대상 및 방법 : 1998년부터 생체 흡수성 기구를 이용한 반월상 연골 봉합술을 시행한 후 1년 이상 추시가 가능했던 21예를 대상으로 하였다. 사용된 기구는 Meniscus $Arrow^{\circledR}$(Bionx)와 Meniscal $Fastener^{\circledR}$(Mitek)였으며 전예에서 후각부의 종파열 환자만을 선택하였고, 동측 전방 십자 인대 파열이 있었던 9예는 연골판 봉합과 동시에 재건술을 시행하였다 결과는 Lysholm score로 평가하였다. 결과 : Lysholm score는 전체 술 전 평균 56점에서 술 후 평균 89점으로 향상 되었고, red-red zone 파열군과 red-white zone 파열군 및 각기 다른 기구를 사용한 군 사이에서는 상이한 차이가 없었으나, 전방 십자 인대 파열후 재건술을 동시에 시행한 경우와 수상 후 8주 이전에 수술한 경우에서 결과가 더 좋았다. 결론 : 생체 흡수성 기구를 이용한 방법은 잘 선택된 환자에서 제한적으로 사용할 경우, 특히 전방 십자 인대 재건술을 동시에 시행할 때 유용하리라 사료된다.

• 대한족부족관절학회지
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• 제22권4호
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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).

• 한국임상수의학회지
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• 제24권2호
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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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• 제37권5호
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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.

• 대한정형외과스포츠의학회지
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• 제1권1호
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• pp.21-25
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• 2002

목적: 슬괵건과 대퇴부의고정을 위해새로이 고안된Ligament Anchor (LA) 나사를이용한전방십자인대재건술후 임상결과에평가하고자하였다. 대상및방법: 슬괵건4가닥과LA 나사를이용하여전방십자인대재건술후최소2년이상추시가능하였던 58예를대상으로하였다. 이식건의 고정으로 대퇴골측은 LA나사를, 경골측은 생흡수성 간섭나사를 이용하였다. 평균 추시기간은 28개월이었다. 임상적결과로는 Lachmann 검사와Lysholm 점수를이용하였으며 방사선학적 결과로는 Telos(R) 기기(Telos stress device; Austin & Associates, Inc., Polston, US)를 이용한 전방 전위방사선 사진을 촬영하여 건측과의 전방이완도 차이와 골터널확대정도를평가하였다. 결과: Lysholm 점수는술전평균6 0점에서술후평균94.0점으로호전되었으며, 술전Lachmann 검사상 16예에서 경도의양성, 24예에서중등도, 18예에서 고도의 양성 소견을 보였으며, 술 후 Lachmann 검사상50예는 음성이었으며, 8예에서만 경도의 양성소견을 보였다. Telos(R) 기기를 이용한 전방전위 검사상 건측과의 차이는 술 전 평균12.9 mm에서 최종 추시상 3.1 mm로호전되었다(p<0.05). 대퇴터널은전후방방사선사진상수술직후10.6 mm에서최종추시상12.7 mm(21.1$\%$ )로확장되었으며, 측면방사선사진상술후10.7 mm에서최종추시상12.4 mm(16.5$\%$)로확장되었다(p<0.05). 경골터널은전후방방사선사진상술후9.8 mm에서최종추시상11.8 mm(20.7$\%$)로확장되었으며측면방사선사진상술후9.9 mm에서최종추시상11.7 mm(18.9$\%$)로확장되었다(p<0.05) .결론: 슬괵건과L A나사를이용한전방십자인대재건술은임상성적이우수하며, 슬관절전방동통이나골터널확장등의합병증이적어슬관절의전방안정성을회복하는데좋은이식물및내고정물이라생각된다.