Biomedical subjects

Scott L Blumenthal

Publications and source records attributed to Scott L Blumenthal.

9 recordsLinked to original sources

PubMed2006

Evaluation of surgical volume and the early experience with lumbar total disc replacement as part of the investigational device exemption study of the Charité Artificial Disc.

STUDY DESIGN: A prospective, randomized, multicenter, Food and Drug Administration regulated Investigational Device Exemption (IDE) clinical trial. OBJECTIVES: 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. SUMMARY OF BACKGROUND DATA: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Adolescent↗

PubMed2006

Revisability of the CHARITE artificial disc replacement: analysis of 688 patients enrolled in the U.S. IDE study of the CHARITE Artificial Disc.

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 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 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 = 0.0562). At 2 years or more follow-up, 93.9%(553/589 = 93.9%) of patients receiving TDR with the CHARITE Artificial Disc had a successfully functioning prosthesis with a mean of over 7 degrees of flexion-extension mobility. CONCLUSIONS: Lumbar TDR with the CHARITE 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.

Adult↗

PubMed2004

Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charité intervertebral disc. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004.

OBJECT: 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. METHODS: 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. CONCLUSIONS: 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.

Biomechanical Phenomena↗

PubMed2003

Prospective study evaluating total disc replacement: preliminary results.

For many years, there has been an interest in disc replacements. There are a few retrospective studies from Europe reporting promising results for these devices. The purpose of this study is to review the preliminary results of the SB Charité disc replacement device in a prospective study. The study group consists of a consecutive series of our first 57 patients who received the Link SB Charité device implanted through a mini-open anterior approach. The primary clinical indications for disc replacement were single-level symptomatic disc disease at L4-L5 or L5-S1 and no significant facet joint changes. The outcome data include the Visual Analog Scale (VAS) assessing pain intensity and the Oswestry Low Back Pain Disability Questionnaire. Data were collected prior to surgery and at 6 weeks, 3 months, 6 months, and 12 months after surgery. Twenty-four-month follow-up data are currently being collected. The mean VAS score improved 50.8% by the 6-week follow-up, and significant improvement was maintained throughout follow-up. The mean Oswestry score improved 38.7% at the 6-week follow-up, and further slight improvement was noted during the later follow-up periods. This study found that significant improvements were achieved by the 6-week postoperative visit in the pain and disability scores following disc replacement surgery. Significant improvement was maintained through the 12-month follow-up visit. Although these preliminary results are encouraging, long-term follow-up and a greater number of patients are needed to further evaluate the outcome of these devices.

Adolescent↗

PubMed2002

Artificial disc: preliminary results of a prospective study in the United States.

Artificial discs have been used in Europe for many years with good results. This technology has recently been available in the United States on a limited, investigational basis. The purpose of this study is to review the preliminary results of one center's experience using the SB Charité III disc replacement. The study group consisted of the series of our first consecutive 56 patients who received the Link SB Charité III artificial disc. There were 25 men and 31 women, with a mean age of 39.9 years. All patients had single-level symptomatic disc disruption at L4-5 or L5-S1. The discs were implanted using the same approach as used for mini-open anterior lumbar interbody fusion procedures. The primary data recorded included visual analog scales (VAS) assessing pain and the Oswestry Disability Questionnaire. Data were collected pre-operatively and at 6 weeks, 3 months, 6 months, and 12 months post-operatively. Peri-operative data as well as complications were recorded. At the time of this preliminary study, 22 patients have reached the 12-month post-operative follow-up period. There was a significant improvement in the VAS and Oswestry scores at the 6-week follow-up period. These improvements were maintained throughout the 12-month follow-up period. The preliminary results of this prospective study indicate that the artificial disc yields significant improvement that is maintained during a 12-month follow-up. Data from more patients and with longer follow-up are needed to determine whether these results can be maintained in the long term.

Adolescent↗

PubMedDate not supplied

Prospective randomized study of the Charite artificial disc: data from two investigational centers.

