SPINE Volume 31, Number 19, pp 2270 –2276 ©2006, Lippincott Williams & Wilkins, Inc. 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 John J. Regan, MD,* Paul C. McAfee, MD,† Scott L. Blumenthal, MD,‡ Richard D. Guyer, MD,‡ Fred H. Geisler, MD, PhD,§ Rolando Garcia, Jr., MD, MPH, and James H. Maxwell, MD¶ Study Design. A prospective, randomized, multicen- ter, Food and Drug Administration regulated Investiga- tional 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 ex- perience 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 replace- ment consist of retrospective reviews with nonspeciﬁc indications. Methods. An analysis was performed of the Food and Drug Administration IDE Study of the Charite ´ 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 experi- ence) 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-enroll- ing surgeons versus low-enrolling surgeons; and ran- domized 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 sur- geons and institutions showed signiﬁcantly shorter op- erating times, length of hospital stay, and complication rates. High-enrolling surgeons had signiﬁcantly fewer de- vice 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 param- eters that provide a clinical and/or economic beneﬁt. Sur- geons 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. Key words: lumbar spine, total disc replacement, arti- ﬁcial disc, surgical volume, randomized study, Investiga- tional Device Exemption trial. Spine 2006;31:2270 –2276 High-surgical volume is associated with better clinical out- comes across a wide range of procedures and conditions. This has been an intense area of research for insurers, purchasers, and health care consumer groups. Birkmeyer et al 1,2 used Medicare claims databases to derive the “evidence based hospital referral” standards of the Leap- Frog Group, a coalition of more than 145 Fortune 500 companies representing 34 million health plan enrollees. Surgeon volume had a signiﬁcant impact on the clinical results of 10 operative procedures (coronary artery by- pass graft, aortic valve replacement, aortic abdominal aneurysm repair, esophagectomy, pancreatic resection, etc.). The investigators stated, “The volume of individual surgeons had more of an impact on outcomes than a hospital’s total volume.” The only orthopedic surgical procedures included in these analyses were total hip replacement and total knee replacement, each of which had lower dislocation rates, infections, and complications with high surgical volume. Katz et al 3 recently conﬁrmed the data reported for total knee replacement. The investigators published lower rates of complications and a lower risk of adverse out- come in patients who had total knee replacement per- formed by surgeons who did 50 total knee replacement procedures annually. Halm et al 4 performed a literature review of case volume for a wide array of treatments and procedures. The investigators reported that 69% of the studies they reviewed showed a statistically signiﬁcant correlation between physician case volume and clinical From the *West Coast Spine Institute, Beverly Hills, CA; †Spine and Scoliosis Center, St. Joseph’s Hospital, Towson, MD; ‡Texas Back Institute, Plano, TX; §Illinois Neuro-Spine Center, Aurora, IL; Aven- tura Hospital and Medical Center, Aventura, FL; and ¶Scottsdale Spine Care Center, Scottsdale, AZ. Acknowledgment date: May 6, 2005. First revision date: September 8, 2005. Second revision date: October 28, 2005. Third revision date: November 18, 2005. Fourth revision date: November 30, 2005. Ac- ceptance date: December 2, 2005. The device(s)/drug(s) is/are FDA-approved or approved by correspond- ing national agency for this indication. Corporate/Industry funds were received in support of this work. One or more of the author(s) has/have received or will receive beneﬁts for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g., honoraria, gifts, consul- tancies, royalties, stocks, stock options, decision making position. Address correspondence and reprint requests to John J. Regan, MD, West Coast Spine Institute, 120 S. Spalding Drive, Suite 400, Beverly Hills, CA 90212; E-mail: jjregan@spinesource.com 2270