COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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. Identifier: NCT01528072
Recruitment Status : Terminated (Terminated at request of FDA)
First Posted : February 7, 2012
Results First Posted : January 29, 2020
Last Update Posted : January 29, 2020
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 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 [ Time Frame: 24 months post surgery date ]

    Fusion was defined by meeting three criteria:

    • rotation < 5° between motion segments on flexion-extension radiographs
    • translation < 3 mm between motion segments on flexion-extension radiographs
    • presence of bridging bone. Fusion assessment for each patient was categorized as one of the four defined outcomes: fused, not fused, partial fusion, or UA (unable to assess). Efficacy was confirmed by the achievement of fusion in the experimental group when compared to the rate established in a literature control.

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.

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

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 identifier (NCT number): NCT01528072

Layout table for location information
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
Willow Grove, Pennsylvania, United States, 19090
United States, Virginia
Danville Orthopedics and Spine
Danville, Virginia, United States, 24541
Sponsors and Collaborators
Zimmer Biomet
Layout table for investigator information
Study Director: Joel Batts Zimmer Biomet Spine
  Study Documents (Full-Text)

Documents provided by Zimmer Biomet:

Layout table for additonal information
Responsible Party: Zimmer Biomet Identifier: NCT01528072    
Other Study ID Numbers: CMU2010-10S
First Posted: February 7, 2012    Key Record Dates
Results First Posted: January 29, 2020
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Zimmer Biomet:
Dynesys Dynamic Stabilization System
neurologic impairment
failed fusion
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Fractures, Ununited
Fractures, Bone
Wounds and Injuries