Prosthetic intervertebral disc replacement in the lumbar spine (interventional procedures consultation)
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional procedure consultation document
Interventional procedure overview of prosthetic intervertebral disc replacement in the lumbar spine
| As a person gets older, discs supporting the back bones can deteriorate because of wear and tear. Sometimes this causes such severe pain and disability that surgery is indicated; usually removal of the damaged disc. Prosthetic intervertebral disc replacement in the lumbar spine involves insertion of an artificial disc in the place of the damaged disc. Depending on the amount of damage, a person may have one or more discs replaced during the same operation. |
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The National Institute for Health and Clinical Excellence (NICE) is examining interventional procedure overview of prosthetic intervertebral disc replacement in the lumbar spine and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about prosthetic intervertebral disc replacement in the lumbar spine. This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:
Note that this document is not NICE's formal guidance on this procedure. The recommendations are provisional and may change after consultation. The process that NICE will follow after the consultation period ends is as follows.
For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual). NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate. Closing date for comments: 24 April 2009 Target date for publication of guidance: July 2009 |
| 1 | Provisional recommendations |
| 1.1 | Current evidence on the safety and efficacy of prosthetic intervertebral disc replacement in the lumbar spine is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit. |
| 1.2 | A multidisciplinary team with specialist expertise in the treatment of degenerative spine disease should be involved in patient selection for prosthetic intervertebral disc replacement in the lumbar spine. The procedure should only be carried out in patients for whom conservative treatment options have failed or are contraindicated. |
| 1.3 | The current evidence is based on studies with maximum follow-up of 13 years. NICE encourages clinicians to continue to collect and publish data on longer-term outcomes, which should include information about patient selection and the need for further surgery. |
| 2 | The procedure |
| 2.1 | Indications and current treatments |
| 2.1.1 | Symptomatic degenerative disc disease of the lumbar spine occurs when the intervertebral discs supporting the vertebrae lose their elasticity. This can cause partial disc prolapse, which may be associated with lower back and radicular pain. |
| 2.1.2 | Conservative treatments include analgesics, non-steroidal anti-inflammatory medication and physical therapy. Epidural steroid injections can also be used. Interventions for people with chronic intractable pain or neurological complications include removal of the protruding disc (discectomy), laser lumbar discectomy and/or spinal fusion. |
| 2.2 | Outline of the procedure |
| 2.2.1 | Artificial intervertebral discs are mobile implants which are inserted between the vertebrae. They are designed to resolve symptoms associated with disc degeneration and to reduce disc degeneration between adjacent lumbar vertebrae. |
| 2.2.2 | With the patient under general anaesthesia, the intervertebral space is accessed through an abdominal incision using a transabdominal or retroperitoneal approach. The damaged disc is partially or fully removed, and the implant inserted, taking care to ensure that the size of replacement disc and its position within the intervertebral space are optimised to promote osseous integration and to maximise disc mobility and patient comfort. Multiple discs can be replaced during the same procedure. |
| Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/IP126aoverview. |
| 2.3 | Efficacy |
| 2.3.1 | A randomised controlled trial (RCT) of 304 patients (205 treated with a prosthetic lumbar disc and 99 with spinal fusion) used the Oswestry Disability Index (ODI) to assess outcomes: this involves a 10-item questionnaire on a scale from 0% to 100% (low scores better). The RCT reported significantly greater improvement from baseline in ODI score in patients treated by prosthetic disc implantation compared with spinal fusion at 6-week, 3-month, and 6-month follow-up (absolute figures and level of significance not stated). At 12-month and 24-month follow-up, the ODI score was no longer significantly different from baseline (absolute figures not stated; p = 0.14, p = 0.54, respectively). |
| 2.3.2 | An RCT of 236 patients (161 treated with a prosthetic lumbar disc and 75 with spinal fusion) reported that mean quality of life score (using the Short Form-36 questionnaire) improved by 87% in the prosthetic disc group compared with 70% who underwent spinal fusion (p = 0.004) at 3-month follow-up. This difference was no longer statistically significant at 24-month follow-up (p = 0.09). |
| 2.3.3 | A case series of 106 patients treated with a prosthetic lumbar disc implantation reported that 42% (45/106) had ‘excellent’, 40% (42/106) ‘good’, 8% (8/106) ‘fair’, and 10% (11/106) ‘poor’ clinical outcomes (on a 4-grade Stauffer Coventry scale from poor [no improvement or worse than preoperative condition] to excellent [no pain, treatment or medications]) at a mean follow-up of 13-years. In the same study, 90% (86/96) of patients eligible for work at baseline had returned to work, and 78% (28/36) had returned to manual labour (mean follow-up 13 years). |
| 2.3.4 | Specialist Advisers listed key efficacy outcomes as pain relief measured by a visual analogue scale or ODI, disability, return to work, quality of life, and reduced need for additional procedures. |
| 2.4 | Safety |
| 2.4.1 | In an RCT of 67 patients vertebral endplate fracture requiring further surgery occurred in 2% (1/44) of patients who underwent insertion of prosthetic intervertebral discs in the lumbar spine. None of the patients treated by spinal fusion had this complication. |
| 2.4.2 | The RCT of 304 patients reported that the rate of major neurological adverse events (not otherwise described) was higher after fusion surgery (5.4%) than after prosthetic disc implantation (2.4%) at 42-day follow-up (absolute figures and significance not stated). |
| 2.4.3 | A non-randomised controlled study of 688 patients reported need for further surgery within 2 years in 9% (52/589) of patients treated with prosthetic lumbar discs compared with 10% (10/99) of patients treated by lumbar fusion (significance not stated). |
| 2.4.4 | A systematic review of 27 uncontrolled case series totalling 2490 patients treated with prosthetic lumbar discs reported that intervertebral disc disease (defined as clinically significant degeneration) occurred in 14% (173/1216) of patients treated by fusion compared with 1% (7/595) of patients treated with prosthetic lumbar discs (p < 0.001) (length of follow-up varied between studies). |
| 2.4.5 | The RCT of 236 patients reported that infection (not otherwise described) had occurred in 3% (2/75) of patients treated by lumbar fusion and 0% (0/161) of patients treated with prosthetic lumbar discs at 2-year follow-up (significance not stated). |
| 2.4.6 | Specialist Advisers listed anecdotal or published adverse outcomes as vascular injury, spinal endplate fracture, retrograde ejaculation, failure to control symptoms, device subsidence, and wear debris from the device. The Specialist Advisers considered theoretical adverse events to include nerve injury (including cauda equina injury), bowel injury, haemorrhage, infection, impaired bladder function, and device failure requiring revision surgery. |
| 3 | Further information |
| 3.1 | NICE has published interventional procedures guidance and a clinical guideline is in development on low back pain. For more information see www.nice.org.uk. |
Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
December, 2008
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It is the responsibility of consultees to accurately cite academic work in order that they can be validated.
This page was last updated: 30 March 2010