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A Clinical Study of the Dynesys(R) Spinal System

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: NCT00759057
Recruitment Status : Terminated (PMA not approved. FDA granted permission to close the study.)
First Posted : September 25, 2008
Last Update Posted : June 28, 2012
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Tracking Information
First Submitted Date  ICMJE September 23, 2008
First Posted Date  ICMJE September 25, 2008
Last Update Posted Date June 28, 2012
Study Start Date  ICMJE March 2003
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2008)
Overall Clinical Success (VAS Leg Pain, ODI, Major Complications, Additional Surgical Procedures, Neurological Status) [ Time Frame: 24 Months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00759057 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2008)
Radiographic Success, SF-12, Back Pain, Economic and Function Assessment, Subject Perception [ Time Frame: 24 Months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study of the Dynesys(R) Spinal System
Official Title  ICMJE A Clinical Study of the Dynesys(R) Spinal System As a Non-fusion Device for Spinal Stabilization
Brief Summary This non-inferiority study will compare the clinical outcomes of subjects implanted with the Dynesys Spinal System versus the clinical outcomes of subjects implanted with an instrumented posterior lateral spinal fusion.
Detailed Description The purpose of this clinical study is to demonstrate the safety and effectiveness of the Dynesys Spinal System for patients requiring one or contiguous two-level posterior spinal stabilization of the lumbar, and/or sacral spine following decompression. The ability for this implant to maintain spinal alignment and non-fusion of spinal segments, while positively affecting clinical outcomes, will be assessed and compared to a posterior lateral spinal fusion (PLF) procedure using autogenous bone with a semi-rigid, polyaxial posterior spinal fixation system.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Degenerative Spondylolisthesis or Retrolisthesis
  • Spinal Stenosis
  • Stenosing Lesion.
Intervention  ICMJE Device: Posterior Pedicle Screw System
Implantation of Posterior Pedicle Screw System
Study Arms  ICMJE
  • Experimental: 1 - Investigational
    Dynesys Non-Fusion Spinal System
    Intervention: Device: Posterior Pedicle Screw System
  • Active Comparator: 2 - Control
    Silhouette Posterior Pedicle Screw System as an adjunct to Posterior Lateral Fusion with Autograft.
    Intervention: Device: Posterior Pedicle Screw System
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: September 23, 2008)
399
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients having degenerative spondylolisthesis or retrolisthesis (up to Grade 1) AND/OR Patients having lateral or central spinal stenosis or other stenosing lesion as diagnosed by radiculopathic signs, neurogenic claudication or imaging studies;
  • Candidate for single-level or contiguous two-level PLF between L1-S1;
  • Patients have a predominate component of leg rather than back symptoms; symptoms include pain, muscle weakness, and/or sensation abnormality as evidenced by patient history and diagnostic studies.
  • Patients may require decompression at the levels considered for treatment
  • Pre-operative leg pain score greater than or equal to 40 mm on a 100 mm Visual Analog Scale (VAS);
  • Leg pain must be unresponsive to conservative (non-surgical) management for minimum of 3 months;
  • Pre-operative Oswestry score greater than or equal to 30 indicating at least moderate disability;
  • Skeletally mature individual between ages 20 and 80;
  • Must be willing and able to comply with study requirements; including willing and able to sign a study-specific, IRB-approved informed consent form, complete necessary study paperwork and return for required follow-up visits.

Exclusion Criteria:

  • Primary diagnosis of discogenic back pain at affected levels as evidenced by a larger back than leg pain component. In the event of multi-level pathology a discogram should be considered;
  • Patients with leg pain due to etiologies other than those listed above, such as trauma, peripheral vascular disease and neuropathy should be excluded;
  • Degenerative scoliosis greater than 10 degrees at the affected motion segment;
  • Supplemental interbody column support (e.g., bone graft, spacers or fusion cages) is planned at the affected level(s);
  • Greater than Grade I spondylolisthesis or retrolisthesis at the affected level(s);
  • Radiculopathic signs from more than two contiguous or two noncontiguous vertebral body segment(s);
  • Previous lumbar fusion attempt(s), previous total facetectomy or trauma at the affected level(s);
  • Gross obesity defined as exceeding ideal weight by greater than 40% (measurement details are given in Appendix A);
  • Active local or systemic infection;
  • Advanced osteoporosis as evidenced by plain film radiographs or history of fractures and confirmed by DEXA scan to confirm adequate bone density;
  • Receiving immunosuppressive or long-term steroid therapy;
  • Active hepatitis (viral or serum) or HIV positive, renal failure, systemic lupus erythematosus, or any other significant medical conditions which would substantially increase the risk of surgery;
  • Documented history of titanium alloy, PET or PCU allergy, or intolerance;
  • Active malignancy or other significant medical comorbidities;
  • Current chemical dependency or significant emotional and/or psychosocial disturbance that may impact treatment outcome or study participation as evidenced by three or more positive Waddell Signs;
  • Pregnancy;
  • Incarceration;
  • Severe muscular, neural or vascular diseases that endanger the spinal column;
  • Missing bone structures, due to severely deformed anatomy or congenital anomalies, which make good anchorage of the implant impossible;
  • All concomitant diseases that can jeopardize the functioning and success of the patient;
  • Vertebral fractures;
  • Treatment of the thoracic and cervical spine;
  • Severely deformed anatomy due to congenital anomalies;
  • Paralysis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 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 NCT00759057
Other Study ID Numbers  ICMJE G020291
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zimmer Biomet
Study Sponsor  ICMJE Zimmer Biomet
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zimmer Biomet
Verification Date June 2012

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