Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 6, 2007

Last Updated Date

March 6, 2007

Start Date ^†

March 2007

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation

Official Title ^†

Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation

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.

Study Phase

Phase IV

Study Type ^†

Observational

Study Design ^†

Longitudinal, Defined Population, Prospective Study

Condition ^†

Low Back Pain
Recurrent Lumbar Disc Herniation

Intervention ^†

Procedure: Repeat lumbar disc decompression/discectomy
Procedure: Repeat decompression/discectomy with pedicle screw fusion

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Primary Completion Date

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
Autoimmune diseases
Age less than 18 or greater than 75 years

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Layla R. Stanek, MS

(417) 841-0247

layla.stanek@mercy.net

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00444405

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

St. John's Health System

Collaborators ^††

Zimmer, Inc.

Investigators ^†

Principal Investigator:

Alan M. Scarrow, MD, JD

St. John's Health System

Information Provided By

St. John's Health System

Verification Date

March 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.