Text Size

Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Zimmer, Inc.
Information provided by (Responsible Party):
Layla Stanek, St. John's Health System, Missouri
ClinicalTrials.gov Identifier:
NCT00444405
First received: March 6, 2007
Last updated: October 12, 2011
Last verified: October 2011
History of Changes

March 6, 2007
October 12, 2011
March 2007
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00444405 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation
Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation

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.

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.
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Adult patients with recurrent lumbar disc herniation.
  • Low Back Pain
  • Recurrent Lumbar Disc Herniation
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
4
April 2009
Not Provided

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00444405
SJCNS-01
Yes
Layla Stanek, St. John's Health System, Missouri
St. John's Health System, Missouri
Zimmer, Inc.
Principal Investigator: Alan M. Scarrow, MD, JD St. John's Health System, Missouri
St. John's Health System, Missouri
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP