Evolution of Lumbar Disc Replacement in the United States

Lumbar disc replacement (LDR) continues to gain popularity as a promising motion-preserving surgical treatment option for degenerative disc disease (DDD). While lumbar fusion remains the most common surgical technique used in the treatment of DDD, its limitations—such as adjacent segment degeneration and reduced spinal mobility—have driven interest in motion-preserving technologies. The first LDR device, the Charité artificial disc, was developed in Europe in the early 1980s and gained popularity there in the 1990s. Following its success in the European market, the implant then became the first LDR device to be introduced in the United States, receiving approval by the US Food and Drug Administration (FDA) in 2004. Despite favorable clinical data demonstrated in multiple large FDA trials, adoption of the technique has stagnated.1 A combination of adverse events and the litigation environment in the US during the early years of Charité negatively impacted the public and surgeon perception of the technology in the US. 2 The Charité implant was subsequently taken off of the market in 2012. Debate still exists among experts today whether the decline of that implant was truly related to adverse clinical outcomes stemming from design flaws versus the combination of a hostile medicolegal environment and strategic business decisions made by the manufacturer.3

Subsequent generation implants with more constrained bearing designs (ProDisc–L, Centinel; activL, Aesculap) were introduced in the United States in 2006 and 2015. Despite the proliferation of many different LDR designs in Europe, ProDisc-L and activL remained the only implants available in the US following the discontinuation of Charité. In 2024, Aesculap suspended US sales of its spine portfolio indefinitely, making ProDisc-L the only commercially available implant in the US at this time.

The limited adoption of LDR is difficult to reconcile with the favorable outcomes demonstrated in studies of long-term follow-up published during the past 5 years. Wen et al recently published a systematic review of 22 studies involving 2284 patients with an average follow-up of 8.3 years. TDR was found to significantly reduce pain, as evidenced by improvements in the visual analog scale and Oswestry Disability Index (ODI), with mean reductions of 51 and 30 points, respectively. Clinical success and patient satisfaction rates were high, averaging 74.8% and 86.3%, respectively.4 Complications such as implant subsidence, adjacent segment degeneration, and reoperation were noted, with a mean reoperation rate of 13.6%. No significant differences were observed between midterm (5 years) and long-term (10 years or more) outcomes.

Follow-up data on LDR patients more than 10 years after surgery were recently published with similarly favorable results.5 This study included 1187 patients who received 1- and 2-level procedures with ProDisc-L with an average follow-up duration of 11 years and 8 months. The authors reported a 50% to 60% reduction in ODI and pain scores with an exceptionally low rate of reoperation (4%). Subgroup analyses comparing patients with 1-level and 2-level surgery with and without a history of prior discectomy revealed no significant differences in outcomes or reoperation between groups.

The longest reported follow-up data LDR was published in 2022. The study had an average follow-up of 17 years in 16 patients from a Workers’ Compensation cohort.6 Despite the challenges related to the patient population, authors reported a 6.4-point reduction in pain scores at the 17-year follow-up, with 94% of patients reporting they would choose to undergo the surgery again in similar circumstances.

As with any procedure in spine surgery, patient selection plays an important role in the success of LDR. Difficulty in identifying appropriate candidates for the procedure is often cited as an obstacle to widespread adoption.7 It is important to note that the vast majority of prospective studies on LDR had strict inclusion criteria related to patient age, disc height, presence of deformity or spondylolisthesis, and pain distribution. The prototypical candidate for LDR is a young patient with axial low back pain who has imaging findings of isolated 1- or 2-level disc degeneration with preserved disc height and without a history of prior surgery at the level of concern. Patients with significant stenosis, spinal deformity, or spondylolisthesis are not typically considered for the procedure because such populations were not studied in FDA trials. Similarly, patients with a history of fusion at an adjacent segment have historically not been considered for LDR. Although LDR is yet to be widely adopted in the US, surgeons who are experienced with the technique continue to explore its applications beyond these traditional indications.

Cuellar et al studied the impact of anterior lumbar interbody fusion (ALIF) at L5-S1 when performed in conjunction with disc replacement at the adjacent levels. 8 The authors studied 46 patients receiving an L5-S1 ALIF simultaneously with 1, 2, or 3 LDRs at the adjacent levels. While the study did not have an ALIF-only control arm, the authors described a significant reduction in ODI and pain scores without any differences between groups with 1, 2, or 3 adjacent levels of disc replacement.

