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

Svante Berg

Status

Withdrawn

Conditions

Disc Disease Lumbar

Disc Disease Degenerative

Disk Degeneration

Treatments

Procedure: Anterior Lumbar Interbody Fusion

Procedure: Total Disc Replacement

Study type

Interventional

Funder types

Other

Identifiers

NCT03674190

MollyMoa

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with disabling pain from degenerative disc disease(DDD) both clinical and radiological, in one or two segments of the lumbar spine from L4-S1, were prolonged conservative treatment has failed.
The patient should be able to understand swedish written and spoken.
The patient should be between the ages 18-65. The patient has to accept to participate in the study

Exclusion criteria

More than two degenerated segments.
Degeneration above the L4 segment.
Did not agree to participate in the study
Previous history of tumor, vertebral fracture, infection, lumbar fusion and dominating leg pain.
Need for posterior decompression
Pregnancy
Psychiatric illness or drug abuse