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Lumbar total disc replacement by less invasive lateral approach: a report of results from two centers in the US IDE clinical trial of the XL TDR® device

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Abstract

Purpose

To evaluate the clinical and radiographic outcomes following total disc arthroplasty using the XL TDR® Lumbar Disc in the treatment of patients with symptomatic degenerative disc disease at one level between L1–2 and L4–5.

Methods

Data were compiled from two centers participating in a prospective, multi-center Food and Drug Administration-approved investigational device exemption clinical trial enrolling patients with single-level lumbar degenerative disc disease unresponsive to non-operative treatment. Longitudinal outcomes were evaluated through 3-year follow-up and included patient-reported pain, function, and general health, as well as radiographic measures such as maintenance of disc height and range of motion.

Results

The two-center cohort included 64 treated patients, 42 % female, averaging 45.3 years of age (range 26–67). The majority of procedures were performed at the L4–5 level (75 %), uncomplicated, with minimal blood loss (88 % 0–50 cc), and in an outpatient setting (93.8 %). Postoperative events included 10 patients (15.6 %) with new hip flexion weakness, 7 (10.9 %) with new lower extremity weakness, and 10 (15.6 %) with new lower extremity sensory deficits, all resolved by 3 months in all but two patients whose deficits were prolonged but eventually resolved. Average disc height increased postoperatively from 7.2 to 12.1 mm (69 %), and was 10.7 mm (49 % increase from preoperative) at 3 years. Flexion/extension range of motion averaged 5.9° (SD 4.8°) at 3 years, and was not statistically different from preoperative (p = 0.471). Heterotopic ossification interfering with segmental motion was noted in 3 patients (10.3 %) at 3 years, none ankylosed (Grade IV). Postoperative improvement in patient-reported outcomes was significant (p < 0.01 for all measures) and maintained through 3-year follow-up. Satisfaction with results was reported by 85 % (51/60) of patients at 2 years and 93 % (28/30) at 3 years. There were no revisions through 3 years postoperative.

Conclusions

The results following XL TDR show good clinical and radiographic outcomes out to 3 years postoperative, with clinically significant improvements in pain, function, and general health, few complications, and high patient satisfaction.

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References

  1. Boselie TF, Willems PC, van MH, de Bie RA, Benzel EC, van SH (2013) Arthroplasty versus fusion in single-level cervical degenerative disc disease: a Cochrane review. Spine 38:E1096–E1107

    Article  PubMed  Google Scholar 

  2. Jacobs WC, van der Gaag NA, Kruyt MC et al (2013) Total disc replacement for chronic discogenic low back pain: a Cochrane review. Spine 38:24–36

    Article  PubMed  Google Scholar 

  3. Blumenthal S, McAfee PC, Guyer RD et al (2005) A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes. Spine 30:1565–1575

    Article  PubMed  Google Scholar 

  4. Delamarter R, Zigler JE, Balderston RA, Cammisa FP, Goldstein JA, Spivak JM (2011) Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement compared with circumferential arthrodesis for the treatment of two-level lumbar degenerative disc disease: results at twenty-four months. J Bone Joint Surg Am 93:705–715

    Article  PubMed  Google Scholar 

  5. Gornet MF, Burkus JK, Dryer RF, Peloza JH (2011) Lumbar disc arthroplasty with MAVERICK disc versus stand-alone interbody fusion: a prospective, randomized, controlled, multicenter investigational device exemption trial. Spine 36:E1600–E1611

    Article  PubMed  Google Scholar 

  6. Zigler J, Delamarter R, Spivak JM et al (2007) Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease. Spine 32:1155–1162

    Article  PubMed  Google Scholar 

  7. Patel VC, Park DK, Herkowitz HN (2012) Lateral transpsoas fusion: indications and outcomes. ScientificWorldJournal 2012:893608

    Article  PubMed Central  PubMed  Google Scholar 

  8. Pimenta L, Diaz RC, Guerrero LG (2006) Charite lumbar artificial disc retrieval: use of a lateral minimally invasive technique. Technical note. J Neurosurg Spine 5:556–561

