|
ISRCTN
|
ISRCTN88702314
|
|
ClinicalTrials.gov identifier
|
|
|
Public 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
|
|
Scientific title
|
|
|
Acronym
|
CELAX - Cost Effectiveness of lumbar LAminectomy versus X-STOP®
|
|
Serial number at source
|
07/X01
|
|
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. Date of approval: 01/04/2008 (ref: 08/H0711/12)
|
|
Study design
|
Multicentre, prospective, randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Neurogenic intermittent claudication secondary to lumbar spinal stenosis
|
|
Participants - 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 1 or 2 adjacent levels between L1-S1 confirmed by X-ray, computerised tomography (CT) or magnetic resonance imaging (MRI) scan
|
|
Participants - 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
|
|
Anticipated start date
|
01/06/2008
|
|
Anticipated end date
|
01/06/2011
|
|
Status of trial
|
Ongoing
|
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
110 (55 in each treatment group)
|
|
Interventions
|
Participants will be randomly allocated to the following two treatment groups:
1. X-STOP® interspinous distractor
2. Lumbar laminectomy
|
|
Primary outcome measure(s)
|
Cost of implanting X-stop interspinous distractor compared to conventional surgical decompression
|
|
Secondary outcome measure(s)
|
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)
|
|
Sources of funding
|
Kyphon Europe (Belgium)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Mr
David
Choi
|
|
Address
|
Department of Neurosurgery
National Hospital for Neurology and Neurosurgery
Queen Square
|
|
City/town
|
London
|
|
Zip/Postcode
|
WC1N 3BG
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)845 155 5000
|
|
Email
|
david.choi@uclh.nhs.uk
|
|
Sponsor
|
University College London Hospitals NHS Foundation Trust (UK)
|
|
Address
|
c/o Mr Philip Diamond
Research and Development Department
1st Floor
Maple House
149 Tottenham Court Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
W1T 7NF
|
|
Country
|
United Kingdom
|
|
Email
|
philip.diamond@uclh.nhs.uk
|
|
Sponsor website:
|
http://www.uclh.nhs.uk
|
|
Date applied
|
06/05/2008
|
|
Last edited
|
04/06/2008
|
|
Date ISRCTN assigned
|
04/06/2008
|
