Elsevier

The Spine Journal

Volume 18, Issue 6, June 2018, Pages 917-925
The Spine Journal

Clinical Study
Long-term clinical results following Charite III lumbar total disc replacement

https://doi.org/10.1016/j.spinee.2017.08.252Get rights and content

Abstract

Background Context

Lumbar total disc replacement (TDR) operation represents an alternative to lumbar fusion for the treatment of symptomatic lumbar intervertebral disc degeneration and has gained increasing attention in recent years.

Purpose

This study aimed to assess clinical outcomes in a cohort of patients with TDR and the long-term survival rate of the prostheses.

Study Design

This is a retrospective, single-center clinical study.

Patient Sample

The sample comprised 30 patients, giving a total of 35 prostheses after an average follow-up (FU) of 15.2 years following TDR, which was performed for the treatment of lumbar degenerative disc disease.

Outcome Measures

Clinical evaluation included visual analog scale (VAS) and the Oswestry Disability Index (ODI). Radiological parameters of intervertebral disc height (IDH), range of motion (ROM), lumbar lordosis, lumbar scoliosis, and prosthesis position were evaluated in surgical and adjacent levels. Complications and re-operation rates were also assessed.

Methods

Clinical evaluation and radiological parameters were evaluated preoperatively and at final FU. All data were collected by members of our department, including research assistants and nurses who were not involved in the decision making of this study.

Results

Thirty of the 35 patients participated in the final FU. The cumulative survival rate of the prosthesis at a mean FU of 15.4 years was 100%. The clinical success rate was 93.3%. The VAS and ODI scores at final FU were significantly lower than preoperatively (p<.001). The average ROM of the operated and superior adjacent segment decreased significantly at the final FU, whereas the inferior adjacent segment was not affected. The IDH of all surgical and adjacent levels were well maintained at the final FU. Ten patients had a lumbar scoliosis >3° and the mean angle was 8.5°, of which 7 had left convex curvature. Three prostheses were offset more than 5 mm from the midline on the coronal plane. Four prostheses showed subsidence. Twenty-six operative segments and five adjacent segments showed heterotopic ossification. Two patients of the total 35-patient cohort underwent a secondary operation.

Conclusions

Satisfactory clinical results and good prosthesis survival can be achieved in the long term. Lumbar TDR surgeries also have the potential to reduce the incidence of adjacent segment disease.

Introduction

Lumbar fusion is currently considered the gold standard treatment for discogenic low back pain (LBP), spinal stenosis, degenerative scoliosis, and other diseases of the spine [1], [2], [3], [4]. However, adjacent segment degeneration after fusion can result from increased pressure and activity in the adjacent segments, soft tissue damage, and poor lumbar-sagittal alignment, as well as from natural factors that occur with age or aggravate degeneration. This may lead to the recurrence of symptoms, and a decline in physical activity can subsequently affect quality of life [5], [6], [7].

With the aim of preventing these fusion-related negative side effects, spinal non-fusion technologies such as lumbar total disc replacement (TDR) have been introduced and have provided physicians with a new solution, with TDR surgery performed on patients over the last three decades [8], [9], [10]. Several studies of randomized controlled clinical trials have indicated that TDR has a clinical benefit not inferior to traditional fusion surgery [11], [12], [13], [14].

Although the results from 2 to 5 years of short-term follow-up (FU) have been positive [11], [15], [16], [17], the conclusions drawn in medium- and long-term studies have been varied [4], [17], [18], [19], [20], [21], [22]. Siepe et al. [22], in their study of outcomes after TDR with a mean FU period of 7.4 years, concluded that results were highly satisfactory, with limited complication and revision rates. A report by Lemaire et al. [4] describing outcomes from lumbar TDR surgery after a mean FU period of 11.3 years showed similar positive results. However, Ross et al. [21] found that anticipated clinical and radiological outcomes were not reached after an FU period of 13 years. The work of Whang et al. [23] revealed that the mobility of the operative segment was not maintained for long after TDR, and long-term efficacy from the perspective of “motion preservation” remained controversial. To date, the number of long-term TDR FU studies published is deficient. Many clinicians remain cautious about TDR surgery, fearing aggravated outcomes as well as excessive late complications such as device failure and revision surgery [24], [25], [26].

The aims of this study were to assess clinical outcomes in a cohort of patients with TDR and the long-term survival rate of the prostheses.

Section snippets

Diagnosis and patient selection

We reviewed 35 patients with lumbar degenerative disc disease (DDD) treated with SB Charite III Artificial Disc (DePuy, Raynham, MA, USA) replacement in our hospital between March 1999 and March 2002. Preoperative diagnosis was based on clinical signs and symptoms. Standard anterioposterior, lateral, and functional flexion-extension radiographic images were taken of each patient, and magnetic resonance imaging (MRI) evaluation of the lumbar spine was performed. Discography was used to identify

Study population

Thirty-five patients received lumbar TDR surgery between March 1999 and March 2002. After an average FU of 15.2 years (range 14.4–17.4 years), 30 patients (FU rate 85.7%), comprising 16 men and 14 women with an average age of 59.4 years (range 48–70 years), returned to the hospital for evaluation of clinical and radiological outcomes (referred to hereafter as final FU). The demographic characteristics and radiological parameters that assessed surgery of these patients are shown in Table 1. In

Discussion

Lumbar TDR operation represents an alternative to lumbar fusion for the treatment of symptomatic lumbar intervertebral disc degeneration and has gained increasing attention in recent years. To assess the clinical value of TDR, long-term data accumulation and analysis is critical. This study is the longest FU study of the outcome of Charite III TDR surgery in the Chinese population.

The data presented in this study show satisfactory clinical outcomes during an FU period between 14.4 and 17.4

Conclusions

The data from our study demonstrated that satisfactory clinical results and good prosthesis survival can be achieved in the long term, when physicians have reliable surgical experience and select the cohort of patients according to strict guidelines. Good health education, advising caution with work activities after surgery, is also important for the prevention of severe postoperative complications. Previous studies have shown that TDR can achieve superior clinical outcomes in the short- and

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  • Cited by (0)

    FDA device/drug status: Approved (Charité Artificial Disc).

    Author disclosures: SL: Nothing to disclose. SS: Nothing to disclose. CK: Nothing to disclose. WS: Nothing to disclose. HH: Nothing to disclose. QW: Nothing to disclose. YH: Nothing to disclose.

    The authors declare that there was no proprietary or commercial interest involved in this article.

    Siyuan Sun, MD, and Chao Kong, MD, are the co-leading authors.

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