Authors' objectives:

"This Assessment will review the available evidence to determine if artificial lumbar disc replacement is an effective treatment for chronic degenerative disc disease." (from executive summary)

Authors' recommendations: Given what is known about fusion as a comparator treatment, both noninferiority trials may not provide evidence of efficacy. The specific noninferiority margins are not justified. The lower-than-expected success rates also raise additional questions regarding the validity of a noninferiority trial and the noninferiority margin selected. Viewed from the perspective of superiority trials, both trials are also suspect. The Charite trial showed little evidence of superiority, and the ProDisc analysis is problematic because of missing values and uncertain outcomes for all patients. Based on the available evidence, the Blue Cross and Blue Shield Medical Advisory Panel made the following judgments about whether the artificial lumbar disc for treatment of degenerative disc disease meets the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) criteria. 1. The technology must have final approval from the appropriate governmental regulatory bodies. In October 2004, the U.S. Food and Drug Administration (FDA) granted premarket application (PMA) approval for the Charite Artificial Disc, stating that the device is indicated for spinal arthroplasty in skeletally mature patients with DDD at one level from L4-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. As a condition of approval, the manufacturer has agreed to conduct a postapproval study, using a maximum of 366 patients (201 randomized investigational subjects, 67 training investigational subjects, and 98 control subjects). Postapproval study patients will be evaluated for a period of 5 years post-implantation. The FDA granted approval to the ProDisc in August 2006 and is indicated for spinal arthroplasty in skeletally mature patients with DDD at one level from L3-S1. Patients should have no more than Grade 1 spondylolisthesis at the involved level. Patients receiving the ProDisc should have failed at least 6 months of conservative treatment prior to implantation. The manufacturer agreed to conduct a postapproval study to obtain 5-year follow-up data from all subjects in the clinical study. The study will utilize the same endpoints as the Investigational Device Exemption clinical study, and also evaluate adjacent segment degeneration and correlation of range-of-motion with Oswestry Disability Index and visual analog scale scores. 2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes. Current evidence supporting the effectiveness of artificial lumbar disc is insufficient. Case series evidence is inadequate to establish efficacy. The randomized trials of the Charite disc and ProDisc are suspect as valid noninferiority trials and do not prove superiority. 3. The technology must improve the net health outcome; and 4. The technology must be as beneficial as any established alternatives. The evidence is insufficient to determine whether the use of artificial lumbar discs improves the net health outcome or whether they are as beneficial as any established alternatives. 5. The improvement must be attainable outside the investigational settings. Whether the use of artificial lumbar discs improves health outcomes has not been established in the investigational settings. Therefore, the use of artificial lumbar discs for degenerative disc disease does not meet the TEC criteria.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.bcbs.com/blueresources/tec/contact-tec.html

Year Published: 2007

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: BlueCross BlueShield Association

Contact Address: BlueCross BlueShield Association, Technology Evaluation Center, 225 North Michigan Ave, Chicago, Illinois, USA. Tel: 888 832 4321

Contact Name: tec@bcbsa.com

Contact Email: tec@bcbsa.com

Copyright: BlueCross BlueShield Association (BCBS)