    Article  PubMed  Google Scholar 

  9. Pimenta L, Oliveira L, Schaffa T, Coutinho E, Marchi L (2011) Lumbar total disc replacement from an extreme lateral approach: clinical experience with a minimum of 2 years’ follow-up. J Neurosurg Spine 14:38–45

    Article  PubMed  Google Scholar 

  10. Ozgur BM, Aryan HE, Pimenta L, Taylor WR (2006) Extreme Lateral Interbody Fusion (XLIF): a novel surgical technique for anterior lumbar interbody fusion. Spine J 6:435–443

    Article  PubMed  Google Scholar 

  11. Peterson MD, Youssef JA (2013) Extreme Lateral Interbody Fusion (XLIF): Lumbar Surgical Technique. In: Goodrich J, Volcan I (eds) Extreme Lateral Interbody Fusion (XLIF), 2nd edn. QMP, St. Louis, pp 159–178

    Google Scholar 

  12. Cleaver N, Afshar H, Oliveira L et al (2013) Lateral Total Disc Replacement (XL TDR). In: Goodrich JA, Volcan IJ (eds) eXtreme Lateral Interbody Fusion (XLIF), 2nd edn. QMP, St. Louis, pp 341–353

    Google Scholar 

  13. Pimenta L, Schaffa TD, Lhamby JT et al (2008) Total Disc Replacement Through the XLIF Approach. In: Goodrich JA, Volcan IJ (eds) eXtreme Lateral Interbody Fusion (XLIF). QMP, St. Louis, pp 275–283

    Google Scholar 

  14. Murtagh R, Castellvi AE (2014) Motion preservation surgery in the spine. Neuroimaging Clin N Am 24:287–294

    Article  PubMed  Google Scholar 

  15. Bertagnoli R, Zigler J, Karg A, Voigt S (2005) Complications and strategies for revision surgery in total disc replacement. Orthop Clin North Am 36:389–395

    Article  PubMed  Google Scholar 

  16. Leary SP, Regan JJ, Lanman TH, Wagner WH (2007) Revision and explantation strategies involving the CHARITE lumbar artificial disc replacement. Spine 32:1001–1011

    Article  PubMed  Google Scholar 

  17. McAfee PC, Geisler FH, Saiedy SS et al (2006) Revisability of the CHARITE artificial disc replacement: analysis of 688 patients enrolled in the U.S. IDE study of the CHARITE Artificial Disc. Spine 31:1217–1226

    Article  PubMed  Google Scholar 

  18. Patel AA, Brodke DS, Pimenta L et al (2008) Revision strategies in lumbar total disc arthroplasty. Spine 33:1276–1283

    Article  PubMed  Google Scholar 

  19. Scott-Young M (2005) Strategy for revision disc replacement surgery. Roundtables in Spine Surgery 1:23–72

    Google Scholar 

  20. van Ooij A, Oner FC, Verbout AJ (2003) Complications of artificial disc replacement: a report of 27 patients with the SB Charite disc. J Spinal Disord Tech 16:369–383

    Article  PubMed  Google Scholar 

  21. Wagner WH, Regan JJ, Leary SP et al (2006) Access strategies for revision or explantation of the Charite lumbar artificial disc replacement. J Vasc Surg 44:1266–1272

    Article  PubMed  Google Scholar 

  22. Marchi L, Oliveira L, Coutinho E, Pimenta L (2012) The importance of the anterior longitudinal ligament in lumbar disc arthroplasty: 36-month follow-up experience in extreme lateral total disc replacement. Int J Spine Surg 6:18–23

    Article  PubMed Central  PubMed  Google Scholar 

  23. Dooris AP, Goel VK, Grosland NM, Gilbertson LG, Wilder DG (2001) Load-sharing between anterior and posterior elements in a lumbar motion segment implanted with an artificial disc. Spine 26:E122–E129

    Article  CAS  PubMed  Google Scholar 

  24. Rundell SA, Auerbach JD, Balderston RA, Kurtz SM (2008) Total disc replacement positioning affects facet contact forces and vertebral body strains. Spine 33:2510–2517

