Wallis Stabilization System for Low Back Pain

Low Back Pain Clinical Trial

Official title:

A Prospective, Multi-center, Randomized, Active-Controlled Study of the Wallis System for the Treatment of Mild to Moderate Degenerative Disc Disease of the Lumbar Spine

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00484458
• Other study ID #: 6000-1006-P1-R1
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 7, 2007
• Last updated: October 3, 2011
• Start date: January 2007
• Est. completion date: November 2014

Study information

• Verified date: October 2011
• Source: Zimmer Spine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate that the Wallis System (interspinous process implant) is equivalent to total disc replacement (TDR) for the treatment of mild to moderate degenerative disc disease (DDD) of the lumbar spine at the L4-L5 level.

This study will assess the safety and efficacy of the Wallis® System compared to commercially available lumbar TDR with respect to individual subject success rates at 24 months postoperative follow-up.

Study participants will receive all study related test articles and surgical procedures at no charge. Please scroll down to the "Locations" section to find a doctor in your area that is participating in this study. If you are interested in participating in this study and do not see a doctor in your area, please contact Jose Naveira at jose.naveira@abbottspine.com

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 340
• Est. completion date: November 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age 18-60 (inclusive) and skeletally mature.

• Diagnosis of mild to moderate DDD at L4-L5 as confirmed by radiography.

• Minimum of six months of failed conservative treatment.

• Pre-operative visual analog (VAS) low back pain score = 40, on a scale of 100mm, with low back pain greater than left or right leg pain.

• Preoperative baseline Oswestry Disability Index (ODI) score of = 40 on a 100 point scale.

• Physically and mentally able to comply with the protocol, including ability to read and complete required forms, and willing and able to adhere to the follow-up requirements of the protocol.

• Voluntarily signs the patient informed consent form.

• Patient is a surgical candidate for an anterior approach to the lumbar spine (< 3 abdominal surgeries).

Exclusion Criteria:

• The investigator believes that the L1-L2, L2-L3, L3-L4, or L5-S1 level is symptomatic based upon objective evidence, e.g., radiograph, MRI, or discography.

• Evidence of a prior fracture or trauma to the vertebral bodies at the affected level and/or the spinous processes at the L4-L5 or adjacent levels.

• Osteoporosis or osteopenia or metabolic bone disease as confirmed by DEXA scan (T score < -1.0). Female subjects older than 45 years of age (or post-menopausal women, history of oophorectomy, or family history of osteoporosis) and male subjects older than 55 years will undergo a pre-operative, dual energy x-ray absorptiometry (DEXA) of the lumbar spine. The DEXA will be used to identify subjects with an indication of osteoporosis, osteopenia or metabolic bone disease. Subjects with a T-score of less than -1.0 will be excluded from the study.

• Congenital lumbar spinal stenosis.

• Bony lumbar stenosis.

• Extreme obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines Body Mass Index (BMI > 40kg/m2).

• A history of any surgical procedure intended to remove or alter the disc (e.g. discectomy, intradiscal electrothermal therapy (IDET) or enzymes), decompress (laminectomy) or fuse, either the index or adjacent levels.

• Prior participation in study of any investigational spinal implant or investigational spinal treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Intervertebral Disc Degeneration
• Low Back Pain

Intervention

Device:
• Interspinous process and dynamic stabilization (Wallis System)
Interspinous stabilization
• Total Disc Replacement
Total disc

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Spine Source	Beverly Hills	California
United States	Boulder Neurosurgical Associates	Boulder	Colorado
United States	Medical University of South Carolina	Charleston	North Carolina
United States	Triangle Orthopaedic Associates, P.A.	Durham	North Carolina
United States	Core Orthopaedic Medical Center	Encinitas	California
United States	Fort Wayne Orthopaedics	Fort Wayne	Indiana
United States	Aurora BayCare Medical Center	Green Bay	Wisconsin
United States	Denver Spine	Greenwood Village	Colorado
United States	Illinois Bone & Joint Institute	Morton Grove	Illinois
United States	University of Utah-Dept. of Neurosurgery-Dept. of Orthopedic Surgery	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Zimmer Spine	Zimmer, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-inferior to commercially available lumber TDR after 24 months.		24 months	Yes