Disc Disease Degenerative Clinical Trial
Official title:
A Study Comparing the Outcome of Anterior Lumbar Fusion and Total Lumbar Disc Replacement
NCT number | NCT03674190 |
Other study ID # | MollyMoa |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | September 4, 2018 |
Est. completion date | October 2022 |
Verified date | December 2020 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2022 |
Est. primary completion date | October 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Spine Center Göteborg | Göteborg | |
Sweden | Spine Center Göteborg | Gothenburg |
Lead Sponsor | Collaborator |
---|---|
Svante Berg | Yara Asterfjord |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Segment Mobility | Flexion Extension X-ray | Two years | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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