Contact information
Type
Scientific
Primary contact
Dr Keith Greenfield
ORCID ID
Contact details
Department of Neurosurgery
Frenchay Hospital
Frenchay Healthcare NHS Trust
Frenchay
Bristol
BS16 1LE
United Kingdom
+44 (0)117 970 1212 ext 2366
keith.greenfield@bristol.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 93/09/17
Study information
Scientific title
Controlled trial of microdiscectomy for lumbar disc herniation
Acronym
Study hypothesis
The UK has one of the lowest rates for lumbar disc surgery in the western world. A robust randomised controlled trial, incorporating a health economic analysis, is needed, considering the lack of evidence about clinical outcome and cost effectiveness, particularly in the medium and long term. Microdiscectomy, the standard surgical procedure, will be compared to conservative management. The study will be based in two neurosurgical departments, both leading centres for disc surgery.
Follow-up will be at 3, 6, 12, 18 and 24 months, incorporating outcome measures of proven reliability and validity. The objectives of this project at to:
1. establish the efficacy and cost-effectiveness of surgical management for this patient group
2. to evaluate costs to health care purchasers of surgical and conservative management. A supplementary study will undertake follow-up at 3, 4, and 5 years, although funding is not being applied for at this stage.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Musculoskeletal diseases: Spinal conditions
Intervention
Please note that, as of 14 January 2008, the anticipated end date of this trial has been updated from 31 March 2001 to 30 June 2002.
Interventions:
Microdiscectomy, the standard surgical procedure, will be compared to conservative management.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/07/1996
Overall trial end date
30/06/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration.
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/07/1996
Recruitment end date
30/06/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Neurosurgery
Bristol
BS16 1LE
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
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