Artificial disc replacement
Artificial disc replacement (ADR) are disc prostheses developed to mimic the decompressive and supportive properties of intervertebral discs. ADR was selected for rereview based on new literature identified which may invalidate aspects of the previous report. This report addresses issues of efficacy, safety, and cost and compares ADR (cervical and lumbar) to current alternative treatments including fusion and nonsurgical treatment.
Status: Decision completed
Primary criteria ranking
- Safety = Medium/High
- Efficacy = High
- Cost = Medium
- Documents (all assessments)
- Final key questions
- Draft evidence report: comment and response
- Final evidence report
- Final evidence report: appendices
- Final findings and decision
Update literature (2016)
Assessment timeline (2016)
- Draft key questions published: June 28, 2016
- Public comment period: June 29 to July 13, 2016
- Final key questions published: July 29, 2016
- Draft report published: October 20, 2016
- Public comment period: October 21 to November 21, 2016
- Final report published: December 19, 2016
- HTCC public meeting: January 20, 2017
Back and neck pain due to degenerative disc disease (DDD) is the leading cause of pain and disability in adults in the United States, and as such, a large proportion of health care expenditures is used for the evaluation and treatment of this condition. Because aging is the primary risk factor for development of DDD, as the US population ages, the incidence of DDD is expected to increase.
Initially, treatment of symptomatic DDD typically consists of nonsurgical approaches, such as physical therapy, epidural steroid injections, and medications. However, an estimated 10% to 20% of people with lumbar DDD and up to 30% with cervical DDD are unresponsive to nonsurgical treatment. In addition, cervical DDD may lead to radiculopathy and/or myelopathy; 25% of people with cervical radiculopathy and 50% to 70% of those with cervical myelopathy do not respond to nonsurgical treatment.
Surgery may be considered when nonoperative treatments for at least six months fail to relieve symptoms attributed to spinal DDD or to prevent progression of nerve damage in the case of radiculopathy or myelopathy. Historically, lumbar or cervical fusion (also called arthrodesis) has been offered as a surgical option with the goal of removing the disc and fusing the vertebrae, thereby limiting the motion at the symptomatic segment. Spinal fusion is thought by some to promote the degeneration of the vertebrae above or below the fusion site (adjacent segment disease); however, many uncertainties remain regarding the extent to which this occurs. Guidelines recommend consideration of intensive multidisciplinary rehabilitation and appropriate patient selection as an integral part of decision making particularly for lumbar fusion. For cervical DDD resulting in radiculopathy or myelopathy, the current surgical standard is anterior cervical discectomy and spinal fusion (ACDF), the goal of which is nerve decompression and restoration of spinal alignment and stability.
A surgical alternative to fusion is artificial disc replacement (ADR). Disc prostheses were developed to mimic the decompressive and supportive properties of intervertebral discs, as well as to preserve motion at the index level, thereby improving pain and function, decreasing stresses on adjacent segment structures and theoretically the risk of adjacent segment disease. Lumbar ADR (L-ADR) is currently indicated in patients with single-level DDD who have failed at least six months of nonoperative care, while cervical ADR (C-ADR) is indicated in patients with radiculopathy or myelopathy secondary to one- or two-level DDD that has not responded to six weeks of nonsurgical treatment.