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인공발목관절의 임상시험 가이드라인 개발을 위한 문헌적 고찰
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 박진오 | - |
dc.contributor.author | 이모세 | - |
dc.contributor.author | 이진우 | - |
dc.contributor.author | 한승환 | - |
dc.date.accessioned | 2015-12-28T10:59:46Z | - |
dc.date.available | 2015-12-28T10:59:46Z | - |
dc.date.issued | 2014 | - |
dc.identifier.issn | 1738-3757 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/138469 | - |
dc.description.abstract | Purpose: The purpose of this study is to develop guidelines for clinical trial of the total ankle replacement system for premarket approval. Materials and Methods: We selected and analyzed nine peer-reviewed articles whose quality had been proven in a previous phase. Two investigators extracted parameters for guideline criteria, including number of cases, patient age, follow-up period, failure rate, radiographic osteolysis rate, residual pain rate, and percentage of satisfaction. In addition, the inclusion and exclusion criteria were analyzed and developed. Results: Eight level IV studies and one level II study were included. The average number of cases was 159 cases and the mean patient age was 63.5 years. The mean follow-up period was 4.2 years, ranging from two to nine. The average failure rate of total ankle replacement in mid- to long-term follow-up was approximately 13% (2%∼32.3%). The rate of osteolysis was approximately 18%. Residual pain was common (21.4%∼46%), but overall patient satisfaction was approximately 85.6% (67.5%∼97%). Conclusion: The results could be used as criteria for designing the clinical studies, such as number of cases, patient age (over 60 years), and follow-up period (minimum two years). The clinical scoring system and 36-item short form health survey (SF-36) was the most commonly used method for clinical evaluation for total ankle arthroplasty. In addition, the overall results, including failure rate, osteolysis rate, and patient satisfaction, could be used as a parameter of guidelines for premarket approval. | - |
dc.description.statementOfResponsibility | open | - |
dc.format.extent | 195~201 | - |
dc.relation.isPartOf | Journal of Korean Foot and Ankle Society (대한족부족관절학회지) | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.title | 인공발목관절의 임상시험 가이드라인 개발을 위한 문헌적 고찰 | - |
dc.title.alternative | Review of Literatures for Development of Clinical Trial Guideline for Total Ankle Arthroplasty | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Orthopedic Surgery (정형외과학) | - |
dc.contributor.googleauthor | 박진오 | - |
dc.contributor.googleauthor | 이모세 | - |
dc.contributor.googleauthor | 이진우 | - |
dc.contributor.googleauthor | 이수빈 | - |
dc.contributor.googleauthor | 한승환 | - |
dc.identifier.doi | 10.14193/jkfas.2014.18.4.195 | - |
dc.admin.author | false | - |
dc.admin.mapping | false | - |
dc.contributor.localId | A01703 | - |
dc.contributor.localId | A02762 | - |
dc.contributor.localId | A03230 | - |
dc.contributor.localId | A04305 | - |
dc.relation.journalcode | J01511 | - |
dc.subject.keyword | Ankle | - |
dc.subject.keyword | Arthritis | - |
dc.subject.keyword | Ankle replacement arthroplasty | - |
dc.subject.keyword | Clinical trial | - |
dc.subject.keyword | Guideline | - |
dc.contributor.alternativeName | Park, Jin Oh | - |
dc.contributor.alternativeName | Lee, Mo Ses | - |
dc.contributor.alternativeName | Lee, Jin Woo | - |
dc.contributor.alternativeName | Han, Seung Hwan | - |
dc.contributor.affiliatedAuthor | Park, Jin Oh | - |
dc.contributor.affiliatedAuthor | Lee, Mo Ses | - |
dc.contributor.affiliatedAuthor | Lee, Jin Woo | - |
dc.contributor.affiliatedAuthor | Han, Seung Hwan | - |
dc.citation.volume | 18 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 195 | - |
dc.citation.endPage | 201 | - |
dc.identifier.bibliographicCitation | Journal of Korean Foot and Ankle Society (대한족부족관절학회지), Vol.18(4) : 195-201, 2014 | - |
dc.identifier.rimsid | 45332 | - |
dc.type.rims | ART | - |
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