    Article  PubMed  Google Scholar 

  25. White A, Panjabi M (2001) Clinical Biomechanics of the Spine, 2nd edn. JB Lippincott, Philadelphia

    Google Scholar 

  26. Rajaraman V, Vingan R, Roth P, Heary RF, Conklin L, Jacobs GB (1999) Visceral and vascular complications resulting from anterior lumbar interbody fusion. J Neurosurg 91:60–64

    CAS  PubMed  Google Scholar 

  27. Le Huec JC, Lafage V, Bonnet X et al (2010) Validated finite element analysis of the maverick total disc prosthesis. J Spinal Disord Tech 23:249–257

    Article  PubMed  Google Scholar 

  28. Lemaire JP, Carrier H, Sariali E, Skalli W, Lavaste F (2005) Clinical and radiological outcomes with the Charite artificial disc: a 10-year minimum follow-up. J Spinal Disord Tech 18:353–359

    Article  PubMed  Google Scholar 

  29. McAfee PC, Cunningham B, Holsapple G et al (2005) A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes. Spine 30:1576–1583

    Article  PubMed  Google Scholar 

  30. Schmidt H, Galbusera F, Rohlmann A, Zander T, Wilke HJ (2012) Effect of multilevel lumbar disc arthroplasty on spine kinematics and facet joint loads in flexion and extension: a finite element analysis. Eur Spine J 21(Suppl 5):S663–S674

    Article  PubMed  Google Scholar 

  31. Tournier C, Aunoble S, Le Huec JC et al (2007) Total disc arthroplasty: consequences for sagittal balance and lumbar spine movement. Eur Spine J 16:411–421

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  32. Cheng WK, Jadhav V, Palmer DK (2011) A novel modification for removal of the polyethylene core in artificial disc retrieval using a transpsoas minimally invasive technique. J Neurosurg Spine 14:466–469

    Article  PubMed  Google Scholar 

  33. McAfee PC, Cunningham BW, Devine J, Williams E, Yu-Yahiro J (2003) Classification of heterotopic ossification (HO) in artificial disk replacement. J Spinal Disord Tech 16:384–389

    Article  PubMed  Google Scholar 

  34. Tortolani PJ, Cunningham BW, Eng M, McAfee PC, Holsapple GA, Adams KA (2007) Prevalence of heterotopic ossification following total disc replacement. A prospective, randomized study of two hundred and seventy-six patients. J Bone Joint Surg Am 89:82–88

    Article  PubMed  Google Scholar 

  35. Tohmeh AG, Rodgers WB, Peterson MD (2011) Dynamically evoked, discrete-threshold electromyography in the extreme lateral interbody fusion approach. J Neurosurg Spine 14:31–37

    Article  PubMed  Google Scholar 

  36. Geisler FH, Blumenthal SL, Guyer RD et al (2004) Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charite intervertebral disc. Invited submission from the joint section meeting on disorders of the spine and peripheral nerves, March 2004. J Neurosurg Spine 1:143–154

    Article  PubMed  Google Scholar 

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Acknowledgments

The XL TDR US IDE clinical trial was funded by NuVasive, Inc. The authors would like to acknowledge NuVasive Clinical Affairs and Clinical Resources for their operational and administrative support of the XL TDR IDE trial and data.

Conflict of interest

Antoine Tohmeh and William Smith are both consultants of NuVasive, Inc.

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Authors and Affiliations

  1. Northwest Orthopaedic Specialists, 212 East Central, Suite 140, Spokane, WA, 99208, USA

    Antoine G. Tohmeh

  2. Western Regional Center for Brain and Spine Surgery, Las Vegas, NV, USA

    William D. Smith

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  1. Antoine G. Tohmeh
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  2. William D. Smith
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Correspondence to Antoine G. Tohmeh.

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Tohmeh, A.G., Smith, W.D. Lumbar total disc replacement by less invasive lateral approach: a report of results from two centers in the US IDE clinical trial of the XL TDR® device. Eur Spine J 24 (Suppl 3), 331–338 (2015). https://doi.org/10.1007/s00586-015-3843-z

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  • DOI: https://doi.org/10.1007/s00586-015-3843-z

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