Intervertebral total disc replacement (TOR) implants potentially herald a paradigm shift in the management of degenerative disc disease. Preservation of motion may avoid adjacent-segment degeneration, a well-recognized complication effusion. Based on encouraging experience in Europe and now-concluding IDE trials, FDA approval is likely in early/mid 2005 for two leading designs: Charite III and ProDisc. As an alternative to fusion (approximately 330,000/year in the U.S.), an onrush of implantations of these devices seems imminent. The potential for late wear-related complications is concerning. Both devices involve metal-on-conventional-polyethylene bearings, and the TDR patient population is a decade younger than for THR/TKR. Moreover, owing to close proximity of the spinal cord, the potential consequences of implant failure are much more dire than for THR/TKR. It is crucial that the scientific community expeditiously confront the issue of TDR wear. A Bioengineering Research Partnership is proposed to provide a firm scientific basis for identifying and dealing with wear-related problems in TDR.
Aim 1 is to develop techniques for TDR wear assessment in the pre-clinical phase. This will be done leveraging complementary numerical and physical techniques: sliding-distance-coupled finite element analysis (Iowa) and servo-controlled laboratory simulation (Leeds).
Aim 2 is to implement a novel approach to in vivo TDR radiographic wear measurement (Iowa), using high-resolution digital image analysis to assess relative three-dimensional pose position of the implant's metallic end plates. After documenting accuracy/precision, the pose image analysis technique will be used to measure wear in one of the largest/longest-ongoing European TDR series (Munich).
Aim 3 is to assess the functional biologic activity of TDR wear debris (Leeds). Morphologically realistic simulator-generated debris will be used to challenge cells in a culture preparation specifically tailored to reflect the local spinal environment, from which key metrics of the inflammatory/osteolytic cascade will be assayed.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Research Project (R01)
Project #
5R01AR052653-03
Application #
7241570
Study Section
Special Emphasis Panel (ZRG1-MOSS-G (52))
Program Officer
Panagis, James S
Project Start
2005-09-22
Project End
2010-06-30
Budget Start
2007-07-01
Budget End
2008-06-30
Support Year
3
Fiscal Year
2007
Total Cost
$494,656
Indirect Cost
Name
University of Iowa
Department
Orthopedics
Type
Schools of Medicine
DUNS #
062761671
City
Iowa City
State
IA
Country
United States
Zip Code
52242
Hyde, Philip J; Fisher, John; Hall, Richard M (2017) Wear characteristics of an unconstrained lumbar total disc replacement under a range of in vitro test conditions. J Biomed Mater Res B Appl Biomater 105:46-52
Hyde, P J; Tipper, J; Fisher, J et al. (2015) Wear and biological effects of a semi-constrained total disc replacement subject to modified ISO standard test conditions. J Mech Behav Biomed Mater 44:43-52
Papageorgiou, Iraklis; Marsh, Rainy; Tipper, Joanne L et al. (2014) Interaction of micron and nano-sized particles with cells of the dura mater. J Biomed Mater Res B Appl Biomater 102:1496-505
Behl, Bharat; Papageorgiou, Iraklis; Brown, Christopher et al. (2013) Biological effects of cobalt-chromium nanoparticles and ions on dural fibroblasts and dural epithelial cells. Biomaterials 34:3547-58
Vicars, Rachel; Prokopovich, Polina; Brown, Thomas D et al. (2012) The effect of anterior-posterior shear on the wear of CHARITÉ total disc replacement. Spine (Phila Pa 1976) 37:E528-34
Goreham-Voss, Curtis M; Hyde, Philip J; Hall, Richard M et al. (2010) Cross-shear implementation in sliding-distance-coupled finite element analysis of wear in metal-on-polyethylene total joint arthroplasty: intervertebral total disc replacement as an illustrative application. J Biomech 43:1674-81
Vicars, R; Hyde, P J; Brown, T D et al. (2010) The effect of anterior-posterior shear load on the wear of ProDisc-L TDR. Eur Spine J 19:1356-62
Vicars, R; Fisher, J; Hall, R M (2009) The accuracy and precision of a micro computer tomography volumetric measurement technique for the analysis of in-vitro tested total disc replacements. Proc Inst Mech Eng H 223:383-8