Search Results

You are looking at 1 - 2 of 2 items for

  • Author or Editor: Peggy Boltes x
  • Refine by Access: all x
Clear All Modify Search
Restricted access

Prospective randomized controlled study of the Bryan Cervical Disc: early clinical results from a single investigational site

Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2005

Domagoj Coric, Frederick Finger, and Peggy Boltes

Object

The authors report on a prospective randomized controlled multicenter trial in which they compared the clinical outcomes obtained in patients who underwent the placement of a Bryan Cervical Disc System with those obtained in patients who underwent anterior cervical discectomy and fusion (ACDF). In the present study, they evaluated the safety and effectiveness of the artificial disc based on data obtained at a single investigational site.

Methods

Patients with primary, single-level cervical disc disease producing radiculopathy and/or myelopathy were randomized prospectively to undergo anterior cervical discectomy with either fusion or artificial disc placement. The patients were evaluated with pre- and postoperative serial radiographic studies; the authors also evaluated neck disability indices, visual analog scale scores for pain, 36-Item Short Form Health Survey scores, and neurological status at 1.5, 3, 6, 12, and 24 months.

Analysis of the early results obtained in the 33 patients indicated an absence of device-related complications. Preliminary analysis revealed that improvement in all clinical outcome measures was excellent for both treatment groups; however, in patients treated with the artificial cervical disc, motion at the treated level was maintained.

Conclusions

The preliminary results documented at this investigational site are encouraging. Evaluation of data acquired in the Bryan disc treatment group showed that improvements in the clinical parameters were similar to those in the fusion group. Additionally in the artificial disc–treated group, there was radiographic evidence that motion was maintained.

It is theorized that motion preservation may potentially reduce the rate of adjacent-level cervical disc disease that has been documented in patients who undergo ACDF.

Restricted access

Domagoj Coric, Ahmad Nassr, Paul K. Kim, William C. Welch, Stephen Robbins, Steven DeLuca, Donald Whiting, Ali Chahlavi, Stephen M. Pirris, Michael W. Groff, John H. Chi, Jason H. Huang, Roland Kent, Robert G. Whitmore, Scott A. Meyer, Paul M. Arnold, Ashvin I. Patel, R. Douglas Orr, Ajit Krishnaney, Peggy Boltes, Yoram Anekstein, and Michael P. Steinmetz

OBJECTIVE

The purpose of this study was to evaluate the safety and efficacy of a posterior facet replacement device, the Total Posterior Spine (TOPS) System, for the treatment of one-level symptomatic lumbar stenosis with grade I degenerative spondylolisthesis. Posterior lumbar arthroplasty with facet replacement is a motion-preserving alternative to lumbar decompression and fusion. The authors report the preliminary results from the TOPS FDA investigational device exemption (IDE) trial.

METHODS

The study was a prospective, randomized controlled FDA IDE trial comparing the investigational TOPS device with transforaminal lumbar interbody fusion (TLIF) and pedicle screw fixation. The minimum follow-up duration was 24 months. Validated patient-reported outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain. The primary outcome was a composite measure of clinical success: 1) no reoperations, 2) no device breakage, 3) ODI reduction of ≥ 15 points, and 4) no new or worsening neurological deficit. Patients were considered a clinical success only if they met all four measures. Radiographic assessments were made by an independent core laboratory.

RESULTS

A total of 249 patients were evaluated (n = 170 in the TOPS group and n = 79 in the TLIF group). There were no statistically significant differences between implanted levels (L4–5: TOPS, 95% and TLIF, 95%) or blood loss. The overall composite measure for clinical success was statistically significantly higher in the TOPS group (85%) compared with the TLIF group (64%) (p = 0.0138). The percentage of patients reporting a minimum 15-point improvement in ODI showed a statistically significant difference (p = 0.037) favoring TOPS (93%) over TLIF (81%). There was no statistically significant difference between groups in the percentage of patients reporting a minimum 20-point improvement on VAS back pain (TOPS, 87%; TLIF, 64%) and leg pain (TOPS, 90%; TLIF, 88%) scores. The rate of surgical reintervention for facet replacement in the TOPS group (5.9%) was lower than the TLIF group (8.8%). The TOPS cohort demonstrated maintenance of flexion/extension range of motion from preoperatively (3.85°) to 24 months (3.86°).

CONCLUSIONS

This study demonstrates that posterior lumbar decompression and dynamic stabilization with the TOPS device is safe and efficacious in the treatment of lumbar stenosis with degenerative spondylolisthesis. Additionally, decompression and dynamic stabilization with the TOPS device maintains segmental motion.