Condition category
Musculoskeletal Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
24/05/2016
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

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

http://www.dh.gov.uk/en/index.htm

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

Publication citations

Additional files

Editorial Notes

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