Dynamic Stabilization for Lumbar Spinal Stenosis With Stabilimax NZ® Dynamic Spine Stabilization System

NCT00529997 | Terminated DMC

• 1 other identifier: AST-A-01
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 19

Brief Summary

The purpose of this trial is to assess whether the Stabilimax NZ® is at least as safe and effective as the control therapy of fusion in patients receiving decompression surgery for the treatment of clinically symptomatic spinal stenosis at one contiguous vertebral levels from L1-S1. Safety and effectiveness will be assessed by means of primary study endpoints which address improvements in pain and function in the absence of major device related complications. The study hypothesis criteria for demonstrating safety and efficacy requires scientific evidence that patients classified as satisfying the primary study endpoint post device implantation is at least as good for Stabilimax NZ® recipients as that for patients undergoing fusion with posterior pedicle screw instrumentation at the 24 month followup assessment.

Conditions

Lumbar Spinal Stenosis

Keywords

Lumbar Spine; Lumbar Spinal Stenosis; Spondylolisthesis; Dynamic Stabilization; Motion Preserving; Arthroplasty; Randomized; Investigational; Back Pain; Leg Pain

Outcome Measures

Primary Outcomes (1)

• Decrease in leg pain of 20 mm on a VAS pain scale; Decrease of ≥ .5 on ZCQ for both Symptom Severity and Physical Function; No major device-related complications; and No surgical revision, reoperation, removal, or supplemental fixation at treated level

  2 years

Secondary Outcomes (1)

• Reduction in OR Time, Blood Loss, Hospital Stay. Improvement in quality of life and return to work. Improvement in the incidence of adverse events. Radiographic evidence of nonfusion.

  2 years

Study Arms (2)

1

EXPERIMENTAL

Posterior Dynamic Stabilization with the Stabilimax NZ

Device: Stabilimax NZ® Dynamic Spine Stabilization System

2

ACTIVE COMPARATOR

Posteriolateral instrumented fusion

Device: Stabilimax NZ® Dynamic Spine Stabilization System

Interventions

Stabilimax NZ® Dynamic Spine Stabilization System DEVICE

Surgical Implantation

1; 2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiographic:
• Degenerative spinal stenosis of the lumbar spine, central, lateral recess, or foraminal;
• Evidence of the cal sac and/or cauda equina compression, nerve root impingement, hypertrophic facets with canal encroachment, with or without spondylolisthesis, if present, no more than grade 1
• General:
• The greater of the patients right and left VAS leg pain score is ≥ 40 mm on a 100 mm scale;
• Zurich Claudication Questionnaire Symptom Severity score greater than 2 on a scale of 1-5;
• Zurich Claudication Questionnaire Physical Function score greater than or equal to 2 on a scale of 1-4;
• Intermittent neurogenic claudication
• At least six months of non-surgical management.
• Skeletally mature patients at least 21 years of age;
• Willing to provide written consent for participation and a Health Insurance Portability and Accountability Act authorization;
• Willing to undergo all study procedures including physical therapy and adhere to the follow-up schedule; and
• No additional surgical treatment is required outside the investigational or control at the time of surgery.

You may not qualify if:

• Initial Screening:
• Prior surgery at any lumbar level including the level being treated except for: Lamino/Foraminotomy, Microdiscectomy, IDET, and Percutaneous Discectomy.
• Prior surgery at any lumbar level within one year of enrollment;
• No more than one prior surgery at any lumbar level;
• Previous acute trauma at the treated level within two years of enrollment;
• Primary and predominate diagnosis of discogenic back pain, e.g. torn disc, herniated disc inflamed or irritated disc, or other disc pathology;
• Symptomatic cervical and/or thoracic neurological compromise;
• Significant peripheral neuropathy or acute denervation secondary to radiculopathy, caused by conditions other than spinal stenosis;
• Other neurological pathology that could confound study results;
• Cauda Equina Syndrome;
• Contraindicated for MRI;
• Morbid obesity (BMI \> 40);
• Peripheral vascular disease requiring intervention (≥ 50% stenosis of vessel);
• Active systemic or surgical site infection;
• Any significant medical conditions that would represent a significant increase in surgical risk or interfere with normal healing;

Sponsors & Collaborators

• Applied Spine Technologies: lead

Study Sites (19)

Surgical Specialty Hospital

Phoenix, Arizona, 85015, United States

Location

Cedars Sinai Medical Center Hospital

Los Angeles, California, 90048, United States

Location

Tri-City Medical Center

Oceanside, California, 92056, United States

Location

Littleton Adventist Hospital

Littleton, Colorado, 80122, United States

Location

New Britain General Hospital

New Britain, Connecticut, 06052, United States

Location

Morton Plant Mease

Clearwater, Florida, 33756, United States

Location

Largo Medical Center

Largo, Florida, 33770, United States

Location

University Community Hospital at Carrolwood

Tampa, Florida, 33614, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Upstate Medical Center

Syracuse, New York, 13210, United States

Location

North Carolina Specialty Hospital

Durham, North Carolina, 27704, United States

Location

Blanchard Valley Hospital

Findlay, Ohio, 45840, United States

Location

Sacred Heart Medical Center

Eugene, Oregon, 97401, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18105, United States

Location

Wellmont Bristol Regional Medical Center

Bristol, Tennessee, 37620, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Presbyterian Plano Center for Diagnostics & Surgery

Plano, Texas, 75093, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

DePaul Medical Center

Norfolk, Virginia, 23505, United States

Location

MeSH Terms

Conditions

Spinal Stenosis; Spondylolisthesis; Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Guyer, MD

  Texas Back Institute

  PRINCIPAL INVESTIGATOR

• David Musante, M.D.

  Triangle Orthopedics Associates

  PRINCIPAL INVESTIGATOR

• Neel Anand, M.D.

  Cedars Sinai Medical Center Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 17, 2007
• Study Start: February 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 11, 2010

Record last verified: 2010-08

Locations

US (19)