Dynesys Spinal System Post Market 522 Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Zimmer, Inc.
Sponsor:
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT01528072
First received: February 2, 2012
Last updated: March 26, 2014
Last verified: March 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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, Inc.:

Primary Outcome Measures:
  • Fusion rates (fused or not fused) at all treated levels of spine. [ Time Frame: 24 months post surgery date ] [ Designated as safety issue: No ]
  • Safety Endpoints and Evaluation [ Time Frame: 24-month ] [ Designated as safety issue: Yes ]
    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: March 2016
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dynesys System
All patients will receive the Dynesys System and all patients will be compared to historical literature control.
Device: Dynesys Spinal System
Dynesys Spinal System will be used for all subjects

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528072

Contacts
Contact: Laura Herdrich 952-830-6224 laura.herdrich@zimmer.com
Contact: Joe Murar, M.D. 952-836-8534 joe.murar@zimmer.com

Locations
United States, Illinois
Neurological Surgery of Southern Ill Recruiting
Belleville, Illinois, United States, 62226
Contact: Sandy Reith, NP    618-233-3330    smreith@gmail.com   
Contact: Elizabeth Wallace, RN    618-233-3330    ewallace@memorialmedgroup.com   
Principal Investigator: William Sprich, M.D.         
United States, Maryland
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: Robin Perry, RN    443-849-4282    RPERRY@gbmc.org   
Principal Investigator: Reginald Davis, M.D.         
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, 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 Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Marie Kerr    215-829-6720    marie.kerr@upenn.edu   
Principal Investigator: William Sprich, MD         
Allegheny General Hospital Recruiting
Pittsburg, Pennsylvania, United States, 15212
Contact: Diane Cantella    412-359-3353    dcantell@wpahs.com   
Principal Investigator: Donald Whiting, MD         
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, Inc.
  More Information

No publications provided

Responsible Party: Zimmer, Inc.
ClinicalTrials.gov Identifier: NCT01528072     History of Changes
Other Study ID Numbers: CMU2010-10S
Study First Received: February 2, 2012
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Zimmer, Inc.:
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

ClinicalTrials.gov processed this record on October 16, 2014