BACKGROUND CONTEXT: For decades there has been a desire to restore motion of a painful degenerated spinal segment. Artificial discs have been used in Europe for almost 20 years. In the few reports available in the literature, the results have been promising. However, there have been no prospective randomized studies comparing artificial discs with spinal fusion. PURPOSE: The purpose of this study was to determine if patients with symptomatic degenerative disc disease treated with Charite artificial disc (DePuy Spine, Raynham, MA) arthroplasty would show significant improvement in functional outcome measures and to compare these results to fusion. STUDY DESIGN/SETTING: This was a prospective randomized clinical trial comparing total disc replacement with anterior lumbar interbody fusion using cages. The data reported were collected from two spine specialty centers participating in a Food and Drug Administration regulated trial. METHODS: A consecutive series of 144 patients were randomized using a 2:1 ratio of Charite versus BAK (Zimmer Spine, Minneapolis, MN). All patients were being treated for single-level discogenic pain confirmed by plain radiography, magnetic resonance imaging and provocative discography. Data were collected at designated follow-up periods for up to 24 months. RESULTS: The mean age was 40.1 years (range, 21 to 56 years). Forty-four cases had BAK anterior interbody fusion, and 100 cases were randomized to Charite disc replacement. The mean operating time was 76.2 minutes (range, 54 to 137 minutes) for the Charite cases. The mean estimated blood loss was 196.2 cc (range, 50 to 1,800 cc). Most patients were discharged in 1 to 2 days with a soft corset and returned to normal activities within 3 weeks if they underwent the disc replacement. The mean Oswestry Disability Index score for the BAK group was 69.6+/-12.8 preoperatively and 27.5+/-26.4 at 24-month follow-up (p<.001) The corresponding mean Oswestry score for the Charite disc patients was 70.9 preoperatively and 30.0 at 24-month follow-up (p<.001). CONCLUSIONS: In this prospective randomized study, both surgical groups improved significantly. Complications of total disc replacement were similar to those encountered with anterior lumbar interbody fusion. Total disc replacement appears to be a viable alternative to fusion for the treatment of single-level symptomatic disc degeneration unresponsive to nonoperative management.

Adult↗

PubMedDate not supplied

To the editor.

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Female↗

PubMedDate not supplied

Artificial intervertebral discs and beyond: a North American Spine Society Annual Meeting symposium.

BACKGROUND CONTENT: This is a synopsis of a symposium presented to the North American Spine Society Annual Meeting in Seattle, WA, 2001. PURPOSE: To bring to the reader who may not have attended the symposium a distillation of the material presented on this frontier of spinal surgery. METHODS: Panel presentation. RESULTS: The proposed indication for artificial disc replacement is a degenerated but contained disc, painful to the point of major life-style interruption, refractory to at least 1 year of nonoperative treatment, preferably at a single lumbar level and without infection, listhesis or major facet joint disease or spinal stenosis. Total disc replacements have been developed and used mostly in Europe. Disc nucleus replacements have also been developed. No disc replacement has been approved for general use in North America as yet. The US Food and Drug Administration is conducting investigational device exemption studies at this time. CONCLUSIONS: Artificial disc replacement is not a new concept, the first attempts having been done in the early 1950s. During the past 15 years, considerable advance has been made with large numbers of patients, mostly in Europe, having surgery with either total disc prostheses or disc nucleus replacements. Only with truly scientific studies using patient randomization, pre- and postsurgery outcome analyses by unbiased independent observers and statistical analysis by independent experts will the real value of these devices be realized.

Biocompatible Materials↗

PubMedDate not supplied

Intervertebral cages for degenerative spinal diseases.

Interbody fusion techniques have been used for many years for the treatment of a variety of lumbar spine diagnoses. Part of the interest in increasing methods of interbody fusion has stemmed from concern that posterior fusion alone may allow micro-motion, which may generate pain in a ruptured or degenerated disc. Stabilization of the anterior segment led to the development of interbody fusion cages. These devices were designed to stabilize the spine while bony ingrowth from the vertebrae to the bone graft occurred. There are a variety of techniques for cage insertion, including open and laparoscopic techniques anteriorly, and open posterior approach. A lateral approach for cage placement has also been reported. The purpose of this paper is to present a review of the literature on lumbar intervertebral fusion performed using interbody cages. The reported results for these procedures vary, but in general the majority of patients have had favorable results. The complications are similar to those encountered with traditional interbody fusion procedures using bone grafts. There is a learning curve associated with the procedures, particularly with the laparoscopic techniques. Appropriate training for the spine surgeon as well as the access surgeon is important. There is a great deal of disparity in reports on using the cages as stand-alone devices as well as on laparoscopic approaches. Overall, the use of interbody cages for fusion appears to be a viable treatment, yielding good results. Fusion cages appear to have a role in spine care; however, as with any procedure, patient selection and proper training of the surgeon are critical.

Humans↗