Total Artificial Disc Devices - Pre-clinical Testing and Clinical Trial Design Requirements
This guidance provides recommendations for IDE applications for total artificial disc devices, focusing on pre-clinical testing requirements and clinical trial designs to evaluate safety and effectiveness. It specifically applies to total artificial discs only, not to other types of spinal systems or joint replacements.
Recommended Actions
- Develop comprehensive pre-clinical testing plan addressing mechanical, wear, and biocompatibility requirements
- Design clinical study protocol with minimum 2-year follow-up
- Establish clear success criteria for both individual subjects and overall study
- Prepare detailed surgical technique manual and labeling
- Implement retrieval analysis program
- Develop monitoring and data collection procedures
- Create comprehensive risk analysis documentation
- Plan for potential long-term post-approval studies
- Establish metal ion level monitoring for metal-on-metal devices
- Prepare detailed Case Report Forms capturing all required data points
Key Considerations
Clinical testing
- Multi-center, randomized, prospective, concurrently controlled clinical trial recommended
- Minimum 2 years follow-up data required
- Study endpoints should include pain, function, neurological status, and radiographic assessments
- Subject success criteria must account for placebo effect
- Metal ion level analyses required for metal-on-metal devices
Non-clinical testing
- Static and dynamic mechanical characterization testing
- Durability and wear testing with particle analysis
- Subluxation and expulsion risk assessment
- Creep and stress relaxation testing for viscoelastic materials
- Subsidence risk evaluation
- Device migration assessment
- Coating durability testing if applicable
Labelling
- Must include intended uses, device description, contraindications, precautions, warnings
- Surgical technique manual required with explantation and revision procedures
- Instructions affecting safety should be highlighted
- Informed consent documents required with specific risk disclosures
Biocompatibility
- Testing according to ISO 10993-1
- Additional animal studies may be needed for novel materials
- Polymer characterization required if applicable
- Extraction analysis required for materials with potential leachables
Safety
- Comprehensive risk analysis required
- Retrieval study plan recommended
- Adverse event monitoring and reporting procedures
- Safety endpoints include device migration, neurological status, complications
Other considerations
- Statistical analysis plan required
- Monitoring procedures must be defined
- Case Report Forms must capture all protocol requirements
- Shelf life evaluation for applicable devices
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Design Controls for Medical Device Manufacturers
- Testing of Non-Articulating, Mechanically Locked Modular Implant Components in Orthopedic Devices
- Testing Requirements for Orthopedic Implants with Modified Metallic Bone-Interface Surfaces
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
Related references and norms
- ASTM F2345-05: Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
- ASTM F2423: Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
- ASTM F561: Standard Practice for Retrieval and Analysis of Medical Devices
- ASTM F1877: Standard Practice for Characterization of Particles
- ISO 10993-1: Biological evaluation of medical devices
Original guidance
- Total Artificial Disc Devices - Pre-clinical Testing and Clinical Trial Design Requirements
- HTML / PDF
- Issue date: 2008-04-11
- Last changed date: 2020-03-20
- Status: FINAL
- Official FDA topics: Medical Devices, Investigational Device Exemption (IDE), Orthopedic, Premarket
- ReguVirta summary file ID: f5d2abe5941132e7246f9adf3ee60128
This post is licensed under CC BY 4.0 by the author.