Controlled trial of microdiscectomy for lumbar disc herniation
| ISRCTN | ISRCTN25126860 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25126860 |
| Protocol serial number | HTA 93/09/17 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
Scientific
Department of Neurosurgery
Frenchay Hospital
Frenchay Healthcare NHS Trust
Frenchay
Bristol
BS16 1LE
United Kingdom
| Phone | +44 (0)117 970 1212 ext 2366 |
|---|---|
| keith.greenfield@bristol.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Not provided at time of registration. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 30/06/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
Department of Neurosurgery
Bristol
BS16 1LE
United Kingdom
BS16 1LE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
24/05/2016: No publications found, verifying study status with principal investigator
