A compliant-mechanism approach to achieving specific quality of motion in a lumbar total disc replacement

Background The current generation of total disc replacements achieves excellent short- and medium-term results by focusing on restoring the quantity of motion. Recent studies indicate that additional concerns (helical axes of motion, segmental torque-rotation behavior) may have important implications in the health of adjacent segments as well as the health of the surrounding tissue of the operative level. The objective of this article is to outline the development, validation, and biomechanical performance of a novel, compliant-mechanism total disc replacement that addresses these concerns by including them as essential design criteria. Methods Compliant-mechanism design techniques were used to design a total disc replacement capable of replicating the moment-rotation response and the location and path of the helical axis of motion. A prototype was evaluated with the use of bench-top testing and single-level cadaveric experiments in flexion-extension, lateral bending, and axial torsion. Results Bench-top testing confirmed that the moment-rotation response of the disc replacement matched the intended design behavior. Cadaveric testing confirmed that the moment-rotation and displacement response of the implanted segment mimicked those of the healthy spinal segment. Conclusions Incorporation of segmental quality of motion into the foundational stages of the design process resulted in a total disc replacement design that provides torque-rotation and helical axis–of–motion characteristics to the adjacent segments and the operative-level facets that are similar to those observed in healthy spinal segments.

[1]  Gun Choi,et al.  CHARITÉ Versus ProDisc: A Comparative Study of a Minimum 3-Year Follow-up , 2007, Spine.

[2]  ScienceDirect International journal of spine surgery , 2012 .

[3]  H. Tropp,et al.  Results from a randomized controlled study between total disc replacement and fusion compared with results from a spine register , 2010, SAS Journal.

[4]  Hendrik Schmidt,et al.  Interaction Between Finite Helical Axes and Facet Joint Forces Under Combined Loading , 2008, Spine.

[5]  Larry L. Howell,et al.  A Pseudo-Rigid-Body Model of the Human Spine to Predict Implant-Induced Changes on Motion , 2011 .

[6]  B. Freeman,et al.  Total disc replacement in the lumbar spine: a systematic review of the literature , 2006, European Spine Journal.

[7]  H. Serhan,et al.  Motion-preserving technologies for degenerative lumbar spine: The past, present, and future horizons , 2011, International Journal of Spine Surgery.

[8]  Jonathan B. Hopkins,et al.  Corrigendum to Synthesis of multi-degree of freedom, parallel flexure system concepts via Freedom and Constraint Topology (FACT)—Part I: Principles , 2010 .

[9]  Clément Gosselin,et al.  A Compliant Rolling Contact Joint and Its Application in a 3-DOF Planar Parallel Mechanism With Kinematic Analysis , 2004 .

[10]  I Söderkvist,et al.  Determining the movements of the skeleton using well-configured markers. , 1993, Journal of biomechanics.

[11]  P. Anderson,et al.  Quality of Spinal Motion With Cervical Disk Arthroplasty: Computer-aided Radiographic Analysis , 2010, Journal of spinal disorders & techniques.

[12]  Jonathan B. Hopkins,et al.  Synthesis of multi-degree of freedom, parallel flexure system concepts via freedom and constraint topology (FACT). Part II: Practice , 2010 .

[13]  S. Kurtz,et al.  Polyethylene wear and rim fracture in total disc arthroplasty. , 2007, The spine journal : official journal of the North American Spine Society.

[14]  D. Sengupta,et al.  Biomechanical Evaluation of the Kinematics of the Cadaver Lumbar Spine Following Disc Replacement With the Prodisc-L Prosthesis , 2010, Spine.

[15]  Avinash G Patwardhan,et al.  Response of Charité total disc replacement under physiologic loads: prosthesis component motion patterns. , 2005, The spine journal : official journal of the North American Spine Society.

[16]  F. Geisler,et al.  Prospective, Randomized, Multicenter FDA IDE Study of CHARITÉ Artificial Disc versus Lumbar Fusion: Effect at 5-year Follow-up of Prior Surgery and Prior Discectomy on Clinical Outcomes Following Lumbar Arthroplasty , 2009, SAS Journal.

[17]  S. Esterby American Society for Testing and Materials , 2006 .

[18]  T. Oxland,et al.  Neutral zone and range of motion in the spine are greater with stepwise loading than with a continuous loading protocol. An in vitro porcine investigation. , 2004, Journal of biomechanics.

[19]  S. Kurtz,et al.  Polyethylene Wear Debris and Long-term Clinical Failure of the Charité Disc Prosthesis: A Study of 4 Patients , 2007, Spine.

[20]  Larry L. Howell,et al.  Compliant high-precision E-quintet ratcheting (CHEQR) mechanism for safety and arming devices , 2007 .

[21]  Larry L. Howell,et al.  Ortho-planar linear-motion springs , 2001 .

[22]  Larry L. Howell,et al.  Compliant Rolling-Contact Element Mechanisms , 2005 .

[23]  H. Lee,et al.  Clinical Outcome of Lumbar Total Disc Replacement Using ProDisc-L in Degenerative Disc Disease: Minimum 5-Year Follow-up Results at a Single Institute , 2012, Spine.

[24]  Larry L. Howell,et al.  Concepts for Achieving Multi-Stability in Compliant Rolling-Contact Elements , 2007 .

[25]  A. Patwardhan,et al.  A follower load increases the load-carrying capacity of the lumbar spine in compression. , 1999, Spine.

[26]  G. K. Ananthasuresh,et al.  Designing compliant mechanisms , 1995 .

[27]  Ian A. F. Stokes,et al.  Mechanical Conditions That Accelerate Intervertebral Disc Degeneration: Overload Versus Immobilization , 2004, Spine.

[28]  S. Kurtz,et al.  Total Disc Replacement Positioning Affects Facet Contact Forces and Vertebral Body Strains , 2008, Spine.

[29]  M. Panjabi,et al.  Development of Stabilimax NZ From Biomechanical Principles , 2007, SAS Journal.

[30]  Larry L. Howell,et al.  Evaluation and Comparison of Alternative Compliant Overrunning Clutch Designs , 2002 .

[31]  Larry L. Howell,et al.  Tension-based multi-stable compliant rolling-contact elements , 2010 .

[32]  Larry L. Howell,et al.  A Flexure-Based Bi-Axial Contact-Aided Compliant Mechanism for Spinal Arthroplasty , 2008 .

[33]  L. Claes,et al.  Finite helical axes of motion are a useful tool to describe the three-dimensional in vitro kinematics of the intact, injured and stabilised spine , 2004, European Spine Journal.

[34]  Anton E Bowden,et al.  Quality of motion considerations in numerical analysis of motion restoring implants of the spine. , 2008, Clinical biomechanics.

[35]  S. Kurtz,et al.  Wear pattern observations from TDR retrievals using autoregistration of voxel data. , 2010, Journal of biomedical materials research. Part B, Applied biomaterials.

[36]  R. Ostelo,et al.  Total disc replacement surgery for symptomatic degenerative lumbar disc disease: a systematic review of the literature , 2010, European Spine Journal.