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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00878579
Recruitment Status : Terminated (Sponsor Termination)
First Posted : April 9, 2009
Last Update Posted : February 21, 2013
Sponsor:
Information provided by (Responsible Party):
Interventional Spine, Inc.

Tracking Information
First Submitted Date  ICMJE April 7, 2009
First Posted Date  ICMJE April 9, 2009
Last Update Posted Date February 21, 2013
Study Start Date  ICMJE March 2009
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2009)
Improvement in Oswestry Disability Index (ODI) [ Time Frame: 2 Years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Percutaneous Dynamic Stabilization (PDS) System Versus Fusion for Treating Degenerative Disc Disease
Official Title  ICMJE A Study to Evaluate the Safety and Effectiveness of the PDS System to Treat Back Pain Associated With Degenerative Disc Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lumbar Degenerative Disc Disease
Intervention  ICMJE
  • Device: PDS System
    Percutaneous Dynamic Stabilization System
  • Device: Fusion
    Transforaminal Interbody Fusion (TLIF) with Autograft and Pedicle Screws
Study Arms  ICMJE
  • Experimental: PDS System
    Intervention: Device: PDS System
  • Active Comparator: Fusion
    Intervention: Device: Fusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 19, 2013)
20
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2009)
292
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00878579
Other Study ID Numbers  ICMJE PDS-002-DDD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Interventional Spine, Inc.
Study Sponsor  ICMJE Interventional Spine, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Interventional Spine, Inc.
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP