Lumbar spondylotic back pain Musculoskeletal Diseases Back pain
Conditions
Interventions
DYNESYS flexible posterolateral stabilisation (Intervention) versus Posterolateral fusion (PLF) with pedicle screws and graft
Sponsors
Zimmer Ltd (UK)
Eligibility
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ODQ = Oswestry Disability Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. SF36 2. Pain Scale 3. Health Transitions scale 4. Target and adjacent segment motion characteristics | — |
Countries
United Kingdom
Outcome results
None listed