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Significance and Use
5.1 Approximately 300,000 primary total hip arthroplasties (THAs) and 50,000 revision THAs are performed in the United States annually (. In addition, approximately 50 % of the 300,000 hip fractures in the United States annually are femoral neck fractures. The majority of femoral neck fractures are treated with hip hemiarthroplasties (femoral head replacement only). , )
1.1 This guide is intended as a resource for individuals and organizations involved in designing clinical trials of hip replacement systems (HRSs) including metal/polymer, metal/metal, metal/composite, metal/ceramic/polymer, metal/polymer/metal, and ceramic/ceramic bearing surfaces; semi-constrained and constrained designs; and cemented, nonporous uncemented, and porous-coated uncemented fixation.
1.2 In this guide, methods to measure the efficacy, effectiveness, and safety of HRS devices through standardizing outcomes 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 coverage approval for hip replacement systems to the health care market.
1.4 For the purpose of this guide, an HRS is any device that is intended to replace the hip joint, in part or in total, as a treatment for joint disease, trauma, or dysfunction, where long-term functional restoration 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 and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ISO StandardsISO 12891-1 Retrieval and analysis of surgical implants - Part1: Retrieval and handling ISO 12891-2 ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice ISO 14971 Medical devices - Application of risk management to medical devices
F561 Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
F2809 Terminology Relating to Medical and Surgical Materials and Devices
F2978 Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
F2979 Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42321707(Total hip replacement kit or system)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM F3037-15, Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs), ASTM International, West Conshohocken, PA, 2015, www.astm.orgBack to Top