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Artificial disc replacement
Artificial disc replacement (ADR) was first reviewed by the HTA program in 2008.
- In 2016, an update literature search of ADR was conducted to determine if newly available evidence published since the original assessment could change the 2008 coverage determination.
- In 2017, a re-review of artificial disc replacement was conducted.
Artificial disc replacement was selected for re-review 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 non-surgical treatment.
Primary criteria ranking
- Safety = Medium/High
- Efficacy = High
- Cost = Medium
- Final key questions (8/02/16)
- Draft evidence report: peer review, public comment and response (12/5/16)
- Final evidence report (12/19/16)
- Final evidence review: appendices (12/19/16)
- Final findings and decision (3/17/17)
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 as well as 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.
A health technology assessment titled: Artificial Disc Replacement, was published on September 19, 2008 by the Health Care Authority. The resulting findings and coverage decision were released on October 17, 2008 and adopted on March 20, 2009. Based on a signal update report (1/25/2016), new randomized controlled trials for lumbar and cervical ADR have been published subsequent to the 2008 report. In addition, longer-term follow-up of patients is now available for some of these trials, and at least one device has subsequently received FDA approval for two-level placement.