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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00444405 |
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Date of registration:
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06/03/2007 |
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Primary sponsor: |
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Public title:
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Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation
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Scientific title:
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Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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4 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT00444405 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Alan M. Scarrow, MD, JD |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. John's Health System, Missouri |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Recurrent lumbar disc herniation by MRI or CT with history of decompression at the
same level in the past
- Recurrent symptomatic history (with or without back pain) with radicular leg pain
that improved following the first surgery
- Male or female 18-75 years old
- Flexion and extension x-rays that demonstrate an absence of sponylolisthesis or
spondylolisthesis with less than 3 mm of movement
Exclusion Criteria:
- Recurrence of disc herniation within 3 months of first decompression
- Multiple level herniated discs
- No history of lumbar back surgery except as in Inclusion criteria above
- Documented severe osteoporosis or osteopenia
- Symptoms of low back pain only
- Diabetes mellitus
- Patients with suspected or diagnosed psychological/psychiatric problems that could
compromise the reliability of their results
- Lumbar spondylolisthesis on flexion/extension x-rays > 3 mm
- History of lumbar spine fractures (new or old)
- Any concurrent medical condition that may interfere with the interpretation of
efficacy and safety data during the study
- Autoimmune diseases
- Age less than 18 or greater than 75 years
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Low Back Pain
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Recurrent Lumbar Disc Herniation
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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