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Dynesys Spinal System Post Market 522 Study

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: NCT01528072
Recruitment Status : Terminated (Terminated at request of FDA)
First Posted : February 7, 2012
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Tracking Information
First Submitted Date  ICMJE February 2, 2012
First Posted Date  ICMJE February 7, 2012
Last Update Posted Date January 24, 2019
Study Start Date  ICMJE March 2012
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
Fusion rates (fused or not fused) at all treated levels of spine. [ Time Frame: 24 months post surgery date ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01528072 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
Safety Endpoints and Evaluation [ Time Frame: 24-month ]
Subjects will be clinically evaluated for adverse experiences and functional outcomes over the course of 24 months
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
Safety Endpoints and Evaluation [ Time Frame: over a 24 month time frame ]
Subjects will be clinically evaluated for adverse experiences and functional outcomes over the course of 24 months.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dynesys Spinal System Post Market 522 Study
Official Title  ICMJE Post Market Surveillance for the Dynesys Spinal System, Assessing Safety and Fusion.
Brief Summary The purpose of this study is to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System used as an adjunct to fusion and compare to literature control.
Detailed Description Study is meant to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Degenerative Spondylolisthesis
  • Pseudoarthrosis
Intervention  ICMJE Device: Dynesys Spinal System
Dynesys Spinal System will be used for all subjects
Study Arms  ICMJE Experimental: Dynesys System
All patients will receive the Dynesys System and all patients will be compared to historical literature control. Dynesys Spinal System will be used for all subjects.
Intervention: Device: Dynesys Spinal 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: January 22, 2019)
156
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2012)
168
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Skeletally mature between the ages of 20-80
  2. Candidate for posterior lateral fusion between T1-S1 with autograft
  3. Degenerative spondylolisthesis with evidence of neurologic impairment or failed previous fusion (pseudoarthrosis)
  4. Symptoms of leg and/or back pain
  5. Non-responsive to conservative/non-surgical treatment for at least three (3) months
  6. Must be willing and able to comply with study requirements; including complete necessary study paperwork and return for required follow-up visits

Exclusion Criteria:

  1. Active systemic or local infection
  2. Obesity
  3. Use of interbody device
  4. Pregnancy
  5. Mental illness
  6. Incarceration
  7. Alcohol or drug abuse
  8. Severe osteoporosis or osteopenia
  9. Use in the cervical spine
  10. Sensitivities/allergy to metals, polymers, polyethylene, polycarbonate urethane and polyethylene terephthalate
  11. Soft tissue deficit not allowing sound closure
  12. Any medical or physical condition that would preclude the potential benefit of spinal implant surgery
  13. Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device
  14. Active malignancy or other significant medical comorbidities
  15. Any medical or mental condition which would put the patient at high risk due to the severity of surgery
  16. Inadequate pedicles of the thoracic, lumbar and sacral vertebrae
  17. Patient unwilling or unable to follow postoperative instructions
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 NCT01528072
Other Study ID Numbers  ICMJE CMU2010-10S
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Zimmer Biomet
Study Sponsor  ICMJE Zimmer Biomet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Joel Batts Zimmer Biomet Spine
PRS Account Zimmer Biomet
Verification Date January 2019

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