Flexible or solid stabilisation for lumbar spondylosis? A randomised controlled trial - Stage 1 - Feasibility Study

Completed

• Conditions: umbar spondylotic back pain; Musculoskeletal Diseases; Back pain

• Registration Number: ISRCTN33762516
• Lead Sponsor: Zimmer Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11-03
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified