• Archives of Craniofacial Surgery
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• v.19 no.2
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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.

• 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.

• 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 Korean Foot and Ankle Society
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• v.13 no.1
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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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• v.29 no.3
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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.

• Journal of the Korean Arthroscopy Society
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• v.5 no.2
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• pp.69-73
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• 2001

Purpose : To evaluate the clinical results and widening of bony tunnel after anterior cruciate ligament(ACL) reconstruction using hamstring tendon with Ligament Anchor(LA) screw, which is newly designed fur 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 were included in this study. The graft was fixed with LA screw at femoral tunnel and with bioabsorbable interference screw at tibial tunnel. The average period of follow-up was 28 months. The clinical results such as physical examination and Lysholm knee score and radiological results. widening of bony tunnel and instrumented anterior laxity test with $Telos^{\circledR}$(Telos stress device; Austin & Associates, Inc., Polston, US) were evaluated. Results . The Lysholm knee score was 60.0 in average preoperatively and improved to 94.0 in average at 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 follow up. On instrumented anterior laxity test with $Telos^{\circledR}$, side to side difference in 20 lb was 12.9mm in average preoperatively, and was decreased to 3.1mm in average follow-up. The femoral tunnel was widened from 10.6mm postoperatively to 12.7mm$(21.1\%)$ at follow up on antero-posterior plane and from 10.7mm to 12.4mm$(16.5\%)$ 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 11.7mm$(18.9\%)$ in lateral plane. Conclusion : ACL reconstruction with hamstring tendon and LA screw was one of the choice of grafts and fixatives in restoring knee stability and in improving clinical results with little complications such as excessive widening of bony tunnel.

• 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