[CONFERENCE ABSTRACT] Complications of lumbar artificial disc replacement versus fusion: results from the randomized, multicenter FDA IDE study of the CHARITE artificial disc (#806) (original) (raw)
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Spine, 2006
Study Design. A prospective, randomized, multicenter, FDA-regulated Investigational Device Exemption clinical trial. Objectives. To analyze the incidence of, and reasons for, reoperation in all patients (treatment and control) enrolled in the IDE study. Summary of Background Data. This is the first report of the incidence and nature of reoperations following lumbar TDR as part of a controlled, prospective, multi-center trial. Methods. A total of 688 patients meeting the inclusion and exclusion criteria were enrolled in one of three arms of the study at 14 centers across the United States. This cohort includes 71 nonrandomized cases, 205 randomized cases, and 313 continued access cases, all receiving the CHARITE Artificial Disc, as well as 99 randomized cases in the control group (ALIF with threaded fusion cages and autograft). A detailed analysis was performed of clinical chart notes, operative notes, and adverse event reports for all patients requiring reoperation following their index surgery. Results. Of the 589 patients with TDR, 52 (8.8%) required reoperation. Of the 99 patients with lumbar fusion, 10 (10.1%) required reoperation, and an additional 2 required surgery for adjacent level disease (P=0.7401). There were 24 TDR patients who underwent a repeated anterior retroperitoneal approach, with 22 (91.7%) having had a successful removal of the prosthesis. Seven of the 24 TDR prostheses requiring removal were revised to another CHARITE Artificial Disc. The mean time to re-operation in all patients was 9.7 months. A total of 29 patients (4.9%) in the TDR group required posterior instrumentation and fusion as did 10 (10.1%) in the control group (P=0.0562). At 2 years or more follow-up, 93.9%
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.
Revisability of the CHARITÉ Artificial Disc Replacement
Spine, 2006
Study Design. A prospective, randomized, multicenter, FDA-regulated Investigational Device Exemption clinical trial. Objectives. To analyze the incidence of, and reasons for, reoperation in all patients (treatment and control) enrolled in the IDE study. Summary of Background Data. This is the first report of the incidence and nature of reoperations following lumbar TDR as part of a controlled, prospective, multicenter trial. Methods. A total of 688 patients meeting the inclusion and exclusion criteria were enrolled in one of three arms of the study at 14 centers across the United States. This cohort includes 71 nonrandomized cases, 205 randomized cases, and 313 continued access cases, all receiving the CHARITÉ Artificial Disc, as well as 99 randomized cases in the control group (ALIF with threaded fusion cages and autograft). A detailed analysis was performed of clinical chart notes, operative notes, and adverse event reports for all patients requiring reoperation following their index surgery. Results. Of the 589 patients with TDR, 52 (8.8%) required reoperation. Of the 99 patients with lumbar fusion, 10 (10.1%) required reoperation, and an additional 2 required surgery for adjacent level disease (P ϭ 0.7401). There were 24 TDR patients who underwent a repeated anterior retroperitoneal approach, with 22 (91.7%) having had a successful removal of the prosthesis. Seven of the 24 TDR prostheses requiring removal were revised to another CHARITÉ Artificial Disc. The mean time to reoperation in all patients was 9.7 months. A total of 29 patients (4.9%) in the TDR group required posterior instrumentation and fusion as did 10 (10.1%) in the control group (P ϭ 0.0562). At 2 years or more follow-up, 93.9% (553/589 ϭ 93.9%) of patients receiving TDR with the CHARITÉ Artificial Disc had a successfully functioning prosthesis with a mean of over 7°of flexion-extension mobility. Conclusions. Lumbar TDR with the CHARITÉ Artificial Disc did not preclude any further procedures at the index level during primary insertion, with nearly one third being revisable to a new motion-preserving prosthesis and just over two thirds being successfully converted to ALIF and/ or posterior pedicle screw arthrodesis, the original alternative procedure.
Neurosurgery, 2005
INTRODUCTION: Total disc replacement (TDR) offers several ad- vantages compared with fusion for surgical treatment of lumbar de-TDR is instrumented posterolateral fusion. However, circumstances may necessitate removal or replacement of the prosthesis. Previous authors have described the anecdotal incidence of revision and reop- eration after lumbar TDR. This is the first report of the incidence and nature of reoperations after lumbar TDR as part of a controlled, prospective, multicenter trial. METHODS: With Institutional Review Board approval and in- formed consent, records were reviewed for subjects in the CHARITE ́ investigational device exemption pivotal trial, requiring reoperation and/or revision after surgical treatment with either the CHARITE ́ Artificial Disc (71 training, 205 randomized, 313 continued access) or anterior lumbar interbody fusion (ALIF) with Bagby and Kuslich (BAK) cages (99 randomized). RESULTS: Of 688 enrolled patients, 58 required revision or reoperation: 48 of 589 (8.1%) in the CHARITE ́ group and 10 of 99 (10.1%) in the BAK group. The most common related complaints necessitating reoperation were persistent pain, pseudoradicular symptoms, lower extremity cramping, and mechanical back pain. Supplemental posterior fixation was used in 18 CHARITE ́ cases and 8 BAK cases. There were 18 removals in the CHARITE ́ group and 1 in the BAK group. In the CHARITE ́ group, 5 removals were because of migration over 3 mm, and 5 were because of instability caused by unrecognized isthmic pars defects/fractures (a protocol deviation). Five of 18 CHARITE ́ prostheses requiring removal were successfully revised by placement of another CHARITE ́ prosthesis. The remaining 13 were revised to an ALIF or 360-degree fusion. CONCLUSION: The CHARITE ́ Artificial Disc did not “burn any bridges” during primary insertion, with more than one-quarter being revisable with a new prosthesis. The primary revision strategy should be supplemental posterior fixation. If prosthesis removal is indicated, great care should be taken to avoid major vascular complications during reoperation.
