ASTM F3108 - 19 - Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery

ASTM F3108 - 19

Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery

Status : Current   Published : April 2019

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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.

1.2 In this guide, methods to measure the efficacy, effectiveness, and safety of KRS devices through standardizing clinical outcome measures are provided for designing, reviewing, and accepting human clinical trial protocols.

1.3 This guide is intended to provide consistency in study design, review, regulatory approval, and health insurance coverage approval for knee reconstructive surgery to the health care market.

1.4 For the purpose of this guide, KRS pertains to any device or TEMP that is intended to replace, resurface, reconstruct, and/or provide fixation of the knee joint, in part or in total, as a treatment for joint disease, trauma, or dysfunction, where long-term improvement in function and pain relief without major adverse events are the desired outcomes.

1.5  This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.6  This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.




Standard NumberASTM F3108 - 19
TitleStandard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
StatusCurrent
Publication Date01 April 2019
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors anterior cruciate ligament, clinical trial design, knee arthroplasty, knee cartilage, knee meniscus, knee reconstruction, knee replacement, knee surgery, patella fractures, supracondylar/intercondylar/distal femur fractures, tibial plateau/proximal tibia fractures, tissue engineered medical products
ICS11.040.40
PublisherASTM
FormatA4
DeliveryYes
Pages7
File Size113 KB
Price£40.00


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