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

This study has been terminated.
(Sponsor Termination)
Sponsor:
Information provided by (Responsible Party):
Interventional Spine, Inc.
ClinicalTrials.gov Identifier:
NCT00878579
First received: April 7, 2009
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Lumbar Degenerative Disc Disease
Device: PDS System
Device: Fusion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Safety and Effectiveness of the PDS System to Treat Back Pain Associated With Degenerative Disc Disease

Resource links provided by NLM:


Further study details as provided by Interventional Spine, Inc.:

Primary Outcome Measures:
  • Improvement in Oswestry Disability Index (ODI) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: March 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PDS System Device: PDS System
Percutaneous Dynamic Stabilization System
Active Comparator: Fusion Device: Fusion
Transforaminal Interbody Fusion (TLIF) with Autograft and Pedicle Screws

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Skeletally mature subjects aged between 18 and 70 years of age inclusive.
  3. 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).
  4. Subjects who require surgical or minimally invasive intervention, who have failed to adequately improve following 6 months of non-operative therapy.
  5. Subject is a surgical candidate for a posterior approach to the lumbar spine and is suitable for fusion using pedicle screw systems
  6. Subjects with a minimum baseline Oswestry Score of 40% (20/50).
  7. Subjects with a minimum baseline VAS Score of 40/100 mm.
  8. MRI diagnostic for DDD within 3 months of the screening visit.
  9. Subjects who are mentally, physically and psychosocially able to cooperate with the study procedures and return for all required follow-up visits.
  10. Subjects who are able to understand this study and have given voluntary, written informed consent to participate in this study.

Exclusion Criteria:

  1. Subjects who have leg pain greater than back pain.
  2. 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.
  3. Subjects who require a pedicle screw smaller than 4.5 mm.
  4. Subjects with Modic 3 bone changes at the target level(s).
  5. Spondylolisthesis > Grade 1 and/or spondylolysis at the target level(s).
  6. Subjects with myelopathy or cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (retention or incontinence).
  7. Subjects with fixed motor deficit and/or peripheral neuropathy.
  8. Subjects with prior discectomy at the target level(s).
  9. 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.
  10. Subjects who have used any investigational drug or device within the past 30 days or have had an experimental spinal implant at any time.
  11. Subjects with active local or systemic infection.
  12. Subjects with osteoporosis. A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen subjects. If DEXA is required, exclusion will be defined as a DEXA bone density measured T scored < -1.0.
  13. Subjects with metabolic bone disease (e.g. osteomalacia, Paget's disease).
  14. Subjects with rheumatoid arthritis or other autoimmune spondyloarthropathies.
  15. Subjects with a systemic disease that compromises life expectancy (e.g. HIV, AIDS, hepatitis) or are on immuno-suppressive agents.
  16. 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).
  17. Subjects with active malignancy: A subject with a history of any invasive malignancy (except non-melanoma skin cancer), unless s/he has been treated with curative intent and there have been no clinical signs or symptoms of malignancy for at least 5 years.
  18. Subjects with a known allergy to titanium and/or polycarbonate urethane (PCU).
  19. Subjects who have existing conditions or pending litigation claims that could compromise their participation, follow-up care, or treatment outcomes (e.g., drug or alcohol abuse).
  20. Subjects with a BMI of ≥ 40 kg/m2 or weight > 275 pounds (125 kg).
  21. Subjects who are pregnant or are planning a pregnancy during the study period.
  22. Subjects who are prisoners.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878579

Locations
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Willow Grove, Pennsylvania, United States
Sponsors and Collaborators
Interventional Spine, Inc.
  More Information

No publications provided

Responsible Party: Interventional Spine, Inc.
ClinicalTrials.gov Identifier: NCT00878579     History of Changes
Other Study ID Numbers: PDS-002-DDD
Study First Received: April 7, 2009
Last Updated: February 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Interventional Spine, Inc.:
back pain
Spine
Spinal
Lower back pain
Lumbar
Lumbar Pain
DDD
Degenerative Disc Disease

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disk Degeneration
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 20, 2014