Disc Disease Degenerative, Disk Degeneration, Disc Disease Lumbar
Conditions
Brief 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.
Interventions
PROCEDUREAnterior Lumbar Interbody Fusion
Anterior Lumbar Fusion(ALIF)
PROCEDURETotal Disc Replacement
Total Disc Replacement
Sponsors
Yara Asterfjord
Svante Berg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ODI, Oswestry Disability Index | Two years | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS, Visual Analogue Scale | Two years | VAS Scale, VAS (Visual Analogue Scale, 0 no pain, 100 worst possible pain) of back and leg,collected from questionnaires |
| Segment Mobility | Two years | Flexion Extension X-ray |
| Patient reported back pain after two years in Swespine national registry | Two years | 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 |
Countries
Sweden
Outcome results
None listed