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 |
| Protocol serial number | N0188149742 |
| Sponsor | Department of Health |
| Funder | Lancashire Teaching Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 27/10/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Mr S Ghalayini
Scientific
Scientific
Orthopaedics
Chorley and South Ribble Hospital
Preston Road
Chorley
PR7 1PP
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) | 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. |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 01/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 50 |
| 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Chorley and South Ribble Hospital
Chorley
PR7 1PP
United Kingdom
PR7 1PP
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
