Condition category
Circulatory System
Date applied
06/05/2008
Date assigned
04/06/2008
Last edited
21/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

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 (0)845 155 5000
david.choi@uclh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

07/X01

Study information

Scientific title

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 following two treatment groups:
1. X-STOP® interspinous distractor
2. Lumbar laminectomy

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measures

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

01/06/2008

Overall trial end date

01/06/2011

Reason abandoned

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

01/06/2008

Recruitment end date

01/06/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Neurosurgery
London
WC1N 3BG
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
philip.diamond@uclh.nhs.uk

Sponsor type

Government

Website

http://www.uclh.nhs.uk

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes