NCT03674190

A Study Comparing the Outcome of Anterior Lumbar Fusion and Total Lumbar Disc Replacement

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Svante Berg · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Total lumbar disc replacement has previously been compared to posterior fusion of the lumbar spine, showing some favor towards total disc replacement. The study aims to compare total disc replacement to anterior fusion, sparing the muscles of the back and thus comparing the two different methods using the same surgical approach.

Detailed description

A total of 170 patients are planned to be enrolled in the study. If the patients meet the inclusion criteria and accept to participate they will be randomized to either anterior lumbar fusion or total disc replacement. The method of choice will be blinded for the patients until the two year follow up is completed. Follow-up: after one and two years. Questionnairs: ODI, VAS, EuroQol, and GA Flexion- Extension X-ray after one and two years Complications will be retrieved from the patient journals.

Conditions

• Disc Disease Degenerative
• Disk Degeneration
• Disc Disease Lumbar

Interventions

Type	Name	Description
PROCEDURE	Anterior Lumbar Interbody Fusion	Anterior Lumbar Fusion(ALIF)
PROCEDURE	Total Disc Replacement	Total Disc Replacement

Timeline

• Start date: 2018-09-04
• Primary completion: 2020-10-01
• Completion: 2022-10-01
• First posted: 2018-09-17
• Last updated: 2020-12-16

Locations

1 site across 1 country: Sweden