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Difficult to find patients that accepted the study
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| Name | Class |
|---|---|
| Yara Asterfjord | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anterior Lumbar Interbody Fusion | Experimental | Surgical treatment Anterior Lumbar Interbody Fusion |
|
| Total disc replacement | Active Comparator | Surgical treatment total disc replacement in the lumbar spine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior Lumbar Interbody Fusion | Procedure | Anterior Lumbar Fusion(ALIF) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Svante Berg, MD, PhD | Karolinska Institutet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spine Center Göteborg | Gothenburg | SE-42130 | Sweden |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| C535531 | Intervertebral disc disease |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D059145 | Total Disc Replacement |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Total Disc Replacement | Procedure | Total Disc Replacement |
|
| 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 |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |