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Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation

This study is currently recruiting participants.
Verified by St. John's Health System, March 2007

Sponsors and Collaborators: St. John's Health System
Zimmer, Inc.
Information provided by: St. John's Health System
ClinicalTrials.gov Identifier: NCT00444405
  Purpose

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 Intervention Phase
Low Back Pain
Recurrent Lumbar Disc Herniation
Procedure: Repeat lumbar disc decompression/discectomy
Procedure: Repeat decompression/discectomy with pedicle screw fusion
Phase IV

MedlinePlus related topics:   Back Pain    Hernia   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Longitudinal, Defined Population, Prospective Study
Official Title:   Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation

Further study details as provided by St. John's Health System:

Estimated Enrollment:   50
Study Start Date:   March 2007

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.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  • Autoimmune diseases
  • Age less than 18 or greater than 75 years
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444405

Contacts
Contact: Layla R. Stanek, MS     (417) 841-0247     layla.stanek@mercy.net    

Locations
United States, Missouri
The Spine Center--St. John's Clinic     Recruiting
      Springfield, Missouri, United States, 65804
      Contact: Pete J. Miles, BSN     417-841-0250     pete.miles@mercy.net    
      Principal Investigator: Alan M. Scarrow, MD, JD            

Sponsors and Collaborators
St. John's Health System
Zimmer, Inc.

Investigators
Principal Investigator:     Alan M. Scarrow, MD, JD     St. John's Health System    
  More Information


Study ID Numbers:   SJCNS-01
First Received:   March 6, 2007
Last Updated:   March 6, 2007
ClinicalTrials.gov Identifier:   NCT00444405
Health Authority:   United States: Institutional Review Board

Keywords provided by St. John's Health System:
lumbar  
disc  
herniation  
discectomy
fusion
spine

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Signs and Symptoms
Hernia
Neurologic Manifestations
Low Back Pain
Pain
Back Pain
Recurrence

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Nervous System Diseases

ClinicalTrials.gov processed this record on October 31, 2008




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