ASTM F3037-15
(Guide)Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs) (Withdrawn 2020)
Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs) (Withdrawn 2020)
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 (5, 6). 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).
SCOPE
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.
WITHDRAWN RATIONALE
This guide was intended as a resource for individuals and organizations involved in designing clinical trials of hip replacement systems (HRSs).
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this guide was withdrawn in June 2020. This guide is being withdrawn without replacement due to its limited use by industry.
General Information
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F3037 − 15
Standard Guide for
1
Clinical Trial Design for Hip Replacement Systems (HRSs)
This standard is issued under the fixed designation F3037; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope Devices using Magnetic Resonance Imaging
F2979 Guide for Characterization of Wear from the Articu-
1.1 This guide is intended as a resource for individuals and
lating Surfaces in Retrieved Metal-on-Metal and other
organizations involved in designing clinical trials of hip
Hard-on-Hard Hip Prostheses
replacement systems (HRSs) including metal/polymer, metal/
3
2.2 ISO Standards
metal, metal/composite, metal/ceramic/polymer, metal/
ISO 12891-1 Retrieval and analysis of surgical implants –
polymer/metal, and ceramic/ceramic bearing surfaces; semi-
Part1: Retrieval and handling
constrained and constrained designs; and cemented, nonporous
ISO 12891-2 Retrieval and analysis of surgical implants –
uncemented, and porous-coated uncemented fixation.
Part 2: Analysis of retrieved surgical implants
1.2 In this guide, methods to measure the efficacy,
ISO 14155 Clinical investigation of medical devices for
effectiveness,andsafetyofHRSdevicesthroughstandardizing
human subjects – Good clinical practice
outcomes measures are provided for designing, reviewing, and
ISO 14971 Medical devices – Application of risk manage-
accepting human clinical trial protocols.
ment to medical devices
1.3 This guide is intended to provide consistency in study
design, review, regulatory approval, and coverage approval for 3. Terminology
hip replacement systems to the health care market.
3.1 Unless provided in 3.2.1 – 3.2.5, definitions shall be in
1.4 For the purpose of this guide, an HRS is any device that conformance with Terminology F2809.
is intended to replace the hip joint, in part or in total, as a
3.2 Definitions:
treatment for joint disease, trauma, or dysfunction, where
3.2.1 coverage, n—insurance decision to reimburse for a
long-term functional restoration and pain relief without major
device and/or procedure.
adverse events are the desired outcomes.
3.2.2 effectiveness, n—extent to which medical interven-
1.5 This standard does not purport to address all of the
tions achieve health improvements in real practice settings.
safety concerns, if any, associated with its use. It is the
3.2.3 effıcacy, n—extent to which medical interventions
responsibility of the user of this standard to establish appro-
achieve health improvements under ideal circumstances.
priate safety and health practices and determine the applica-
3.2.4 level of evidence—strength of clinical evidence for
bility of regulatory limitations prior to use.
4
evidence-based medicine (1) .
2. Referenced Documents
3.2.5 safety—the condition of being protected from or
2
2.1 ASTM Standards:
unlikely to cause risk or injury. See Appendix X1 for a
F561 Practice for Retrieval and Analysis of Medical
tabulated list of adverse events reported for hip replacement
Devices, and Associated Tissues and Fluids
systems (2).
F2809 Terminology Relating to Medical and Surgical Mate-
3.3 Acronyms:
rials and Devices
AJRR—American Joint Replacement Registry
F2978 Guide to Optimize Scan Sequences for Clinical Di-
ASA—American Society of Anesthesiologists
agnostic Evaluation of Metal-on-Metal Hip Arthroplasty
DVT—Deep Vein Thrombosis
EQ-5D—European Quality of Life – 5 Domains
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
FDA—Food and Drug Administration
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
HHS—Harris Hip Score
F04.39 on Human Clinical Trials.
Current edition approved June 1, 2015. Published August 2015. DOI: 10.1520/
F3037-15.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Standards volume information, refer to the standard’s Document Summary page on The boldface numbers in parentheses refer to a list of references at the end of
the ASTM website. this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F3037 − 15
HOOS—Hip dysfunction and Osteoarthritis Outcome 4.4 The application of this guide does not guarantee clinical
Score success of a finished product but will help to ensure consis-
tency and adequacy in the clinical data of the clinic
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.