Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
27/10/2015
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 S Ghalayini

ORCID ID

Contact details

Orthopaedics
Chorley and South Ribble Hospital
Preston Road
Chorley
PR7 1PP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0188149742

Study information

Scientific title

Prospective, Randomised Blinded trial to compare outcome following lumbar discectomy and DYNESYS® dynamic distraction stabilisation for symptomatic isolated contained single level lumbar disc prolapse.

Acronym

Study hypothesis

To determine whether there is a significant difference in outcome between patients undergoing lumbar discectomy and those undergoing DYNESYS® dynamic distraction stabilisation for patients who have symptomatic isolated, contained single level lumbar disc prolapse confirmed on MRI scanning, causing straight leg sciatica.

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

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

Surgery: Discectomy

Intervention

RCT comparing outcome following lumbar discectomy and DYNESYS® dynamic distraction stabilisation.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Change in functional scores and 10 point visual analogue pain scores following surgery. Carried out pre-operatively as a baseline and then at 6 weeks, 6 months, 1 year and 2 years.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2004

Overall trial end date

01/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients awaiting surgery for isolated single level lumbar disc prolapse seen on MRI with straight leg sciatica aged 25-60 years old.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 participants to be recruited.

Participant exclusion criteria

Patients with
1. other spinal pathology
2. previous spinal surgery
3. Cauda Equina syndrome
4. severe neurological dysfunction
5. very large prolapses

Recruitment start date

01/08/2004

Recruitment end date

01/08/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Chorley and South Ribble Hospital
Chorley
PR7 1PP
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Lancashire Teaching Hospitals NHS Trust (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