Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation

NCT ID: NCT00444405

Last Updated: 2020-02-27

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-04-30

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.

Conditions

Low Back Pain; Recurrent Lumbar Disc Herniation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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

• 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

Exclusion Criteria

• Recurrence of disc herniation within 3 months of first decompression
• Multiple level herniated discs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mercy Research

OTHER

Sponsor Role: lead

Responsible Party

Michelle McFarland, MPH, CHRC

Manager - Mercy Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alan M. Scarrow, MD, JD

Role: PRINCIPAL_INVESTIGATOR

St. John's Health System, Missouri

Other Identifiers

SJCNS-01

Identifier Type: -

Identifier Source: org_study_id