• 대한두개안면성형외과학회지
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• 제19권2호
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• pp.143-147
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• 2018

We present a patient who showed a sterile abscess after facial bone fixation with bioabsorbable plates and screws. He had zygomaticomaxillary complex and periorbital fracture due to falling down. The displaced bones were treated by open reduction and internal fixation successfully using bioabsorbable plate system. However, at postoperative 11 months, abrupt painless swelling was noted on the previous operation sites, left lateral eyebrow and lower eyelid. By surgical exploration, pus-like discharge and degraded materials were observed and debrided. The pathologic analysis revealed foreign body reaction with sterile abscess. This complication followed by bioabsorbable device implantation on maxillofacial bone surgery has been rarely reported in which we call attention to the maxillofacial plastic surgeons.

• 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.

• 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).

• 대한족부족관절학회지
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• 제13권1호
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• pp.80-84
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• 2009

Purpose: The purpose of this article is to assess the efficacy of a bioabsorbable polylactide (PLA) plate and screw for treating injuries of ankle fractures. Materials and Methods: 24 patients who underwent an open reduction and internal fixation operation for ankle fractures from July 2005 to March 2007 were enrolled into the study. There were 15 men and 9 women. The average age of the patients was 44 years and the average follow-up period was 16 years and two months (16.2 months). All cases were divided into low grade fracture patient (11) who belongs in type A and B of Danis-Weber classification and high grade fracture patient (13) who belongs in type C1, C2 of Danis-Weber classification, and each groups were analyzed by clinical (Meyer score) and radiological finding at the time of their last follow-up evaluation. Results: The clinical results according to Meyer scoring system, showed that all patient with low grade fracture had good to excellent result, but only 54% of patient with high grade fracture had good to excellent result. According to Cedell's radiologic finding, there were 91% cases above fair in low grade fracture. But there were 62% of patient above fair result in high grade fracture, the reduction losses were seen in 38% of patient with high grade fracture. Conclusion: Bioabsorbable PLA plate and screw is good internal fixation device which doesn't have additional operation for removal of implant because of slow absorption within the human body. It showed sufficient strength for acquisition and maintenance of reduction in low grade fracture, but need attention to use because of many cases of reduction loss in high grade fracture. So, it seems to be safe and effective when used in heeling of low grade fracture under considering about type of fracture sufficiently.

• Journal of Periodontal and Implant Science
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• 제29권3호
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• pp.539-553
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• 1999

The purpose of this 6-months study was to compare the clinical and radiographic outcomes following guided tissue regeneration treating human mandibular Class II furcation defects with a bioabsorbable BioMesh barrier(test treatment) or a nonabsorbable ePTFE barrier(control treatment). Fourteen defects in 14 patients(mean age 44 years) were treated with BioMesh barriers and ten defects in 10 patients(mean age 48 years) with ePTFE barriers. After initial therapy, a GTR procedure was done. Following flap elevation, root planing, and removal of granulation tissue, each device was adjusted to cover the furcation defect. The flaps were repositioned and sutured to complete coverage of the barriers. A second surgical procedure was performed at control sites after 4 to 6 weeks to remove the nonresorbable barrier. Radiographic and clinical examinations(plaque index, gingival index, tooth mobility, gingival margin position, pocket depth, clinical attachment level) were carried out under standardized conditions immediately before and 6 months after surgery. Furthermore, digital subtraction radiography was carried out. All areas healed uneventfully. Surgical treatment resulted in clinically and statistically equivalent changes when comparisons were made between test and control treatments. Changes in plaque index were 0.7 for test and 0.4 for control treatments; changes in gingival index were 0.9 and 0.5. In both group gingival margin position and pocket depth reduction was 1.0mm and 3.0mm; clinical attachment level gain was 1.9mm. There were no changes in tooth mobility and the bone in radiographic evaluation. No significant(p${\leq }$0.05) difference between the two membranes could be detected with regard to plaque index, gingival index, gingival margin position, pocket depth, and clinical attachment level. In conclusion, a bioabsorbable BioMesh membrane is effective in human mandibular Class II furcation defects and a longer period study is needed to fully evaluate the outcomes.

• 대한관절경학회지
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• 제5권2호
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• pp.69-73
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• 2001

목 적 : 대퇴부의 고정을 위해 새로이 고안된 Ligament Anchor(LA) 나사와 슬괵건을 이용한 전방십자인대 재건술 후 임상결과와 골터널의 확장을 평가하고자 하였다. 대상 및 방법 : 슬괵건 4가닥과 LA 나사를 이용하여 전방십자인대 재건술 후 최소 2년 이상 추시 가능하였던 58예를 대상으로 하였다. 이식건의 고정으로 대퇴골측은 LA나사를, 경골측은 생흡수성 간섭나사를 이용하였다 평균 추시기간은 28개월이었다. 임상적 결과로는 Lachmann 검사와 Lysholm 점수를 이용하였으며 방사선학적 결과로는 골터널의 확대정도와 $Telos^{\circledR}$ 기기(Telos stress device; Austin & Associates, Inc., Polston, US)를 이용한 전방 전위 방사선 사진을 촬영하여 건측과의 전방이완도 차이를 평가하였다. 결과 : Lysholm 점수는 술 전 평균 60에서 술 후 평균 94.0점으로 호전되었으며, 술 전 Lachmann 검사상 16예에서 경도의 양성, 24예에서 중등도, 18예에서 고도의 양성 소견을 보였으며, 술 후 Lachmann 검사상 50예는 음성이었으며, 8예에서만 경도의 양성소견을 보였다. $Telos^{\circledR}$ 기기를 이용한 전방전위 검사상 건측과의 차이는 술전 평균 12.9mm에서 최종 추시상 3.1mm로 호전되었다(p<0.05). 대퇴 터널은 전후방 방사선 사진상 수술직후 10.6mm에서 최종 추시상 12.7mm$(21.1\%)$로 확장되었으며, 측면 방사선 사진상 술 후 10.7mm에서 최종 추시상 12.4mm$(16.5\%)$로 확장되었다(p<0.05). 경골 터널은 전후방 방사선 사진상 술 후 9.8mm에서 최종 추시상 11.8mm$(20.7\%)$로 확장되었으며 측면 방사선 사진상 술 후 9.9mm에서 최종 추시상 11.7mm$(18.9\%)$로 확장되었다(p<0.05). 결론 : LA나사와 슬괵건을 이용한 전방십자인대 재건술은 골터널의 확장이 적으며 임상 성적도 우수하여 슬관절의 전방 안정성을 회복하는데 좋은 이식물 및 내고정물이라 생각된다.

• 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.