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11 February 2012
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| [ Print-friendly version ] |
| Flexible or solid stabilisation for lumbar spondylosis? A randomised controlled trial - Stage 1 - Feasibility Study |
| ISRCTN | ISRCTN33762516 |
| ClinicalTrials.gov identifier | |
| Public title | Flexible or solid stabilisation for lumbar spondylosis? A randomised controlled trial - Stage 1 - Feasibility Study |
| Scientific title | |
| Acronym | FleSS |
| Serial number at source | 04/04 |
| Study hypothesis |
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 |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Lumbar spondylotic back pain |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/04/2005 |
| Anticipated end date | 30/03/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 30 Added 09/10/10: only 10 patients were recruited and the study ended ended 01/04/08. |
| Interventions | DYNESYS flexible posterolateral stabilisation (Intervention) versus Posterolateral fusion (PLF) with pedicle screws and graft |
| Primary outcome measure(s) | ODQ = Oswestry Disability Questionnaire |
| Secondary outcome measure(s) |
1. SF36
2. Pain Scale 3. Health Transitions scale 4. Target and adjacent segment motion characteristics |
| Sources of funding | Zimmer Ltd (UK) |
| Trial website | |
| Publications |
Results have been disseminated in the following communications:
1. Abnormal inter-vertebral motion is associated with chronic low back pain and MR disc degeneration. Fowler J, Mellor F, Muggleton J, Morris A, Senior C, Breen A. Spine Society of Europe. Annual Meeting. Istanbul, Oct 2006 (poster presentation). 2. Sensitivity and specificity of objective spinal motion imaging analysis (OSMIA) in detecting lumbar discs that have significant MR degeneration. Mellor F, Breen A, Fowler J, Senior C, Muggleton J. European Congress of Radiology, Vienna, March 2007. 3. Sensitivity and Specificity of Objective Spinal Motion Imaging Analysis (OSMIA) in Detecting Lumbar Discs that have Significant MR Degeneration Mellor F, Breen A, Fowler J. Senior C, Muggleton F. Hogg J. European Congress on Radiology. Vienna. March 2007 (Platform Presentation). 4. Lumbar inter-vertebral motion: What the OSMIA technology is teaching us. Breen A British Chiropractic Association/Anglo-European College of Chiropractic Joint Spring Conference. Bournemouth. March 2007 (invited lecture). 5. Adjacent segment motion and posterior lumbar spine instrumentation: a comparison of patient groups A Breen, J Fowler, F Mellor. Spine Arthroplasty Society. Global Symposium on Motion Preservation Technology. Berlin, May 2007 (poster presentation) 6. Biomechanics of the degenerate disc. A Breen – Plenary presentation. European Chiropractors’ Union Congress, Brussells, April 2008. 7. Objective clinical investigation of disogenic back pain – the future. A Breen – Plenary presentation. European Chiropractors’ Union Congress, Brussells, April 2008. 8. Clinical biomechanics of flexible stabilisation. J Fowler, F Mellor, A Breen – Paper presented at the Royal College of Surgeons, London, May 16, 2008 Further related papers since 2008: 9. Does non-specific back pain have anything to do with inter-vertebral motion? An inconclusive study. AC Breen, FE Mellor, W Mason, J Bagust, J Fowler. Journal of Bone and Joint Surgery (Br) (abstract) November 7, 2008. 10. Objective assessment of spinal motion:The future? Mellor FE, Breen AC. Imaging and Oncology 2009 34-41. 11. Mid-lumbar lateral flexion stability measured in healthy volunteers by in-vivo fluoroscopy. Mellor FE, Muggleton JM, Bagust J, Mason W, Thomas P, Breen AC. Spine 2009 Oct 15;34(22):E811-E817. |
| Contact name | Prof Alan Breen |
| Address |
IMRCI-AECC
13-15 Parkwood Road |
| City/town | Bournemouth |
| Zip/Postcode | BH5 2DF |
| Country | United Kingdom |
| Tel | +44 (0)1202 436275 |
| Fax | +44 (0)1202 436278 |
| imrci.abreen@aecc.ac.uk | |
| Sponsor | Zimmer Ltd (UK) |
| Address |
The Courtyard
Lancaster Place South Marston Park |
| City/town | Swindon |
| Zip/Postcode | SN3 4FP |
| Country | United Kingdom |
| Date applied | 30/09/2004 |
| Last edited | 09/11/2010 |
| Date ISRCTN assigned | 03/11/2004 |
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| © 2012 ISRCTN unless otherwise stated. | |
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