Status:
WITHDRAWN
Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation
Lead Sponsor:
Mercy Research
Conditions:
Low Back Pain
Recurrent Lumbar Disc Herniation
Eligibility:
All Genders
18-75 years
Brief Summary
The purpose of this study is to compare patients who underwent decompression/discectomy with pedicle screw fusion to patients who received decompression/discectomy without fusion.
Detailed Description
Lumbar disc herniations are quite common and typically improve after surgical correction. However, some patients develop recurrent herniations at the same level. Controversy exists as to why reherniat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00444405
Start Date
March 1 2007
End Date
April 1 2009
Last Update
February 27 2020
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