인공발목관절의 임상시험 가이드라인 개발을 위한 문헌적 고찰

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.