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Clinical Trials/NCT00444405
NCT00444405
Withdrawn
Not Applicable

Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation

Mercy Research0 sitesMarch 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Mercy Research
Status
Withdrawn
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 2007
End Date
April 2009
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michelle McFarland, MPH, CHRC

Manager - Mercy Research

Mercy Research

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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