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. 2021 Aug;15(4):612-632.
doi: 10.14444/8083. Epub 2021 Jul 15.

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  1 , Jack Zigler  2 , Ernest Braxton  3 , Glen Buttermann  4 , Dom Coric  5 , Peter Derman  2 , Rolando Garcia  6 , Anton Jorgensen  7 , Nicole C Ferko  8 , Aaron Situ  8 , James Yue  9
Affiliations

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 et al. Int J Spine Surg. 2021 Aug.

Erratum in

  • Corrections.
    [No authors listed] [No authors listed] Int J Spine Surg. 2023 Oct;17(5):753. doi: 10.14444/8083cxx. Epub 2023 Sep 14. Int J Spine Surg. 2023. PMID: 37709543 Free PMC article. No abstract available.

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.

Keywords: activL; artificial disc; back pain; degenerative disc disease; motion preservation; total disc replacement.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
CONSORT flow diagram, activL versus ProDisc-L.
Figure 2
Figure 2
Radiographs of total disc replacement implants. (A) Anteroposterior view of activL, (B) lateral view of activL, (C) anteroposterior view of ProDisc-L, and (D) lateral view of ProDisc-L.
Figure 3
Figure 3
Oswestry Disability Index (ODI) through 7 years after treatment for activL versus ProDisc-L artificial discs. Multiple imputation was used for missing patient data. Values are presented as mean ± 95% confidence interval.
Figure 4
Figure 4
Visual analog scale (VAS) back and leg score through 7 years after treatment for activL versus ProDisc-L artificial discs. Multiple imputation was used for missing patient data. Values are presented as mean ± 95% confidence interval.
Figure 5
Figure 5
Thirty-six-item short form survey (SF-36), Mental Component Summary (MCS), and Physical Component Summary (PCS) data through 7 years after treatment for activL versus ProDisc-L artificial discs. Multiple imputation was used for missing patient data. Values are presented as mean ± 95% confidence interval.
Figure 6
Figure 6
Time to return to work through 7 years for activL versus ProDisc-L artificial discs. Kaplan-Meier estimate is 82% with activL and 74% with ProDisc-L. Log-rank P value = .34.
Figure 7
Figure 7
Freedom from serious adverse events through 7 years for activL versus ProDisc-L artificial discs. Kaplan-Meier estimate is 61.5% with activL and 43.1% with ProDisc-L. Log-rank P value = .011.
Figure 8
Figure 8
Opioid usage through 7 years after treatment for activL versus ProDisc-L artificial discs. At each follow-up time point postoperation, a significantly lower proportion of patients with activL and ProDisc-L total disc replacement (TDR) devices used opioids than at baseline (P < .01 at each time point). Multiple imputation was used for missing patient data.
Figure 9
Figure 9
Percentage of patients who achieved clinically significant improvement (CSI) at 7 years, stratified by their CSI status from predictor analysis for activL versus ProDisc-L artificial discs. Complete case analysis conducted (no imputations).
Figure A1
Figure A1
Oswestry Disability Index (ODI) through 7 years after treatment for activL versus control (ProDisc-L + Charité). Multiple imputation was used for missing patient data. Values are presented as mean ± 95% confidence interval.
Figure A2
Figure A2
Visual analog scale (VAS) back and leg score through 7 years after treatment for activL versus control (ProDisc-L + Charité). Multiple imputation was used for missing patient data. Values are presented as mean ± 95% confidence interval.
Figure A3
Figure A3
Thirty-six-item short form survey (SF-36), mental component summary (MCS), and physical component summary (PCS) through 7 years after treatment for activL versus control (ProDisc-L + Charité). Multiple imputation was used for missing patient data. Values are presented as mean ± 95% confidence interval.
Figure A4
Figure A4
Time to return to work through 7 years for activL versus control (ProDisc-L + Charité). Kaplan-Meier estimate is 82% with activL and 74% with control. Log-rank P value = .069.
Figure A5
Figure A5
Freedom from serious adverse events through 7 years for activL versus control (ProDisc-L + Charité). Kaplan-Meier estimate is 61.5% with activL and 44.3% with control. Log-rank P value = .0024.
Figure A6
Figure A6
CONSORT 2010 flow diagram.
See this image and copyright information in PMC

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