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Research ArticleLumbar Spine

Final Long-Term Reporting from a Randomized Controlled IDE Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease: 7-Year Results

Kris Radcliff, Jack Zigler, Ernest Braxton, Glen Buttermann, Dom Coric, Peter Derman, Rolando Garcia, Anton Jorgensen, Nicole C. Ferko, Aaron Situ and James Yue
International Journal of Spine Surgery July 2021, 8083; DOI: https://doi.org/10.14444/8083
Kris Radcliff
1Rothman Orthopedic Institute, Philadelphia, Pennsylvania
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Jack Zigler
2Texas Back Institute, Plano, Texas
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Ernest Braxton
3Vail Health Vail Summit Orthopaedics and Neurosurgery, Vail, Colorado
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Glen Buttermann
4Midwest Spine & Brain Institute, Stillwater, Minnesota
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Dom Coric
5Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina
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Peter Derman
2Texas Back Institute, Plano, Texas
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Rolando Garcia
6Orthopedic Care Center, Aventura, Florida
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Anton Jorgensen
7Ortho San Antonio, San Antonio, Texas
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Nicole C. Ferko
8CRG-EVERSANA Canada, Inc, Burlington, Ontario, Canada
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Aaron Situ
8CRG-EVERSANA Canada, Inc, Burlington, Ontario, Canada
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James Yue
9Frank H. Netter School of Medicine, Quinnipiac University, Hamden, Connecticut
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ABSTRACT

Background This study compared 7-year safety and efficacy outcomes of activL and ProDisc-L lumbar total disc replacements in patients with symptomatic, single-level lumbar degenerative disc disease (DDD). The objectives are to report 7-year outcomes of the trial, evaluate the outcomes for patients lost to follow-up, and determine whether early outcomes predict long-term outcomes.

Methods This was a prospective, multicenter, randomized, controlled investigational device exemption study. Eligible patients with symptomatic, single-level lumbar DDD had failed ≥6 months of nonsurgical management. Patients (N = 283) were randomized to receive activL (n = 218) or ProDisc-L (n = 65). At 7 years, data were available from 206 patients (activL, 160; ProDisc-L, 46). Logistic regression models were fit to predict 7-year outcomes for patients lost to follow-up after 2 years.

Results At 7 years, the activL group was noninferior to the ProDisc-L group on the primary composite endpoint (P = .0369). Both groups showed significant reductions in back/leg pain severity and improvements in disability index and quality-of-life relative to baseline (P < .0001). In both groups, opioid use was significantly reduced at 7 years (0%) relative to baseline (P < .01), and the overall reoperation rates were low (4.6%). activL patients showed a significantly better range of motion (ROM) for flexion-extension rotation than ProDisc-L patients (P = .0334). A significantly higher proportion of activL patients did not report serious adverse events (activL, 62%; ProDisc-L, 43%; P = .011). Predictive modeling indicated that >70% of patients (depending on outcome) lost to follow-up after 2 years would show clinically significant improvement at 7 years if improvements were achieved at 2 years.

Conclusions The benefits of activL and ProDisc-L are maintained after 7 years, with significant improvements from baseline observed in pain, function, and opioid use. activL is more effective at preserving ROM than ProDisc-L and has a more favorable safety profile. Improvements in other primary and secondary outcomes were similar between both disc designs.

Level of Evidence 1.

  • activL
  • artificial disc
  • back pain
  • degenerative disc disease
  • motion preservation
  • total disc replacement

Footnotes

  • Disclosures and COI: The devices that are the subject of this article were evaluated as part of a US Food and Drug Administration–approved investigational protocol (investigational device exemption) or corresponding national protocol for the treatment of single-level degenerative disc disease of the lumbar spine (L4 to S1) in patients who have been unresponsive to at least 6 months of prior conservative care. Aesculap Implant Systems, LLC (Center Valley, PA, USA), grant funds were received in support of this work. Aesculap Implant Systems, LLC, was involved in the study design and conduct, management of data, and manuscript approval. Relevant financial activities outside the submitted work include board membership, consultancy, expert testimony, payment for lectures, patents, royalties, stocks, and payment for development of educational presentations, travel, accommodations, or meeting expenses.

  • This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2021 ISASS
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International Journal of Spine Surgery
Vol. 17, Issue 1
1 Feb 2023
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Final Long-Term Reporting from a Randomized Controlled IDE Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease: 7-Year Results
Kris Radcliff, Jack Zigler, Ernest Braxton, Glen Buttermann, Dom Coric, Peter Derman, Rolando Garcia, Anton Jorgensen, Nicole C. Ferko, Aaron Situ, James Yue
International Journal of Spine Surgery Jul 2021, 8083; DOI: 10.14444/8083

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Final Long-Term Reporting from a Randomized Controlled IDE Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease: 7-Year Results
Kris Radcliff, Jack Zigler, Ernest Braxton, Glen Buttermann, Dom Coric, Peter Derman, Rolando Garcia, Anton Jorgensen, Nicole C. Ferko, Aaron Situ, James Yue
International Journal of Spine Surgery Jul 2021, 8083; DOI: 10.14444/8083
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Keywords

  • activL
  • artificial disc
  • back pain
  • degenerative disc disease
  • motion preservation
  • total disc replacement

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