Condition category
Musculoskeletal Diseases
Date applied
30/09/2004
Date assigned
03/11/2004
Last edited
09/11/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Zimmer Ltd (UK)

Sponsor details

The Courtyard
Lancaster Place
South Marston Park
Swindon
SN3 4FP
United Kingdom

Sponsor type

Industry

Website

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.

Publication citations

Additional files

Editorial Notes