Top

European Spine Journal

Published in:

01-04-2015 | Original Article

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

Authors: Antoine G. Tohmeh, William D. Smith

Published in: European Spine Journal | Special Issue 3/2015

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.

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–E1107CrossRefPubMed

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

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 30:1565–1575CrossRefPubMed

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 93:705–715CrossRefPubMed

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–E1611CrossRefPubMed

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 32:1155–1162CrossRefPubMed

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

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

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 14:38–45CrossRefPubMed

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 6:435–443CrossRefPubMed

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

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

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

14.

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

15.

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

16.

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

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 31:1217–1226CrossRefPubMed

18.

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

19.

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

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 16:369–383CrossRefPubMed

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 44:1266–1272CrossRefPubMed

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 6:18–23CrossRefPubMedCentralPubMed

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–E129CrossRefPubMed

24.

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

25.

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

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 91:60–64PubMed

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 23:249–257CrossRefPubMed

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 18:353–359CrossRefPubMed

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 30:1576–1583CrossRefPubMed

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–S674CrossRefPubMed

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 16:411–421CrossRefPubMedCentralPubMed

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 14:466–469CrossRefPubMed

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 16:384–389CrossRefPubMed

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 89:82–88CrossRefPubMed

35.

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

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 1:143–154CrossRefPubMed

Title: 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
Authors: Antoine G. Tohmeh
William D. Smith
Publication date: 01-04-2015
Publisher: Springer Berlin Heidelberg
Published in: European Spine Journal / Issue Special Issue 3/2015
Print ISSN: 0940-6719
Electronic ISSN: 1432-0932
DOI: https://doi.org/10.1007/s00586-015-3843-z

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Purpose

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Special Issue 3/2015

Complications avoidance in extreme lateral interbody fusion (XLIF): video lecture

Visceral, vascular, and wound complications following over 13,000 lateral interbody fusions: a survey study and literature review

Less-invasive lateral lumbar interbody fusion (XLIF) surgical technique: video lecture

Clinical results and limitations of indirect decompression in spinal stenosis with laterally implanted interbody cages: results from a prospective cohort study

The learning curve of lateral access lumbar interbody fusion in an Asian population: a prospective study

Substantial clinical benefit of minimally invasive lateral interbody fusion for degenerative spondylolisthesis