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Wear analysis of the Bryan Cervical Disc prosthesis.
Paul A Anderson1, Jeffrey P Rouleau, Vincent E Bryan
1University of Wisconsin, Department of Orthopedic Surgery and Rehabilitation, University of Wisconsin Hospitals, Madison, Wisconsin 53792, USA. anderson@surgery.wisc.edu
Spine
|October 16, 2003
Summary
The Bryan cervical disc shows good wear performance and minimal biologic response in simulated use and animal studies. This artificial disc replacement is a promising option for spinal fusion alternatives.
Area of Science:
- Biomedical Engineering
- Orthopedic Surgery
- Materials Science
Background:
- Arthroplasties often fail due to wear and subsequent inflammatory responses.
- Evaluating wear characteristics of spinal disc replacements is crucial for long-term success.
- The Bryan cervical disc is a novel implant requiring thorough wear and biologic assessment.
Purpose of the Study:
- To determine the wear characteristics of the Bryan cervical disc prosthesis.
- To assess the biologic response to wear debris in animal models.
Main Methods:
- In vitro wear testing using a cervical spine simulator under physiological loads and motions.
- Analysis of wear debris according to ASTM standards.
- Biologic response assessment in chimpanzee and goat models, including local and distant tissue evaluation.
Main Results:
- Wear particulate was generated at 1.2 mg/million cycles, with device height decreasing due to creep.
- Particles were granular (3.9 microm mean feret diameter).
- Animals tolerated the implant; wear debris was found locally but did not elicit a significant inflammatory response, with no distant tissue involvement.
Conclusions:
- The Bryan cervical disc demonstrates satisfactory wear characteristics.
- The implant does not induce a significant inflammatory response, suggesting a favorable safety profile.