Biomedical subjects

Stephen H Hochschuler

Publications and source records attributed to Stephen H Hochschuler.

4 recordsLinked to original sources

PubMed2005

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.

STUDY DESIGN: A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial. OBJECTIVES: 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. SUMMARY OF BACKGROUND DATA: Reported results of lumbar total disc replacement have been favorable, but studies have been limited to retrospective case series and/or small sample sizes. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Adult↗

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↗