title: Reducing subsidence risk by using rapid manufactured patient-specific intervertebral disc implants.
abstract: BACKGROUND
  Intervertebral disc implant size, shape, and position during total disc replacement have been shown to affect the risk of implant subsidence or vertebral fracture. Rapid manufacturing has been successfully applied to produce patient-specific implants for craniomaxillofacial, dental, hip, and knee requirements, but very little has been published on its application for spinal implants.
  
  
  OBJECTIVE
  This research was undertaken to investigate the improved load distribution and stiffness that can be achieved when using implants with matching bone interface geometry as opposed to implants with flat end plate geometries.
  
  
  METHODS
  The study design comprises a biomechanical investigation and comparison of compressive loads applied to cadaveric vertebrae when using two different end plate designs.
  
  
  METHODS
  Four spines from male cadavers (ages 45-65 years, average 52 years), which had a total of n=88 vertebrae (C3-L5), were considered during this study. Bone mineral density scans on each spine revealed only one to be eligible for this study. Twenty remaining vertebrae (C3-L3) were potted and subjected to nondestructive compression tests followed by destructive compression tests. Custom-made nonfunctional implants were designed for this experiment. Ten implants were designed with matching end plate-to-bone interface geometry, whereas the other 10 were designed with flat end plates. Testing did not incorporate the use of a keel in either design type. I-Scan pressure sensors (Tekscan, Inc., MA, USA) were used during the nondestructive tests to assess the load distribution and percentage surface contact.
  
  
  RESULTS
  Average percent contact area measured during nondestructive tests was 45.27% and 10.49% for conformal and flat implants, respectively-a difference that is statistically significant (p<.001). A higher percent contact area was especially observed for cervical vertebrae because of their pronounced end plate concavity. During destructive compression tests, conformal implants achieved higher failure loads than flat implants. Conformal implants also performed significantly better when stiffness values were compared (p<.0001).
  
  
  CONCLUSIONS
  One of the main expected benefits from customizing the end plate geometry of disc implants is the reduced risk and potential for subsidence into the vertebral bone end plate. Subsidence depends in part on the stiffness of the implant-bone construct, and with a 137% increase in stiffness, the results of this study show that there are indeed significant potential benefits that can be achieved through the use of customization during the design and manufacture of intervertebral disc implants.
authors.affiliation: Department of Industrial Engineering, Stellenbosch University, Private Bag X1, Matieland 7602, South Africa. ndebeer@sun.ac.za
authors.forename: Neal
authors.initials: N
authors.lastname: de Beer
authors.forename: Cornie
authors.initials: C
authors.lastname: Scheffer
mesh_terms: D000368:Aged; D019643:Arthroplasty, Replacement / Q000295:instrumentation*; D001672:Biocompatible Materials; D002102:Cadaver; D019245:Compressive Strength; D017586:Diskectomy; D004548:Elasticity; D019544:Equipment Failure Analysis; D006801:Humans; D007403:Intervertebral Disc; D007595:Joint Prosthesis; D008297:Male; D008875:Middle Aged; D018583:Pliability; D057285:Precision Medicine; D011475:Prosthesis Failure; D012307:Risk Factors; D013314:Stress, Mechanical; D013997:Time Factors; D016474:Weight-Bearing
chemical_list: D001672:Biocompatible Materials