- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00444405
Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation
February 25, 2020 updated by: Michelle McFarland, MPH, CHRC, Mercy Research
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.
Study Overview
Status
Withdrawn
Conditions
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 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.
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients with recurrent lumbar disc herniation.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alan M. Scarrow, MD, JD, St. John's Health System, Missouri
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
March 6, 2007
First Submitted That Met QC Criteria
March 6, 2007
First Posted (Estimate)
March 7, 2007
Study Record Updates
Last Update Posted (Actual)
February 27, 2020
Last Update Submitted That Met QC Criteria
February 25, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SJCNS-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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