Prospective randomized study of the Charité artificial disc: data from two investigational centers (original) (raw)
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Spine, 2005
A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial. The purpose of this study was to compare the safety and effectiveness of lumbar total disc replacement, using the CHARITE artificial disc (DePuy Spine, Raynham, MA), with anterior lumbar interbody fusion, for the treatment of single-level degenerative disc disease from L4-S1 unresponsive to nonoperative treatment. Reported results of lumbar total disc replacement have been favorable, but studies have been limited to retrospective case series and/or small sample sizes. Three hundred four (304) patients were enrolled in the study at 14 centers across the United States and randomized in a 2:1 ratio to treatment with the CHARITE artificial disc or the control group, instrumented anterior lumbar interbody fusion. Data were collected pre- and perioperatively at 6 weeks and at 3, 6, 12, and 24 months following surgery. The key clinical outcome measures were a Visual Analog Scale assessing back pain, the Oswestry Disability Index questionnaire, and the SF-36 Health Survey. Patients in both groups improved significantly following surgery. Patients in the CHARITE artificial disc group recovered faster than patients in the control group. Patients in the CHARITE artificial disc group had lower levels of disability at every time interval from 6 weeks to 24 months, compared with the control group, with statistically lower pain and disability scores at all but the 24 month follow-up (P < 0.05). At the 24-month follow-up period, a significantly greater percentage of patients in the CHARITE artificial disc group expressed satisfaction with their treatment and would have the same treatment again, compared with the fusion group (P < 0.05). The hospital stay was significantly shorter in the CHARITE artificial disc group (P < 0.05). The complication rate was similar between both groups. This prospective, randomized, multicenter study demonstrated that quantitative clinical outcome measures following lumbar total disc replacement with the CHARITE artificial disc are at least equivalent to clinical outcomes with anterior lumbar interbody fusion. These results support earlier reports in the literature that total disc replacement with the CHARITE artificial disc is a safe and effective alternative to fusion for the surgical treatment of symptomatic disc degeneration in properly indicated patients. The CHARITE artificial disc group demonstrated statistically significant superiority in two major economic areas, a 1-day shorter hospitalization, and a lower rate of reoperations (5.4% compared with 9.1%). At 24 months, the investigational group had a significantly higher rate of satisfaction (73.7%) than the 53.1% rate of satisfaction in the control group (P = 0.0011). This prospective randomized multicenter study also demonstrated an increase in employment of 9.1% in the investigational group and 7.2% in the control group.
The Spine Journal, 2009
BACKGROUND CONTEXT: The CHARITÉ 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 CHARITÉ disc or any other artificial disc has been published to date. PURPOSE: 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 CHARITÉ 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. STUDY DESIGN/SETTING: Randomized controlled trialdfive-year follow-up. PATIENT SAMPLE: Ninety CHARITÉ patients and 43 BAK patients.
Neurosurgery, 2005
INTRODUCTION: Previous reports of lumbar total disc replacement (TDR) have described significant complications. The Food and Drug Administration investigational device exemption (IDE) study of the Charite ́ Artificial Disc represents the first Level I data comparison of TDR with fusion. METHODS: In the prospective, randomized, multicenter IDE study of the Charite ́ Artificial Disc, patients were randomized in a 2:1 ratio, with 205 patients in the Charite ́ group and 99 patients in the control group (anterior lumbar interbody fusion [ALIF] with Bagby and Kus- lich cages). Inclusion criteria included confirmed single-level degenerative disc disease from L4 to S1 and failure of nonoperative treatment for at least 6 months. Complications were reported throughout the study. RESULTS: The overall reported complication rate was equivalent between the two groups. Approach-related complications were equivalent between groups (9.8 versus 10.1%). Neurological complications were slightly higher in the control group (17.2 versus 16.1%). The incidence of superficial wound infection was higher in the TDR group (6.3 versus 2.0%), but there were no device-related or deep wound infections in either group. The incidence of retrograde ejaculation was 3.3% in the TDR group and 5.5% in the control group. Postoperative ileus presented in 1.0% in each group. Additional surgery at the operative level was performed in 5.4% of the TDR group and 8.1% of the control group. In the control group, the pseudarthrosis rate was 9.1%, and the rate of reported bone graft site pain was 18.2%. There were no catastrophic TDR device failures and no cases of osteolysis. There were seven (3.4%) device-related complications in the TDR group, with two requiring removal. CONCLUSION: The complication rate of TDR with the CHARITE ́ Artificial Disc is similar to that of ALIF in properly indicated patients. Training, experience, proper sizing and positioning of the prosthesis, and avoidance of overdistraction of the disc space will minimize complications.
