An interventional study of Anterior Lumbar Interbody Fusion and Total Disc Replacement in Disc Disease Degenerative, Disk Degeneration and Disc Disease Lumbar, sponsored by Svante Berg. Withdrawn at 2 sites in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-12-16.
Sponsored by Svante Berg · Not applicable, Interventional, and Treatment
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.
267 studies on the registry are indexed under Spinal Diseases; 54 are open to participants now.
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Exclusion Criteria:
Surgical treatment Anterior Lumbar Interbody Fusion
Procedure: Anterior Lumbar Interbody Fusion
Surgical treatment total disc replacement in the lumbar spine
Procedure: Total Disc Replacement
Anterior Lumbar Fusion(ALIF)
Total Disc Replacement
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
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
Plan to share: No
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This study is withdrawn, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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