Go Back   ISPINE.ORG Forum > Main forums > Abstracts and Articles
FAQ Members List Calendar Search Today's Posts Mark Forums Read

Abstracts and Articles Discuss Evaluation of surgical volume and the early experience with lumbar total DR in the Main forums forums; From: PubMed. Spine. 2006 Sep 1;31(19):2270-6. Evaluation of surgical volume and the early experience with lumbar ...

Reply
 
LinkBack Thread Tools Display Modes
  #1 (permalink)  
Old 06-26-2008, 06:29 AM
Senior Member
 
Join Date: May 2008
Posts: 196
Default Evaluation of surgical volume and the early experience with lumbar total DR

From: PubMed. Spine. 2006 Sep 1;31(19):2270-6.

Evaluation of surgical volume and the early experience with lumbar total disc replacement as part of the Investigational Device Exemption Study of the Charite Artificial Disc
Regan JJ, McAfee PC, Blumenthal SL, Guyer RD, Geisler FH, Garcia R Jr, Maxwell JH

Abstract
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.

Keywords: lumbar spine; total disc replacement; artificial disc; surgical volume; randomized study; Investigational Device Exemption trial; CLINICAL-OUTCOMES; MULTICENTER
Reply With Quote
Reply

Bookmarks

Thread Tools
Display Modes

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off
Trackbacks are On
Pingbacks are On
Refbacks are On



All times are GMT. The time now is 12:30 PM.


Powered by vBulletin® Version 3.7.2
Copyright ©2000 - 2024, Jelsoft Enterprises Ltd.