Clinical Studies for Vertebral Body Augmentation Devices in Treatment of Insufficiency Fractures
This guidance provides information regarding clinical studies for devices used in spinal vertebral body augmentation to treat insufficiency fractures due to minor trauma, osteoporosis, or other lytic conditions. It covers both vertebroplasty and kyphoplasty procedures using PMMA bone cements and potential future materials like resorbable and permanent polymers.
Recommended Actions
- Develop comprehensive clinical study protocol with defined inclusion/exclusion criteria
- Establish clear primary and secondary effectiveness parameters
- Implement robust safety monitoring system
- Create detailed risk analysis addressing all potential complications
- Develop comprehensive study monitoring plan
- Consider pre-submission meeting with FDA
- Ensure compliance with design control requirements
- Establish clear patient and study success criteria
- Plan for 2-year follow-up with regular evaluations
- Prepare well-organized submission addressing all special controls
Key Considerations
Clinical testing
- 2-year follow-up study recommended
- Regular interval evaluations with defined windows
- Concurrent randomized control recommended
- Success criteria based on:
- Pain and function improvement
- No secondary interventions
- Comparison to control group
- Inclusion/exclusion criteria must be clearly defined
Human Factors
- Assessment of pain and function using validated scales
- Evaluation of ambulatory status
- Quality of life measurements using validated scales
Safety
- Report all complications (device-related or not)
- Monitor for:
- Infections
- Secondary surgical interventions
- Neurological complications
- Serious adverse events
- Death
- Radiographic evaluations for:
- Material extravasation
- Adjacent fractures
- Osteolysis
- Material fracture
- Disease progression
Other considerations
- Comprehensive monitoring plan required
- Risk analysis must address all potential complications
- Pre-submission meeting with FDA recommended
- Well-organized submissions addressing special controls needed
Relevant Guidances
- Format for Clinical Data Presentations in Orthopedic Implant Device Submissions
- Design Considerations for Medical Device Pivotal Clinical Studies
- Benefit-Risk Determinations for Medical Device Premarket Review
- Use of Real-World Data to Generate Evidence for Medical Device Regulatory Decisions
Related references and norms
- 21 CFR 888.3027: Classification regulation for PMMA bone cement
- 21 CFR 812.3(d): Definition of permanent implants
- 21 CFR 820.30(g): Design control requirements for risk analysis
Original guidance
- Clinical Studies for Vertebral Body Augmentation Devices in Treatment of Insufficiency Fractures
- HTML
- Issue date: 2004-10-23
- Last changed date: 2020-03-19
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket
- ReguVirta summary file ID: 145fc40721ee0cdc84b40bee42fe3b35
This post is licensed under CC BY 4.0 by the author.