Percutaneous Dynamic Stabilization (PDS) System Versus Fusion for Treating Degenerative Disc Disease

NCT00878579 | Terminated Phase 2

• 1 other identifier: PDS-002-DDD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of the PDS System compared to the surgical control of posterolateral fusion with autograft and pedicle screw fixation for the treatment of one or two levels from L3-S1 to relieve back pain associated with degenerative disc disease.

Conditions

Lumbar Degenerative Disc Disease

Keywords

back pain; Spine; Spinal; Lower back pain; Lumbar; Lumbar Pain; DDD; Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• Improvement in Oswestry Disability Index (ODI)

  2 Years

Study Arms (2)

PDS System

EXPERIMENTAL

Device: PDS System

Fusion

ACTIVE COMPARATOR

Device: Fusion

Interventions

PDS System DEVICE

Percutaneous Dynamic Stabilization System

PDS System

Fusion DEVICE

Transforaminal Interbody Fusion (TLIF) with Autograft and Pedicle Screws

Fusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmation of DDD (back pain with degeneration of the disc by patient history, physical exam, and radiographic studies and with one or more of the following factors:
• Osteophyte formation of facet joints or vertebral endplates
• Facet joint degeneration (no more than mild to moderate)
• Subjects with ≤50% collapse of disc as compared to the adjacent level
• Subjects with or without a contained herniated nucleus pulposus \<5 mm and no free fragment
• Skeletally mature subjects aged between 18 and 70 years of age inclusive.
• Subjects with primarily back pain associated with degenerative disc disease of the lumbar spine at one level or two adjacent levels from L3 through S1. Subjects may have a lesser degree of leg pain at the same level(s).
• Subjects who require surgical or minimally invasive intervention, who have failed to adequately improve following 6 months of non-operative therapy.
• Subject is a surgical candidate for a posterior approach to the lumbar spine and is suitable for fusion using pedicle screw systems
• Subjects with a minimum baseline Oswestry Score of 40% (20/50).
• Subjects with a minimum baseline VAS Score of 40/100 mm.
• MRI diagnostic for DDD within 3 months of the screening visit.
• Subjects who are mentally, physically and psychosocially able to cooperate with the study procedures and return for all required follow-up visits.
• Subjects who are able to understand this study and have given voluntary, written informed consent to participate in this study.

You may not qualify if:

• Subjects who have leg pain greater than back pain.
• Subjects with severe facet degeneration, radiographic findings of severe facet joint disease, degeneration or misshapen facet(s) or structural anomalies at the target level(s) that would preclude placement of the PDS device or pedicle screw systems.
• Subjects who require a pedicle screw smaller than 4.5 mm.
• Subjects with Modic 3 bone changes at the target level(s).
• Spondylolisthesis \> Grade 1 and/or spondylolysis at the target level(s).
• Subjects with myelopathy or cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (retention or incontinence).
• Subjects with fixed motor deficit and/or peripheral neuropathy.
• Subjects with prior discectomy at the target level(s).
• Subjects with prior spine surgery, trauma, metastatic disease, or spinal deformity due to scoliosis (Cobb angle \> 15 degrees) or kyphosis (\> 11 degrees) at any lumbar level.
• Subjects who have used any investigational drug or device within the past 30 days or have had an experimental spinal implant at any time.
• Subjects with active local or systemic infection.
• Subjects with metabolic bone disease (e.g. osteomalacia, Paget's disease).
• Subjects with rheumatoid arthritis or other autoimmune spondyloarthropathies.
• Subjects with a systemic disease that compromises life expectancy (e.g. HIV, AIDS, hepatitis) or are on immuno-suppressive agents.
• Subjects who are taking any drug known to potentially interfere with bony/soft tissue healing, (e.g., steroids at any dose daily within the last 12 months).

Sponsors & Collaborators

• Interventional Spine, Inc.: lead

Study Sites (2)

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Willow Grove, Pennsylvania, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Back Pain; Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2009
• First Posted: April 9, 2009
• Study Start: March 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 21, 2013

Record last verified: 2013-02

Locations

US (2)