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.

Study Overview

• Status: Withdrawn
• Conditions: Low Back Pain; Recurrent Lumbar Disc Herniation

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with recurrent lumbar disc herniation.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: Mercy Research
• Investigators: Principal Investigator: Alan M. Scarrow, MD, JD, St. John's Health System, Missouri

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: March 6, 2007
• First Submitted That Met QC Criteria: March 6, 2007
• First Posted (Estimate): March 7, 2007

Study Record Updates

• Last Update Posted (Actual): February 27, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: spine; lumbar; fusion; discectomy; disc; herniation
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Back Pain; Low Back Pain; Hernia; Recurrence; Intervertebral Disc Displacement
• Other Study ID Numbers: SJCNS-01