Neurosurgery, 2004
INTRODUCTION: Prior reports of artificial disc replacements in the lumbar spine have been described retrospectively. We report the first results from a randomized controlled trial of the Charite ́ artificial disc replacement versus fusion for the treatment of lumbar degener- ative disc diseaseat one level. METHODS: The study was conducted after review and approval by the United States Food and Drug Administration and each site’s institutional review board. All enrolled subjects had failed at least 6 months of nonoperative management and were being treated for single-level symptomatic disc degeneration verified by radiographic diagnostic studies, including discography. After informed consent, 304 subjects from 15 centers were randomized using a 2:1 randomiza- tion scheme, with 205 subjects enrolled in the Charite ́ group (C) and 99 in the Fusion group (F) who had anterior lumbar interbody fusion (ALIF) with Bagby and Kuslich (BAK) cages and autograft. Demo- graphics were statistically similar (except for weight) between groups. All subjects were treated at one level, at either L4–L5 (C = 61, F = 32) or L5–S1 (C = 144, F = 67) via a mini-ALIF retroperitoneal approach. Clinical outcomes were determined by visual analog score (VAS), Oswestry (ODI), Short-Form 36 questionnaires, and subject satisfac- tion. RESULTS: Mean operative time (C = 111 min, F = 114 min) and perioperative blood loss (C = 207 ml, F = 209 ml) were equivalent. The length of hospital stay was significantly less in the Charite ́ group (3.7 versus 4.3 d) compared with the Fusion group. The VAS and ODI scores improved significantly in both groups, with the Charite ́ group experiencing significantly greater improvement than the Fusion group at all time points but the 24-month follow-up. Subject satisfaction was significantly higher in the Charite ́ group (C = 77%, F = 59%). Aside from graft site pain in 17% of the fusion group, the complication rates were similar for both groups. CONCLUSION: The results of this prospective, randomized study supports the proposition that Charite ́ artificial disc replacement is a safe and effective alternative to fusion for one-level symptomatic lumbar disc disease in appropriately selected patients.
Journal of Neurosurgery: Spine, 2004
Arthrodesis is the gold standard for surgical treatment of lumbar degenerative disc disease (DDD). Solid fusion, however, can cause stress and increased motion in the segments adjacent to the fused level. This may initiate and/or accelerate the adjacent-segment disease process. Artificial discs are designed to restore and maintain normal motion of the lumbar intervertebral segment. Restoring and maintaining normal motion of the segment reduces stresses and loads on adjacent level segments. A US Food and Drug Administration Investigational Device Exemptions multicentered study of the Charité artificial disc was completed. The control group consisted of individuals who underwent anterior lumbar interbody fusion involving BAK cages and iliac crest bone graft. This is the first report of Class I data in which a lumbar artificial disc is compared with lumbar fusion. Of 304 individuals enrolled in the study, 205 were randomized to the Charité disc-treated group and 99 to the BAK fusion-treated (control) group. Neurological status was equivalent between the two groups at 6, 12, and 24 months postoperatively. The number of patients with major, minor, or other neurological complications was equivalent. There was a greater incidence of both major and minor complications in the BAK fusion group at 0 to 42 days postoperatively. Compared with data reported in the lumbar fusion literature, the Charité disc-treated patients had equivalent or better mean changes in visual analog scale and Oswestry Disability Index scores. The Charité artificial disc is safe and effective for the treatment of single-level lumbar DDD, resulting in no higher incidence of neurological complications compared with BAK-assisted fusion and leading to equivalent or better outcomes compared with those obtained in the control group and those reported in the lumbar fusion literature.
