Contact information
Type
Scientific
Primary contact
Prof Alan Breen
ORCID ID
Contact details
IMRCI-AECC
13-15 Parkwood Road
Bournemouth
BH5 2DF
United Kingdom
+44 (0)1202 436275
imrci.abreen@aecc.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
04/04
Study information
Scientific title
Acronym
FleSS
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
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
Not specified
Trial type
Treatment
Patient information sheet
Condition
Lumbar spondylotic back pain
Intervention
DYNESYS flexible posterolateral stabilisation (Intervention) versus Posterolateral fusion (PLF) with pedicle screws and graft
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
ODQ = Oswestry Disability Questionnaire
Secondary outcome measures
1. SF36
2. Pain Scale
3. Health Transitions scale
4. Target and adjacent segment motion characteristics
Overall trial start date
01/04/2005
Overall trial end date
30/03/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
30
Added 09/10/10: only 10 patients were recruited and the study ended ended 01/04/08.
Participant 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
Recruitment start date
01/04/2005
Recruitment end date
30/03/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
IMRCI-AECC
Bournemouth
BH5 2DF
United Kingdom
Funders
Funder type
Industry
Funder name
Zimmer Ltd (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
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.