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

Svante Berg

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Disc Disease Degenerative Disk Degeneration Disc Disease Lumbar

Interventions

Anterior Lumbar Interbody FusionPROCEDURE

Anterior Lumbar Fusion(ALIF)

Total Disc ReplacementPROCEDURE

Total Disc Replacement

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Spine Center Göteborg

Gothenburg, Sweden

Outcomes

Primary Outcomes

ODI, Oswestry Disability Index

ODI questionnaire. ODI (Oswestry disability index, self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel, 0-5 zero indicating the least amount of disability and 5 indicating most severe disability)

Time frame: Two years

Secondary Outcomes

VAS, Visual Analogue Scale

VAS Scale, VAS (Visual Analogue Scale, 0 no pain, 100 worst possible pain) of back and leg,collected from questionnaires

Time frame: Two years

Segment Mobility

Flexion Extension X-ray

Time frame: Two years

Patient reported back pain after two years in Swespine national registry

GA (Global Assessment of back pain, patient-based evaluation of leg and back pain as compared to preoperatively,1-5, 1 disappeared and 5 worsened) ,collected from questionnaires

Time frame: Two years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.