SAS Journal, 2007
Previous reports of lumbar total disc replacement (TDR) have described significant complications. The US Food and Drug Administration (FDA) investigational device exemption (IDE) study of the Charité artificial disc represents the first level I data comparison of TDR to fusion. In the prospective, randomized, multicenter IDE study, patients were randomized in a 2:1 ratio, with 205 patients in the Charité group and 99 patients in the control group (anterior lumbar interbody fusion [ALIF] with BAK cages). Inclusion criteria included confirmed single-level degenerative disc disease at L4-5 or L5-S1 and failure of nonoperative treatment for at least 6 months. Complications were reported throughout the study. The rate of approach-related complications was 9.8% in the investigational group and 10.1% in the control group. The rate of major neurological complications was similar between the 2 groups (investigational = 4.4%, control = 4.0%). There was a higher rate of superficial wound infection in the investigational group but no deep wound infections in either group. Pseudarthrosis occurred in 9.1% of control group patients. The rate of subsidence in the investigational group was 3.4%. The reoperation rate was 5.4% in the investigational group and 9.1% in the control group. The incidence of perioperative and postoperative complications for lumbar TDR was similar to that of ALIF. Vigilance is necessary with respect to patient indications, training, and correct surgical technique to maintain TDR complications at the levels experienced in the IDE study.
INTRODUCTION: Survivorship of orthopaedic implants are traditionally defined as the percentage of patients at a given time, post- surgery, who have not had a reoperation for any reason. To date, survivorship of lumbar artificial disc prostheses has not been re- ported. METHODS: Records from patients enrolled in the investigational device exemption study of the CHARITE ́ Artificial Disc were analyzed at four high-enrollment sites. Patients enrolled in one of the three arms of the study: nonrandomized, randomized, and continued access. The total enrollment across all sites for these three arms was 688 patients, including 99 who were enrolled in the randomized control group (anterior lumbar interbody fusion with BAK cages). Records were surveyed at the four sites. A reoperation included revision or replacement of the prosthesis, posterior decompression, or supplemental posterior fixation with or without fusion and with or without decompression. A Kaplan-Meyer regression analysis was per- formed to predict the rate of survivorship at 5 years for both the CHARITE ́ Artificial Disc and the control group. RESULTS: A total of 359 patients were enrolled at the four sites, yielding 52.1% of the total cohort. Of these patients, 305 (51.8%) received total disc replacement (TDR) and 54 (54.5%) received the control. The mean duration of follow-up was 25.4 months (range, 1–68 mo). In the TDR group, 14 (4.6%) patients required reoperation, wherease, in the fusion group, seven (13.0%) required reoperation. The Kaplan-Meier analysis predicted a significant difference in survivorship in the TDR group (92.4%) compared with the fusion group (80.1%) at 5 years (P=0.0030). The rate of adjacent-level disease requiring reoperation was significantly less in the TDR group (two out of 305, 0.6%) compared with the fusion group (three out of 54, 5.6%) (P=0.0259). CONCLUSION: Survivorship is an important indicator of the success of a given implant and/or procedure. This analysis demonstrates the high rate of predicted survivorship of TDR with the CHARITE ́ Artificial Disc versus anterior lumbar interbody fusion at 5 years.
2009
Background Candidates for spinal arthrodesis or arthroplasty often present with a history of prior surgery such as laminectomy, laminotomy or discectomy. In this study, lumbar arthroplasty patients with prior surgery, and in particular patients with prior discectomy, were evaluated for their clinical outcomes at the 5-year time point. Methods Randomized patients from the 5-year CHARITÉ investigational device exemption (IDE) study were divided as follows: 1) fusion prior surgery (excluding prior decompression with fusion) group (FSG); 2) fusion prior discectomy group (FDG); 3) fusion no prior surgery group (FNG); 4) arthroplasty prior surgery group (ASG); 5) arthroplasty prior discectomy group (ADG); and 6) arthroplasty no prior surgery group (ANG). The 5-year clinical outcomes included visual analog scale (VAS), Oswestry Disability Index 2.0 (ODI), patient satisfaction, and work status. Results In the arthroplasty group, all subgroups had statistically significant VAS improvements f...