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

Study Overview
=================
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.

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

Conditions
-----------------
Disc Disease Degenerative, Disk Degeneration, Disc Disease Lumbar

Intervention / Treatment
-----------------
* Procedure: Anterior Lumbar Interbody Fusion
* Procedure: Total Disc Replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anterior Lumbar Interbody Fusion<br>Surgical treatment Anterior Lumbar Interbody Fusion | Procedure: Anterior Lumbar Interbody Fusion<br>* Anterior Lumbar Fusion(ALIF)<br>|
| Active Comparator: Total disc replacement<br>Surgical treatment total disc replacement in the lumbar spine | Procedure: Total Disc Replacement<br>* Total Disc Replacement<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS, Visual Analogue Scale | VAS Scale, VAS (Visual Analogue Scale, 0 no pain, 100 worst possible pain) of back and leg,collected from questionnaires | Two years | 
| Segment Mobility | Flexion Extension X-ray | 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 | Two years |