Low Back PainNCT00444405
Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation
An observational study of Low Back Pain and Recurrent Lumbar Disc Herniation, run by Mercy Research.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain, Recurrent Lumbar Disc Herniation
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with recurrent lumbar disc herniation.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
About this study
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.
Read the 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.
- Conditions
- Low Back Pain, Recurrent Lumbar Disc Herniation
- Keywords
- lumbar, disc, herniation, discectomy, fusion, spine
- Medical subject headings
- Low Back Pain, Intervertebral Disc Displacement, Hernia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: PI left Health System
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle McFarland, MPH, CHRC, Mercy Research
- Investigators
- Alan M. Scarrow, MD, JD, Principal investigator, St. John's Health System, Missouri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444405
- Sponsor's protocol ID
- SJCNS-01
- Status last verified
- Feb 2020
- First submitted
- 6 Mar 2007
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT00444405
- Acronym / sponsor ID
- SJCNS-01
- Conditions
- Low Back Pain, Recurrent Lumbar Disc Herniation
- Keywords
- lumbar, disc, herniation, discectomy, fusion, spine
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI left Health System
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mercy ResearchUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 7 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with recurrent lumbar disc herniation.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan M. Scarrow, MD, JD principal investigator
St. John's Health System, Missouri
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Recurrent Lumbar Disc Herniation, run by Mercy Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020.