Lateral (including extreme, extra and direct lateral) interbody fusion in the lumbar spine (interventional procedures consultation)
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional procedure consultation document
Lateral (including extreme, extra and direct lateral) interbody fusion in the lumbar spine
As a person gets older, the discs between the back bones that provide support can deteriorate because of wear and tear. Sometimes this causes such severe pain and disability that surgery is considered.
Lateral interbody spinal fusion involves the removal of all, or part, of the damaged disc and the insertion of a supportive structure, together with a fragment of bone from the hip. It aims to join the two back bones together to prevent movement of the painful joint. The procedure is done through a cut in the patient’s side.
The National Institute for Health and Clinical Excellence (NICE) is examining lateral interbody fusion 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 lateral interbody spinal fusion 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:
- comments on the provisional recommendations
- the identification of factual inaccuracies
- additional relevant evidence, with bibliographic references where possible.
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.
- The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
- The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.
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: 28 July 2009
Target date for publication of guidance: November 2009
1 Provisional recommendations
1.1 Current evidence on the safety and efficacy of lateral (including extreme, extra and direct lateral) interbody fusion in the lumbar spine is inadequate in quantity and quality. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2 Clinicians wishing to undertake lateral interbody fusion in the lumbar spine should take the following actions.
- Inform the clinical governance leads in their Trusts.
- Ensure that patients and their carers understand the uncertainty about the procedure’s safety and efficacy and provide them with clear written information. In addition, the use of NICE’s information for patients (‘Understanding NICE guidance’) is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]
- Audit and review clinical outcomes of all patients having lateral interbody fusion in the lumbar spine (see section 3.1).
1.3 This procedure should only be carried out by surgeons with specific training in the technique, who should perform their initial procedures with an experienced mentor.
1.4 NICE encourages further research into lateral interbody fusion in the lumbar spine. Research outcomes should include fusion rates, pain and functional scores, quality of life measures and the frequency of both early and late complications. NICE may review the procedure on publication of further evidence.
2 The procedure
2.1 Indications and current treatments
2.1.1 Chronic low back pain may result from degenerative change of the intervertebral discs supporting the vertebrae and/or spinal facet joints.
2.1.2 Conservative treatments include education and advice, posture and exercise training, manual therapies, analgesics, non-steroidal anti-inflammatory medication and acupuncture.
2.1.3 For cases of severe life-limiting chronic low back pain that is refractory to conservative interventions, surgery may be appropriate, such as bony fusion of vertebrae, insertion of a prosthetic intervertebral disc or non-rigid stabilisation techniques.
2.2 Outline of the procedure
2.2.1 The aim of lateral interbody fusion in the lumbar spine is to achieve a spinal fusion procedure via a lateral approach in order to avoid the major muscle groups in the back (posterior approach) or the organs and blood vessels in the abdomen (anterior approach).
2.2.2 The procedure is carried out with the patient under general anaesthesia. A probe is inserted under fluoroscopic guidance through the psoas muscle, to lie alongside the affected disc, via a lateral approach. A posterior incision is also sometimes made, to allow digital access for manipulation of the probe. Nerve monitoring is also sometimes used. Dilators are inserted around the probe, and a retractor is positioned to give the surgeon direct access to the spine. A discectomy is carried out and a cage implant inserted to hold the vertebrae in position, maintaining correct disc height and spine alignment. A bone graft (usually from the hip) is inserted between the two vertebral bodies, sometimes with additional support from screws, plates, or rods. The procedure may be done at more than one level during the same operation.
| 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/IP744overview |
2.3 Efficacy
2.3.1 A case series of 13 patients with low back pain in the absence of spinal canal stenosis who were refractory to 6 months of conservative treatment, treated by lateral interbody spinal fusion reported that the majority of patients needed only narcotic and non-steroidal anti-inflammatory drugs for postoperative analgesia, and that they were mobile on the first postoperative day (absolute figures not stated).
2.3.2 In a non-randomised controlled trial of 98 patients (58 treated by lateral interbody spinal fusion), mean estimated blood loss was reported as 136 millilitres in patients treated with a lateral approach and 489 millilitres in patients treated by an open posterolateral approach (p < 0.0001).
2.3.3 The Specialist Advisers listed key efficacy outcomes as fusion rates, pain scores, functional ability, walking distance and duration of hospital stay.
2.4 Safety
2.4.1 In the non-randomised controlled trial of 98 patients, there was no significant difference in the total complication rate between patients treated by lateral interbody spinal fusion (22.4%) and those treated by an open posterolateral approach (22.5%) (mean follow-up 15 months, absolute figures and significance not stated). The case series of 13 patients reported that all procedures were completed without complications, and that no postoperative critical care stays or blood transfusions were required.
2.4.2 In the non-randomised controlled trial of 98 patients, ipsilateral nerve root damage (L4) was reported in 3% (2/58) of patients treated by the lateral approach; residual motor disturbances were reported in both patients at 1-year follow-up.
2.4.3 A case report of two patients treated with lateral interbody spinal fusion with concurrent removal of a failed prosthetic disc reported that one patient developed transient weakness (not otherwise described), which resolved by the third day of follow-up. There were no neurological signs or symptoms reported during 10-month follow-up.
2.4.4 The Specialist advisers stated that anecdotal adverse events included lower limb dysaesthesia from nerve damage. Theoretical adverse events may include bleeding, nerve injury, cerebrospinal fluid leak, infection and failure of the spine to fuse.
3 Further information
3.1 This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published.
3.2 For related NICE guidance please see www.nice.org.uk
Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
July 2009
Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.
It is the responsibility of consultees to accurately cite academic work in order that they can be validated.