Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation
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ClinicalTrials.gov Identifier: NCT00444405
Recruitment Status :
(PI left Health System)
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.
Condition or disease
Low Back PainRecurrent Lumbar Disc Herniation
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 reherniated discs occur. Moreover, existing research does not settle the issue of whether a second decompression/discectomy or a repeat decompression/discectomy with pedicle screw fusion is the more successful treatment. This study is designed to compare differences in patient-reported pain, physical function, and satisfaction between the two types of surgery patients.
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adult patients with recurrent lumbar disc herniation.
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
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
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