Clinical Data Presentation for Orthopedic Implant Device Submissions

What You Need to Know? 👇

What are the key elements required for clinical data presentations in orthopedic device submissions?

FDA recommends including patient demographics, time course patient accounting, written adverse event descriptions, effectiveness parameters, and individual patient success rates. All data should clearly identify patient numbers evaluated at each timepoint and stratify by investigational/control groups.

How should adverse events be categorized and reported for orthopedic devices?

Adverse events should be organized into operative site-related and systemic events, categorized using WHO recommendations. Report all events regardless of occurrence rate, including anticipated and unanticipated complications, with detailed narratives describing demographics, subsequent interventions, and device associations.

What is the minimum follow-up rate required for IDE and PMA submissions?

FDA recommends maintaining at least 85% follow-up of patients in each study cohort to preserve study power, avoid bias, and provide sufficient data for analysis. If this goal isn’t met, provide adequate explanation and describe steps to achieve proper follow-up.

How are subsequent surgical interventions classified in orthopedic device studies?

FDA categorizes them as: revisions (adjusting/modifying original implant), removals (complete system removal), reoperations (procedures without component changes), supplemental fixations (additional instrumentation), and other interventions (seemingly unrelated surgeries). Each requires clear definitions and rationale for failure classification.

What constitutes “actual” versus “expected” patients in follow-up accounting?

“Actual” includes patients evaluated within protocol windows with complete endpoint data. “Expected” equals theoretical patients minus deaths and failures. The follow-up rate is calculated as Actual/Expected × 100, helping assess study compliance and data quality.

How should effectiveness data be presented for orthopedic clinical evaluations?

Present results in tabular format showing number of patients meeting each rating score (e.g., Harris Hip Score categories). Include separate tables for different patient groups and stratify by study parameters. Provide patient success results showing numbers meeting success criteria at each timepoint.

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What You Need to Do 👇

Recommended Actions

1. Develop standardized data collection forms aligned with recommended presentation formats
2. Implement clear protocols for:
   • Patient follow-up scheduling and windows
   • Adverse event categorization
   • Secondary surgical intervention definitions
   • Success/failure criteria
3. Establish processes to:
   • Track patient accounting and follow-up rates
   • Document complete assessment evaluations
   • Record and categorize all adverse events
   • Monitor protocol compliance
4. Create data presentation templates for:
   • Demographics and patient population description
   • Patient accounting
   • Safety outcomes (adverse events and surgical interventions)
   • Effectiveness parameters
   • Success rates
5. Plan for sensitivity analyses to address incomplete/out-of-window data
6. Maintain minimum 85% follow-up rate through proper patient tracking and retention strategies

Key Considerations

Clinical testing

• Minimum 85% follow-up of patients in each study cohort required
• Clear description of evaluation intervals pre- and post-treatment with defined follow-up windows
• Complete description of patient population including demographics and diagnoses
• Time course distribution of patient accounting and outcomes
• Sensitivity analysis for incomplete/out-of-window data

Safety

• Record and report all preoperative, operative, and postoperative complications
• Categorize adverse events as device-related, operative site-related, and systemic
• Report subsequent secondary surgical interventions separately
• Clearly identify which reasons for removal constitute a patient failure

Other considerations

• Present data stratified by investigational and control groups
• Separate presentations for patients implanted outside the study
• Provide clinical and statistical rationales for including protocol deviations
• Include all adverse events regardless of rate of occurrence

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Relevant Guidances 🔗

• Clinical Study Design Recommendations for Catheter Ablation Devices in Treatment of Type I Atrial Flutter
• Design Considerations for Medical Device Pivotal Clinical Studies
• Evaluation of Sex-Specific Data in Medical Device Clinical Studies
• Collection and Reporting of Race and Ethnicity Data in Clinical Trials

Related references and norms 📂

• WHO: International Classification Systems for categorizing adverse events

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Original guidance

• Clinical Data Presentation for Orthopedic Implant Device Submissions
• HTML / PDF
• Issue date: 2004-12-01
• Last changed date: 2025-01-31
• Status: FINAL
• Official FDA topics: Premarket, Medical Devices
• ReguVirta ID: 54ee0e8785f6bd18e624abb0a97ad2d4