ASTM F3108 PDF
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Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
Published by | Publication Date | Number of Pages |
ASTM | 04/01/2019 | 7 |
ASTM F3108 – Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registriesfor Knee Reconstructive Surgery
1.1 This guide is intended as a resource for individuals and organizations when designing clinical trials and/or clinical registries and addresses the selection of patient-reported outcomes, safety outcomes, imaging outcomes and other topics related to knee reconstructive surgery (KRS) including: (1) knee replacement systems, (2) anterior cruciate ligament reconstruction, (3) knee meniscus implants or tissue engineered medical products (TEMPs), (4) articular cartilage implants or TEMPS, (5) peri-articular knee osteotomies, (6) peri-articular knee fractures (including distal femur, patella, and proximal tibia fractures), or other knee surgeries.
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