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
Study 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:

Spinal Diseases
Pathological Conditions, Anatomical
Signs and Symptoms
Musculoskeletal Diseases
Hernia
Neurologic Manifestations

Low Back Pain
Pain
Intervertebral Disk Displacement
Bone Diseases
Back Pain
Recurrence

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009