Committee Accomplishments from October 31, 2002 to October 30, 2003

1. Prepared joint arthroplasty seminar for Food and Drug Administration (FDA) reviewers. Orthopaedic surgeons will discuss assessing outcomes and understanding the data, the impact of evolving technologies and techniques on device regulation, alternative bearing surfaces, biological concerns, and clinical assessment. Presented at FDA on January 23, 2004.
2. Provided a regulatory pathway for the first marketing clearance of an antibiotic bone cement preparation.
3. Facilitated a fellowship at the Centers for Devices and Radiological Health (CDRH)/FDA for a senior level spine expert.
4. Formed a biological issues subcommittee to address emerging trends in orthopaedics such as off-label use of bone morphogenetic proteins and osteoinductive testing of demineralized bone substitutes.
5. Published an American Academy of Orthopaedic Surgeons (AAOS) Bulletin article “Perspectives on Vertebral Augmentation: Kyphoplasty, Vertebroplasty, or ‘No-plasty’ ” in October 2002.
6. Reviewed and provided input on the Orthopaedic Surgical Manufacturers’ Association (OSMA) petition for the reclassification of mobile bearing knees.
7. Presented two symposia at the AAOS Annual Meeting 2003: “Musculoskeletal Allograft Tissue: Safety and Efficacy” and “Alternative Bearing Surfaces in Total Hip Replacement: What Do We Know in 2003?”
8. Presented three scientific exhibits at the AAOS Annual Meeting 2003: “Musculoskeletal Tissue Transplantation in Orthopaedic Surgery: Safety and Donation. What Makes Tissue Safe and Where Does it Come From?” in conjunction with the Patient Safety Committee and the American Association of Tissue Banks and “New Polys for Old: Contribution or Caveat?” Also, produced an exhibit on antibiotic bone cement issues in 2003.
9. Presented two ICLs at the AAOS Annual Meeting 2003: “Alternative Bearing Surfaces: The Good, Bad and Ugly,” and “Revision Total Knee Arthroplasty: Planning, Management, and Controversies.”
10. Drafted a guidance document to ensure a standardized method for designing the clinical trials intended to measure the safety and efficacy of hip replacement systems.

1. Present ICLs at the AAOS Annual Meeting 2004 on “Soft Tissue balancing of the Hip- A Concept which has Come of Age”, “Technology 2004: Alternative Bearing Surfaces: The Good, the Bad, & the Ugly” and “Current Concepts of Mobile Bearing Total Knee Arthroplasty.”
2. Produce a scientific exhibit on antibiotic bone cement for the AAOS Annual Meeting 2004.

1. Continue to facilitate coordination between the AAOS Committee on Biological Implants and the AAOS Committee on Biomedical Engineering as they address their specific issues and in their interactions with the FDA and the American Society for Testing and Materials (ASTM).
2. Continued involvement in rewriting revisions to the International Standard Organization (ISO) hip wear standard.
3. Orthopaedic Device Forum website maintained and updated after each meeting.
4. Continue to monitor and review federal legislation and regulatory policies on orthopaedic implants and biological issues.
5. Continued participation with standards organizations, ASTM and ISO.
6. Write an AAOS Bulletin article on antibiotic bone cement preparations.
7. Convene a subcommittee on antibiotic bone cement and provide input to the AAOS fellowship and scientific community on antibiotic resistance issues, strength and material characteristics.

1. Continue to explore opportunities for interaction among multiple federal agencies such as the FDA, the National Institutes of Health (NIH), and the Centers for Medicare and Medicaid Services (CMS) as appropriate to our activities/mission.
2. Development of educational initiatives for orthopaedic surgeons and health professionals to promote the delivery of high quality healthcare and reduce the regulatory burdens.