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Dynesys Spinal System Post Market 522 Study

This study is currently recruiting participants.
Verified February 2016 by Zimmer Biomet
Sponsor:
ClinicalTrials.gov Identifier:
NCT01528072
First Posted: February 7, 2012
Last Update Posted: July 15, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Zimmer Biomet
  Purpose
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 Intervention
Degenerative Spondylolisthesis Pseudoarthrosis Device: Dynesys Spinal System

Study Type: Interventional
Study Design: 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.

Further study details as provided by Zimmer Biomet:

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

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 168
Study Start Date: March 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Kimberly Krugman 303-465-8928 kiimberly.krugman@zimmerbiomet.comt

Locations
United States, Illinois
Neurological Surgery of Southern Ill Terminated
Belleville, Illinois, United States, 62226
United States, Maryland
Greater Baltimore Medical Center Terminated
Baltimore, Maryland, United States, 21204
Pine Heights Medical Center Recruiting
Baltimore, Maryland, United States, 21229
Contact: Cynthia Ray    410-646-0220    hhschtd@hotmail.com   
Principal Investigator: Charles Schnee         
United States, New York
NYU - Center for Musculoskeletal Care Recruiting
New York, New York, United States, 10003
Contact: Elizabeth Tanzi    646-794-8643    elizabeth.tanzi@gmail.com   
Contact: Alex Lee    646-794-8643    alex.lee@nyumc.org   
Principal Investigator: Themistocles Propopsaltis         
Sub-Investigator: Schwab Frank         
Sub-Investigator: Errico Thomas         
United States, Ohio
Riverhills Healthcare, Inc Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Debbie Coughlin, RN    513-865-1148    deborah_coughlin@trihealth.com   
Principal Investigator: Jonathan Borden, M.D.         
United States, Pennsylvania
University of Pennsylvania Terminated
Philadelphia, Pennsylvania, United States, 19106
Allegheny General Hospital Recruiting
Pittsburg, Pennsylvania, United States, 15212
Contact: Diane Cantella    412-359-3353    dcantell@wpahs.com   
Principal Investigator: Donald Whiting, MD         
OrthopaediCare Recruiting
Willow Grove, Pennsylvania, United States, 19090
Contact: Barbara Finn    267-913-3121    bfinn@paortho.com   
Principal Investigator: Michael Gratch         
United States, Virginia
Danville Orthopedics and Spine Recruiting
Danville, Virginia, United States, 24541
Contact: April Marshall, RN, CCRC    434-793-4711 ext 349    marshalla@danvilleortho.com   
Principal Investigator: Leon Abram         
Sponsors and Collaborators
Zimmer Biomet
Investigators
Study Director: Joel Batts Zimmer Biomet Spine
  More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01528072     History of Changes
Other Study ID Numbers: CMU2010-10S
First Submitted: February 2, 2012
First Posted: February 7, 2012
Last Update Posted: July 15, 2016
Last Verified: February 2016
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:
Spondylolisthesis
Pseudarthrosis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Fractures, Ununited
Fractures, Bone
Wounds and Injuries