Plain English Summary
Background and study aims
Lumbar spinal stenosis is a common condition of the spine affecting mainly the older population. It causes back pain and pain down the legs and impairs mobility, therefore it has a negative impact on the individual’s quality of life. An operation can help to alleviate some of these symptoms. Laminectomy is the standard operation that is offered however this is quite invasive and not always successful. It also has a considerable risk of complications. A new device called X-stop is an implant that can be inserted in between the bones of the spine to achieve the same effect or similar to a laminectomy. The latter is a relatively minor operation where the risk of complications is less, however, the device itself is very expensive and is not proven to be better than a laminectomy. The aim of the study is to find out which operation results in a better quality of life and which one is more cost-effective.
Who can participate?
Adult patients with lumbar spinal stenosis
What does the study involve?
Patients with Lumbar Spinal Stenosis who are candidates for surgery and who agree to participate in the trial are randomly allocated to either a Laminectomy or X-Stop operation. They are asked to complete questionnaires before and after surgery and are followed up for two years.
What are the possible benefits and risks of participating?
Patients follow normal NHS pathways and as such there are no benefits to participate in the trial. The follow up for the trial is two years however, and normally patients would be discharged before that. Therefore, participants in the trial are likely to get longer follow up than usual. Participation is voluntary and patients may withdraw from the study at any point. Patients who agree to participate are unable to choose which operation they will have. Also they are asked to complete several questionnaires prior to surgery and again at 6, 12 and 24 months post operatively which wouldn’t be required outside the trial.
Where is the study run from?
1. The National Hospital for Neurology and Neurosurgery (UK)
2. St George’s Hospital (UK)
3. Hurstwood Park Neuroscience centre (UK)
When is the study starting and how long is it expected to run for?
April 2008 yo August 2017
Who is funding the study?
Kyphon Europe (Belgium)
Who is the main contact?
Mr David Choi
david.choi@uclh.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mr David Choi
ORCID ID
Contact details
Department of Neurosurgery
National Hospital for Neurology and Neurosurgery
Queen Square
London
WC1N 3BG
United Kingdom
+44 845 155 5000
david.choi@uclh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
07/X01
Study information
Scientific title
Cost effectiveness and quality of life after treatment of lumbar spinal stenosis with the X-STOP® Interspinous Process Distraction (IPD) device or laminectomy: a prospective randomised trial
Acronym
CELAX - Cost Effectiveness of lumbar LAminectomy versus X-STOP®
Study hypothesis
Null hypothesis: There is no difference in cost effectiveness, clinical efficacy, quality of life and safety of the X-STOP® device compared to that of conventional lumbar decompressive surgery.
Ethics approval
Charing Cross Research Ethics Committee, 01/04/2008, ref: 08/H0711/12
Study design
Multicentre prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Neurogenic intermittent claudication secondary to lumbar spinal stenosis
Intervention
Participants will be randomly allocated to the one of two treatment groups. A five block randomisation process will be used and patients are randomised the day before surgery.
Lumbar laminectomy: Participants receive a standard surgical decompression where the laminae at the affected level are removed. The operating surgeon’s discretion is used to determine the extent of the decompression including undercutting of the facet joints and whether a drain is required.
X-STOP® interspinous distractor: Patients have the device inserted at the affected level.
Participants in both groups complete follow up questionnaires post-operatively, and after six months and one and two years.
Intervention type
Device
Phase
Not Applicable
Drug names
Primary outcome measure
Cost of implanting X-stop interspinous distractor compared to conventional surgical decompression
Secondary outcome measures
The following will be assessed preoperatively, on discharge, at 6 weeks, 6, 12 and 24 months:
1. Quality of life, assessed by the EQ-5D, 36-item Short Form health survey (SF-36) and Quebec Back Pain Disability Questionnaire
2. Clinical efficacy, assessed by the Zucher Claudication Questionnaire (ZCQ), Oswestry Disability Index (ODI) and visual analogue scale (VAS)
3. Safety (any complication either perioperatively or postoperatively)
Overall trial start date
01/04/2008
Overall trial end date
01/08/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age: 18-80
2. Sex: males and non-pregnant females
3. Chronic leg pain with or without back pain of greater than 6 months duration, partially or completely relieved by adopting flexed posture and who are suitable candidates for posterior lumbar surgery
4. Those who have completed at least 6 months of conservative treatment without obtaining adequate symptomatic relief
5. Degenerative changes at one or two adjacent levels between L1-S1 confirmed by X-ray, computerised tomography (CT) or magnetic resonance imaging (MRI) scan
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
110 (55 in each treatment group)
Participant exclusion criteria
1. Fixed motor deficit
2. Active infection or metastatic disease
3. Degenerative spondylolisthesis >= Meyerding Grade 2
4. Known allergy to implant materials
5. Severe osteoporosis or rheumatoid arthritis
6. Cauda equina syndrome
Recruitment start date
11/12/2008
Recruitment end date
01/02/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The National Hospital for Neurology and Neurosurgery
Queen Square
London
WC1N 3BG
United Kingdom
Trial participating centre
St George’s Hospital
Blackshaw Road
London
SW17 0QT
United Kingdom
Trial participating centre
Hurstwood Park Neuroscience centre
Princess Royal Hospital
Hayward’s Heath
RH16 4EX
United Kingdom
Sponsor information
Organisation
University College London Hospitals NHS Foundation Trust (UK)
Sponsor details
c/o Mr Philip Diamond
Research and Development Department
1st Floor
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
+44 845 155 5000
philip.diamond@uclh.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Kyphon Europe (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a per reviewed journal.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Anouk Bord (anouk.borg@nhs.net)
Intention to publish date
01/08/2018
Participant level data
Available on request
Basic results (scientific)
Publication list