Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00444405
Recruitment Status : Withdrawn (PI left Health System)
First Posted : March 7, 2007
Last Update Posted : March 26, 2018
Information provided by (Responsible Party):
Tracy Haertling, DO, MS, Mercy Research

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.

Condition or disease
Low Back Pain Recurrent Lumbar Disc Herniation

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
Actual Enrollment : 0 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation
Study Start Date : March 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with recurrent lumbar disc herniation.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00444405

Sponsors and Collaborators
Mercy Research
Principal Investigator: Alan M. Scarrow, MD, JD St. John's Health System, Missouri

Responsible Party: Tracy Haertling, DO, MS, Manager - Investigator Initiated Trials, Mercy Research Identifier: NCT00444405     History of Changes
Other Study ID Numbers: SJCNS-01
First Posted: March 7, 2007    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018

Keywords provided by Tracy Haertling, DO, MS, Mercy Research:

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathological Conditions, Anatomical