Flexible or solid stabilisation for lumbar spondylosis? A randomised controlled trial - Stage 1 - Feasibility Study
| ISRCTN | ISRCTN33762516 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33762516 |
| Secondary identifying numbers | 04/04 |
- Submission date
- 30/09/2004
- Registration date
- 03/11/2004
- Last edited
- 09/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Alan Breen
Scientific
Scientific
IMRCI-AECC
13-15 Parkwood Road
Bournemouth
BH5 2DF
United Kingdom
| Phone | +44 (0)1202 436275 |
|---|---|
| imrci.abreen@aecc.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | FleSS |
| Study objectives | Rationale: There have been no clinical trials of the new flexible stabilisation, versus the old rigid stabilisation surgery for the large subgroup of chronic back patients who have lumbar spondylosis pain. Furthermore, there has previously been no assessment tool with which to explain the clinical biomechanics of any kind of stabilisation. Therefore, we wish to conduct a feasibility study for randomised controlled trial of rigid, versus flexible (DYNESYS) lumbar spine stabilisation using both patient-assessed and objective biomechanical outcomes. Objectives To conduct a feasibility study to inform the working methods and number of subjects needed for a single-blind randomised controlled trial to 1. Compare the effectiveness of flexible (DYNESYS) with posterolateral fusion with pedicle screws and graft (PLF) and 2. Seek explanatory and predictive models for clinical outcomes using an objective spinal motion imaging assessment (OSMIA) at instrumented and adjacent levels |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Lumbar spondylotic back pain |
| Intervention | DYNESYS flexible posterolateral stabilisation (Intervention) versus Posterolateral fusion (PLF) with pedicle screws and graft |
| Intervention type | Other |
| Primary outcome measure | ODQ = Oswestry Disability Questionnaire |
| Secondary outcome measures | 1. SF36 2. Pain Scale 3. Health Transitions scale 4. Target and adjacent segment motion characteristics |
| Overall study start date | 01/04/2005 |
| Completion date | 30/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 30 Added 09/10/10: only 10 patients were recruited and the study ended ended 01/04/08. |
| Key inclusion criteria | Subjects: Patients with severe chronic low back pain of at least 1 year's duration attributed to either post-discectomy pain or primary disc degeneration below L3 in whom conservative treatment has been ineffective and who elect to have spine stabilisation surgery. Inclusion Criteria: 1. Age 25-65 2. Willing to participate 3. Back pain without radiculopathy and attributable to lumbar spondylosis 4. Conservative therapy tried and failed 5. Elect lumbar stabilisation (1 or 2 level, L3 downward) 6. Suitable for DYNESYS or standard posterolateral fusion (PLF) with pedicle screws and graft using a standardised procedure 7. Oswestry >30 |
| Key exclusion criteria | 1. Mental illness (except mild depression) 2. No prior conservative therapy 3. Pathology such as fracture, infection, neoplasm 4. Poor understanding of English 5. Spinal stenosis 6. Spondyolisthesis 7. >2 level procedure required 8. Radicular pain 9. Litigation or compensation pending |
| Date of first enrolment | 01/04/2005 |
| Date of final enrolment | 30/03/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
IMRCI-AECC
Bournemouth
BH5 2DF
United Kingdom
BH5 2DF
United Kingdom
Sponsor information
Zimmer Ltd (UK)
Industry
Industry
The Courtyard
Lancaster Place
South Marston Park
Swindon
SN3 4FP
United Kingdom
"ROR" |
https://ror.org/00mke2t69 |
|---|
Funders
Funder type
Industry
Zimmer Ltd (UK)
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/10/2009 | Yes | No |
