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

ISRCTN	ISRCTN94607160
DOI	https://doi.org/10.1186/ISRCTN94607160
Secondary identifying numbers	N0188149742

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

Mr S Ghalayini
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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.
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Discectomy
Intervention	RCT comparing outcome following lumbar discectomy and DYNESYS® dynamic distraction stabilisation.
Intervention type	Procedure/Surgery
Primary outcome measure	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 study start date	01/08/2004
Completion date	01/08/2007

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	50 participants to be recruited.
Key inclusion criteria	Patients awaiting surgery for isolated single level lumbar disc prolapse seen on MRI with straight leg sciatica aged 25-60 years old.
Key exclusion criteria	Patients with 1. other spinal pathology 2. previous spinal surgery 3. Cauda Equina syndrome 4. severe neurological dysfunction 5. very large prolapses
Date of first enrolment	01/08/2004
Date of final enrolment	01/08/2007

Chorley and South Ribble Hospital

Chorley
PR7 1PP
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Hospital/treatment centre

Lancashire Teaching Hospitals NHS Trust (UK)

No information available

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