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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

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.

Condition or disease Intervention/treatment Phase
Degenerative Spondylolisthesis Pseudoarthrosis Device: Dynesys Spinal System Not Applicable

Detailed Description:
Study is meant to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post Market Surveillance for the Dynesys Spinal System, Assessing Safety and Fusion.
Study Start Date : March 2012
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Arm Intervention/treatment
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.
Device: Dynesys Spinal System
Dynesys Spinal System will be used for all subjects




Primary Outcome Measures :
  1. Fusion rates (fused or not fused) at all treated levels of spine. [ Time Frame: 24 months post surgery date ]

Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528072


Locations
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United States, Illinois
Neurological Surgery of Southern Ill
Belleville, Illinois, United States, 62226
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Pine Heights Medical Center
Baltimore, Maryland, United States, 21229
United States, New York
NYU - Center for Musculoskeletal Care
New York, New York, United States, 10003
United States, Ohio
Riverhills Healthcare, Inc
Cincinnati, Ohio, United States, 45242
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19106
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
OrthopaediCare
Willow Grove, Pennsylvania, United States, 19090
United States, Virginia
Danville Orthopedics and Spine
Danville, Virginia, United States, 24541
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Joel Batts Zimmer Biomet Spine

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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01528072     History of Changes
Other Study ID Numbers: CMU2010-10S
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Zimmer Biomet:
Dynesys Dynamic Stabilization System
Spondylolithesis
pseudoarthrosis
neurologic impairment
failed fusion

Additional relevant MeSH terms:
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Spondylolisthesis
Pseudarthrosis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Fractures, Ununited
Fractures, Bone
Wounds and Injuries