Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation

NCT00444405 | Withdrawn DMC

• 1 other identifier: SJCNS-01
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain; Recurrent Lumbar Disc Herniation

Keywords

lumbar; disc; herniation; discectomy; fusion; spine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with recurrent lumbar disc herniation.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mercy Research: lead

MeSH Terms

Conditions

Low Back Pain; Intervertebral Disc Displacement; Hernia

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical

Study Officials

• Alan M. Scarrow, MD, JD

  St. John's Health System, Missouri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager - Mercy Research

Study Record Dates

• First Submitted: March 6, 2007
• First Posted: March 7, 2007
• Study Start: March 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: February 27, 2020

Record last verified: 2020-02