Clinical StudyLong-term clinical results following Charite III lumbar total disc replacement
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
References (58)
- et al.
Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: five-year follow-up
Spine J
(2009) - et al.
Mid- to long-term results of total lumbar disc replacement: a prospective analysis with 5- to 10-year follow-up
Spine J
(2014) - et al.
Prosthetic total disk replacement—can we learn from total hip replacement?
Orthop Clin North Am
(2011) - et al.
Experimental measurements of vertebral motion under load
Orthop Clin North Am
(1977) Clinical results of Charité lumbar total disc replacement
Orthop Clin North Am
(2005)- et al.
Ten-year survival and clinical outcome of the AcroFlex lumbar disc replacement for the treatment of symptomatic disc degeneration
Spine J
(2013) - et al.
Adjacent segment stenosis after lumbar fusion requiring second operation
J Orthop Sci
(2005) - et al.
Incidence and prevalence of surgery at segments adjacent to a previous posterior lumbar arthrodesis
Spine J
(2011) The fate of the adjacent motion segments after lumbar fusion
J Spinal Disord Tech
(2003)- et al.
Long-term follow-up of functional outcomes and radiographic changes at adjacent levels following lumbar spine fusion for degenerative disc disease
Eur Spine J
(2001)
Accelerated degeneration of the segment adjacent to a lumbar fusion
Spine
Clinical and radiological outcomes with the Charité artificial disc: a 10-year minimum follow-up
J Spinal Disord Tech
Adjacent segment degeneration in the lumbar spine
J Bone Joint Surg Am
The impact of adjacent level disc degeneration on health status outcomes following lumbar fusion
Spine
The impact of adjacent segment degeneration on the clinical outcome after lumbar spinal fusion
Spine
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
Why a mechanical disc?
Spine J
Artificial disc: preliminary results of a prospective study in the United States
Eur Spine J
Lumbar total disc replacement for discogenic low back pain: two-year outcomes of the activeL multicenter randomized controlled IDE clinical trial
Spine
Lumbar disc arthroplasty with maverick disc versus stand-alone interbody fusion: a prospective, randomized, controlled, multicenter investigational device exemption trial
Spine
Five-year results of the prospective, randomized, multicenter, Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential arthrodesis for the treatment of single-level degenerative disc disease
J Neurosurg Spine
Optimizing success with lumbar disc arthroplasty
Eur Spine J
Retrospective study on effectiveness of Activ-L total disc replacement: clinical and radiographical results of 1- to 3-year follow-up
Spine
An 11-year minimum follow-up of the Charite III lumbar disc replacement for the treatment of symptomatic degenerative disc disease
Eur Spine J
Intervertebral disc arthroplasty
Spine
Prospective clinical and radiographic results of CHARITE III artificial total disc arthroplasty at 2- to 7-year follow-up: a Canadian experience
Can J Surg
Charite total disc replacement—clinical and radiographical results after an average follow-up of 17 years
Eur Spine J
Survival and clinical outcome of SB Charite III disc replacement for back pain
J Bone Joint Surg Br
Current trends in spinal arthroplasty: an assessment of surgeon practices and attitudes regarding cervical and lumbar disk replacement
Geology
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.