Outcomes of CHARITE Lumbar Artificial Disk versus Fusion: 5-Year Data
Seminars in Spine Surgery, 2012
ABSTRACT Lumbar total disk replacement (TDR) has been used for the treatment of painful disk degeneration since the 1980s. Not until the Food and Drug Administration (FDA) regulated trials in the United States initiated in 2000 had there been formal prospective randomized trials evaluating the results of this technology compared with fusion, the traditional surgical treatment for disk degeneration. The purpose of this article was to provide a commentary on the results of the 5-year follow-up of CHARITÉ artificial disk (DePuy Spine, Raynham, MA) published by Guyer et al (Spine J 9:374-386, 2009) and to comment on this work in the context of other TDR literature. In the study, results of TDR using the CHARITÉ artificial disk, were compared with those of anterior lumbar interbody fusion (ALIF) with BAK cages and iliac crest autograft, for the treatment of single-level degenerative disk disease from L4 to S1. The results of the 5-year, prospective, randomized multicenter study were consistent with the 2-year outcomes. The TDR group had improved functional outcomes based on visual analog pain scales, Oswestry Disability Index, and the SF-36 Physical component scores. CHARITÉ patients reached a greater rate of part- and full-time employment and a statistically lower rate of long-term disability compared with ALIF patients. Radiographically, the range of motion at the index and adjacent levels was maintained. The incidence of adjacent level degeneration was lower for TDR than in the fusion group. The results of this study indicate that TDR with the CHARITE produced results similar or superior to ALIF at 5-year follow-up.
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.
Spine, 2006
A prospective, randomized, multicenter, Food and Drug Administration regulated Investigational Device Exemption (IDE) clinical trial. To discern whether there is a correlation between surgical volume and clinical outcomes, as well as the complication rate and perioperative data points, for lumbar total disc replacement. To examine the early experience for lumbar total disc replacement as part of an IDE study. To our knowledge, an analysis of the effect of surgical volume has not been performed for any spine surgical procedure. Prior reports of the early experience with lumbar total disc replacement consist of retrospective reviews with nonspecific indications. An analysis was performed of the Food and Drug Administration IDE Study of the Charité Artificial Disc (DePuy Spine, Inc., Raynham, MA). Patients enrolled in the control group were omitted from the analysis. Up to 5 nonrandomized cases (representing the early experience) were performed at each site before beginning the randomized arm of the study. There were 3 comparisons performed: nonrandomized cases (71) versus randomized cases (205); randomized cases performed by high-enrolling surgeons versus low-enrolling surgeons; and randomized cases at high-volume institutions versus low-volume institutions. The high-enrolling groups had a significantly lower mean hospital stay and operating time compared to the low-enrolling groups (P < 0.05). High-enrolling surgeons and institutions showed significantly shorter operating times, length of hospital stay, and complication rates. High-enrolling surgeons had significantly fewer device failures and cases of neurologic deterioration. Mean operating time and hospital stay were significantly lower in the randomized group (P < 0.05) compared to the nonrandomized group. Blood loss and approach-related complications were similar between the 2 groups. Device failure requiring removal was 4.2% in the nonrandomized group and 1.5% in the randomized group. Surgeons and institutions with a high volume of lumbar total disc replacement cases have a reduction in key perioperative and postoperative parameters that provide a clinical and/or economic benefit. Surgeons may expect longer hospital stays, higher blood loss, and a higher rate of certain complications in their early experience with total disc replacement procedures, but there was no effect on clinical outcomes.
The CHARITÉ Artificial Disc: Design History, FDA IDE Study Results, and Surgical Technique
Clinical Neurology, 2006
INTRODUCTION Lumbar fusion serves to eliminate abnormal motion and instability at symptomatic degenerated levels, subsequently reducing or eliminating low back pain in patients with degenerative disc disease (DDD). Reported clinical outcomes for these procedures vary widely. A meta-analysis of lumbar fusion procedures performed by Geisler et al. demonstrated the elimination of lumbar segmental motion that resulted in a significant reduction in pain and subsequent improvement in disability level. Fusion is successful in many cases because the abnormal motion itself is the root cause of pain. When the segment is fused, it no longer moves and cannot, therefore, cause pain. Fusion, however, can result in stress and increased motion in the segments adjacent to the fused level, as demonstrated by Cunningham et al. This may initiate and/or accelerate the degenerative disease process in adjacent segments. Reported rates of adjacent-level disease requiring re-operation after lumbar fusion range from 20 to 35%.11,12 The inherent problem with surgical arthrodesis of the degenerative lumbar segment is that it merely masks the true disease process by eliminating the intervertebral motion and its normal physiological function.
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.
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.