title: Development of a clinically relevant impingement test method for a mobile bearing lumbar total disc replacement.
abstract: Total disc arthroplasty is an alternative therapy to spinal fusion for the treatment of neck or low back pain and is hypothesized to reduce the risk of disease progression to the adjacent spinal levels. Radiographic and retrieval analyses of various total disc replacements (TDRs) have shown evidence of impingement damage. Impingement of TDRs can occur when the device reaches the limits of its functional range of motion, causing contact between peripheral regions of the device.
  
  
  
  Impingement can be associated with increased wear and mechanical damage; however, impingement conditions are not simulated in current standardized mechanical bench test methods. This study explored the test conditions necessary to apply clinically relevant impingement loading to a lumbar TDR in vitro.
  
  
  
  An experimental protocol was developed and evaluated using in vivo retrievals for qualitative and quantitative validation.
  
  
  
  Retrieval analysis was conducted on a set of 11 size 3 retrieved Charité devices using American Society for Testing and Materials F561 as a guide. The impingement range of motion was determined using a combination of modeling and experiments, and was used as an input in vitro testing. A 1-million cycle in vitro test was then conducted, and the in vitro samples were characterized using methods similar to the retreived devices.
  
  
  
  All in vitro tested samples exhibited impingement regions and damage patterns consistent with retrieved devices. Consistent with the retrievals, the impingement damage on the rim was a combination of abrasive wear and plastic deformation. Micro computed tomography (microCT) was used to quantitatively assess rim damage due to impingement. Rim penetration was statistically lower in the retrievals when compared with both in vitro groups. Rim elongation was comparable among all groups. The simulated-facet group had statistically greater angular rim deformations than the retrieval group and the no-facet group.
  
  
  
  Results demonstrate that clinically relevant impingement seen on mobile bearings of lumbar TDRs can be replicated on the bench.
authors.affiliation: Exponent, Inc., Philadelphia, PA, USA; Drexel University, Philadelphia, PA, USA. Electronic address: rsiskey@exponent.com.
authors.forename: Ryan
authors.initials: R
authors.lastname: Siskey
authors.affiliation: US Food and Drug Administration, White Oak, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Peck
authors.affiliation: US Food and Drug Administration, White Oak, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Hitesh
authors.initials: H
authors.lastname: Mehta
authors.affiliation: Exponent, Inc., Philadelphia, PA, USA; Drexel University, Philadelphia, PA, USA.
authors.forename: Allison
authors.initials: A
authors.lastname: Kosydar
authors.affiliation: Exponent, Inc., Philadelphia, PA, USA; Drexel University, Philadelphia, PA, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Kurtz
authors.affiliation: US Food and Drug Administration, White Oak, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Genevieve
authors.initials: G
authors.lastname: Hill
mesh_terms: D006801:Humans; D007403:Intervertebral Disc / Q000601:surgery; D008159:Lumbar Vertebrae / Q000601:surgery; D008422:Materials Testing / Q000379:methods*; D019736:Prostheses and Implants / Q000592:standards*; D011475:Prosthesis Failure; D016059:Range of Motion, Articular; D059145:Total Disc Replacement / Q000295:instrumentation* / Q000379:methods
keywords: Cobalt chrome; Explant analysis; Impingement; Retrieval analysis; Total disc arthroplasty; Total disc replacement; Ultra-high molecular weight polyethylene; Wear