The appropriateness of LDR for persistent discogenic pain following microdiscectomy has also been debated due to the potentially destabilizing nature of laminotomy and partial facetectomy. Leahy et al evaluated this topic in a 2008 subgroup analysis of the Prodisc-L investigational device exemption trial, comparing outcomes for patients with and without a history prior discectomy.9 Patients in both cohorts improved significantly with regard to pain and disability following surgery. More than 80% of patients stated they would choose to undergo the procedure if faced with a similar circumstance again. The authors found no significant differences in outcomes between the cohorts and concluded that LDR was a viable treatment for patients with disc degeneration in the setting of prior discectomy.

Historically, patients with severe disc space collapse have not been thought to be appropriate for LDR due to concerns regarding subsidence and/or compromised segmental motion from “overstuffing.” Debate exists around how much preoperative disc height loss is acceptable in patients undergoing the procedure. Yaszay et al studied the impact of pre and postoperative disc height on clinical and radiographic outcomes following LDR.10 While no differences in clinical outcomes were observed based on the degree of disc height loss, the authors did find greater improvements in segmental range of motion in those with preoperative disc heights less than 9 mm. These findings would suggest that severe disc space collapse should not be considered a contraindication to LDR, more prospective data are needed.

Despite recent publications of favorable long-term clinical data and a track record spanning decades, adoption of LDR among US spine surgeons remains low. The significant body of literature around this technique deserves further attention from all spine surgeons interested in motion preservation, particularly those leading academic training programs. Surgeons experienced with LDR may be able to apply the technique to a wider variety of pathology than previously represented in industry device trials; however, further study in this area is needed. Diagnostic acumen and patient selection continue to be essential for the success of LDR even as our understanding of these topics continues to evolve.

References

1. Mills ES, Shelby T, Bouz GJ, et al. A decreasing national trend in lumbar disc arthroplasty. Global Spine J. 2023;13:2271–2277.

2. Sandhu FA, Dowlati E, Garica R. Lumbar arthroplasty: past, present, and future. Neurosurgery. 2020;86:155–69.

3. Guyer RD, Shellock J, Blumenthal SL, et al. What happened to patients who received the Charite lumbar artificial disc? [abstract P77]. Spine J. 2022;22:S163.

4. Wen DJ, Tavakoli J, Tipper JL. Lumbar total disc replacements for degenerative disc disease: a systematic review of outcomes with a minimum of 5 years follow-up. Global Spine J. 2024;14:1827–1837.

5. Marnay TP, Geneste GY, Edgard-Rosa GW, et al. Clinical outcomes after 1 and 2-level lumbar total disc arthroplasty: 1,187 patients with 7 to 21-year follow-up. J Bone Joint Surg Am. 2024;107:53.

6. Carlson J, Giblin M. Long-term results of Charité lumbar disc replacement: a 17-year follow-up in a workers’ compensation cohort. Int J Spine Surg. 2022;16:831–836.

7. Salzmann SN, Plais N, Shue J, et al. Lumbar disc replacement surgery—successes and obstacles to widespread adoption. Curr Rev Musculoskelet Med. 2017;10:153.

8. Cuellar JM, Rasouli A, Lanman TH, et al. Single and multilevel lumbar total disc replacement adjacent to L5-S1 ALIF (lumbar hybrid): 6 years of follow-up. Int J Spine Surg. 2021;15:971–977.

9. Leahy M, Zigler JE, Ohnmeiss DD, et al. Comparison of results of total disc replacement in postdiscectomy patients versus patients with no previous lumbar surgery. Spine (Phila Pa 1976). 2008;33:1690–1693.

10. Yaszay B, Bendo JA, Goldstein JA, et al. Effect of intervertebral disc height on postoperative motion and outcomes after ProDisc-L lumbar disc replacement. Spine (Phila Pa 1976). 2008;33:508–512.

Contributors:

Brandon P. Hirsch, MD

From DISC Sports and Spine Center in Newport Beach, California.