About the Study

This research will enable us to assess if lumbar fusion surgery (LFS) is more clinically effective and cost effective than best conservative care (BCC) for people with persistent severe LBP and lumbar spine degenerative changes.

Objectives

To test for superiority of LFS versus BCC on back-related disability (physical function) in patients with severe persistent LBP and lumbar degenerative disease.
To investigate the cost-effectiveness of LFS compared with BCC.

FORENSIC - enrolment curve

Recruitment target: 270

Information about the Study

Study Design

A multicentre, 2 group (LFS and BCC) superiority RCT with integrated Recruitment Intervention Study (RIS), qualitative interview study and health economic analysis.

Participants

270 patients (135 per group) aged 18 to 65 years old with persistent, severe LBP with recent imaging evidence of lumbar spine degeneration who have already undergone recommended conservative treatment.

Primary Outcome Measure

Back-related physical function using the Oswestry Disability Index (ODI) at 24 months post randomisation

Intervention

Lumbar Fusion Surgery [LFS] (& usual post-operative care)

Recruitment Duration

Recruitment is expected to last for 24 months

Funder and Reference ID

NHMRC-NIHR Collaborative Research Grant Scheme ID 201572