Article

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.

Texas Back Institute, 6020 West Parker Road, Suite 200, Plano, TX 75093, USA.
The spine journal: official journal of the North American Spine Society (Impact Factor: 2.9). 09/2009; 9(5):374-86. DOI: 10.1016/j.spinee.2008.08.007
Source: PubMed

ABSTRACT The CHARITE artificial disc, a lumbar spinal arthroplasty device, was approved by the United States Food and Drug Administration in 2004 based on two-year safety and effectiveness data from a multicenter, prospective, randomized investigational device exemption (IDE) study. No long-term, randomized, prospective study on the CHARITE disc or any other artificial disc has been published to date.
The purpose of this study was to compare the safety and effectiveness at the five-year follow-up time point of lumbar total disc replacement using the CHARITE artificial disc (DePuy Spine, Raynham, MA) with that of anterior lumbar interbody fusion (ALIF) with BAK cages and iliac crest autograft, for the treatment of single-level degenerative disc disease from L4 to S1, unresponsive to nonoperative treatment.
Randomized controlled trial-five-year follow-up.
Ninety CHARITE patients and 43 BAK patients.
Self-reported measures: visual analog scale (VAS); validated Oswestry disability index (ODI version 1.0); Short-Form 36 Questionnaire, and patient satisfaction. Physiologic measures: radiographic range of motion, disc height, and segmental translation. Functional measures: work status.
Of the 375 subjects enrolled in the CHARITE IDE trial, 277 were eligible for the five-year study and 160 patients thereof completed the five-year follow-up. The completers included 133 randomized patients. Overall success was defined as improvement> or =15 pts in ODI vs. baseline, no device failure, absence of major complications, and maintenance or improvement of neurological status. Additional clinical outcomes included an ODI questionnaire as well as VAS, SF-36, and patient satisfaction surveys. Work status was tracked for all patients. Safety assessments included occurrence and severity of adverse events and device failures. Radiographic analyses such as index- and adjacent-level range of motion, segmental translation, disc height, and longitudinal ossification were also carried out.
Overall success was 57.8% in the CHARITE group vs. 51.2% in the BAK group (Blackwelder's test: p=0.0359, Delta=0.10). In addition, mean changes from baseline for ODI (CHARITE: -24.0 pts vs. BAK: -27.5 pts), VAS pain scores (CHARITE: -38.7 vs. BAK: -40.0), and SF-36 questionnaires (SF-36 Physical Component Scores [PCS]: CHARITE: 12.6 pts vs. BAK: 12.3 pts) were similar across groups. In patient satisfaction surveys, 78% of CHARITE patients were satisfied vs. 72% of BAK patients. A total of 65.6% patients in the CHARITE group vs. 46.5% patients in the BAK group were employed full-time. This difference was statistically significant (p=0.0403). Long-term disability was recorded for 8.0% of CHARITE patients and 20.9% of BAK patients, a difference that was also statistically significant (p=0.0441). Additional index-level surgery was performed in 7.7% of CHARITE patients and 16.3% of BAK patients. Radiographic findings included operative and adjacent-level range of motion (ROM), intervertebral disc height and segmental translation. At the five-year follow-up, the mean ROM at the index level was 6.0 degrees for CHARITE patients and 1.0 degrees for BAK patients. Changes in disc height were also similar for both CHARITE and BAK patients (0.7 mm for both groups, p=0.9827). Segmental translation was 0.4 and 0.8mm in patients implanted with CHARITE at L4-L5 vs. L5-S1, respectively, and 0.1mm in BAK patients.
The results of this five-year, prospective, randomized multicenter study are consistent with the two-year reports of noninferiority of CHARITE artificial disc vs. ALIF with BAK and iliac crest autograft. No statistical differences were found in clinical outcomes between groups. In addition, CHARITE patients reached a statistically greater rate of part- and full-time employment and a statistically lower rate of long-term disability, compared with BAK patients. Radiographically, the ROMs at index- and adjacent levels were not statistically different from those observed at two-years postsurgery.

0 Bookmarks
 · 
158 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: Study Design. A prospective clinical data analysis. Objective. To determine the long-term clinical success of 2-level total disc replacement (TDR) in patients with degenerative disc disease. Summary of Background Data. Early successful clinical results of 2-level TDR have been reported. Few studies exist that have described this procedure's durability in the long term. Methods. Fifteen patients underwent 2-level lumbar TDR with the ProDisc-L as part of a randomized trial, 13 of whom were available for follow-up. The patients were assessed preoperatively and at 2 years, 5 years, and more than 9 years postoperatively using visual Oswestry Disability Index. At the last follow-up visit, 2 additional questions were asked: satisfaction with surgery and willingness to undergo the same treatment. Finally, clinical success was assessed using a previously described definition. Results. Mean follow-up time was 9.6 years (range, 9.2–10.3 yr). Postoperatively there was a significant improvement in Oswestry Disability Index score from baseline (70.0 vs. 15.7 at 2 yr, P = 0.002) that remained unchanged during the period of follow-up (19.8 at 5 yr, P = 0.003 and 12.9 at 9–10 yr, P = 0.002). Ninety-two percent of patients were “satisfied” or “somewhat satisfied” with treatment and the same number would undergo treatment again. Eighty-five percent of patients achieved clinical success. Conclusion. This prospective study demonstrates the durable clinical success of 2-level lumbar TDR as assessed at more than 9 years postoperatively. Level of Evidence: 4
    Spine 01/2014; 39(11):906-910. · 2.45 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The purpose of our study was to compare lumbar fusion and motion-preserving procedures to determine whether lumbar fusion may be associated with a higher prevalence of adjacent segment degeneration (ASDeg) or adjacent segment disease (ASDis). We performed a systematic review and meta-analysis for articles published up to July 2013. We included randomized controlled trials and cohort studies that reported ASDeg or ASDis after lumbar fusion compared with motion-preserving devices. Two authors independently extracted the articles and the predefined data. A total of 13 studies with 1,270 patients met our inclusion criteria and were included in the final analysis. Our analysis showed that the prevalence of ASDeg and ASDis, and adjacent segment reoperation rate in the fusion group were higher than those in the motion-preserving devices group (P < 0.0001, P = 0.0008, and P < 0.0001, respectively). The prevalence of ASDeg and reoperation rate in the motion-preserving devices group were significantly lower than that in the fusion group for both short- and long-term follow-up (P = 0.0008 and P = 0.001 at <5 years of follow-up; P = 0.003 and P = 0.001 at >5 years of follow-up). The current evidence suggests that lumbar fusion may result in a higher prevalence of adjacent segment degeneration or disease than motion-preserving procedures.
    European Journal of Orthopaedic Surgery & Traumatology 04/2014; · 0.18 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Adjacent segment disease (ASD) is a potential long-term risk after lumbar fusion. Its incidence has been evaluated in anterior and posterior lumbar interbody fusions, but few studies have focused on transforaminal lumbar interbody fusion (TLIF). Relative risk of ASD with open or minimally invasive (MI) TLIF is poorly understood. To report our experience with risk for ASD in patients receiving TLIF and test its association with surgical approach, we performed a retrospective cohort study based on medical record review at a single institution. Eligible patients were ⩾18years old at operation, underwent single-level TLIF during the period 2007-2008, and had at least 6months postoperative follow-up. Patients were categorized by surgical approach (open versus MI). Primary outcome of interest was development of symptomatic ASD, defined by (1) new back and/or leg pain, (2) imaging findings adjacent to original surgical level, and (3) decision to treat. A total of 68 patients (16 open, 52 MI) were included in the analysis. Groups had similar baseline characteristics, except the open group tended to be older (p=0.04). Seven (10%) patients developed ASD. Mean patient age was 62years and three were male. Three underwent open and four underwent MI TLIF. Risk of ASD did not differ significantly by surgical approach. The MI group showed a trend toward decreased risk of ASD compared to the open group, although it was not statistically significant. This suggests MI TLIF may be associated with decreased long-term morbidity compared to the open approach. Large prospective studies are needed to confirm these findings.
    Journal of Clinical Neuroscience 05/2014; · 1.32 Impact Factor

Full-text

Download
88 Downloads
Available from
Jun 4, 2014