Controlled trial of microdiscectomy for lumbar disc herniation

ISRCTN	ISRCTN25126860
DOI	https://doi.org/10.1186/ISRCTN25126860
Secondary identifying numbers	HTA 93/09/17

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 24/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Keith Greenfield
Scientific

Department of Neurosurgery
Frenchay Hospital
Frenchay Healthcare NHS Trust
Frenchay
Bristol
BS16 1LE
United Kingdom

Phone	+44 (0)117 970 1212 ext 2366
Email	keith.greenfield@bristol.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	Controlled trial of microdiscectomy for lumbar disc herniation
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Not provided at time of registration.
Secondary outcome measures	Not provided at time of registration.
Overall study start date	01/07/1996
Completion date	30/06/2002

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration.
Key inclusion criteria	Not provided at time of registration.
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/07/1996
Date of final enrolment	30/06/2002

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Neurosurgery

Bristol
BS16 1LE
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

24/05/2016: No publications found, verifying study status with principal investigator