Introduction
The Dynesys® Spinal System is an investigational device currently limited by US (Federal) law to investigational use in the US. The US Clinical Study of the Dynesys System is a multi-center prospective, randomized, controlled clinical trial comparing the safety and effectiveness of the Dynesys Spinal System to spinal fusion surgery.
The Dynesys system uses flexible materials to stabilize the affected lumbar region while preserving the natural anatomy of the spine. The system is designed to stabilize the spine without fusing.
Study objectives
The objective of this clinical investigation is to compare the safety and effectiveness of the Dynesys Spinal System to spinal fusion surgery in the treatment of lower back and leg pain that results from spinal stenosis and/or spondylolisthesis at one or two adjacent vertebral levels between L1 and S1.
Study overview
Approximately twenty centers will be enrolling patients into this study to assess the safety and effectiveness of the Dynesys Spinal System. This new treatment will be compared to the current standard treatment to see which is more successful.
This is a randomized trial where 67% of the patients will receive the Dynesys Spinal System and 33% will receive posterior lumbar fusion, a standard procedure utilizing a pedicle screw and autograft. Patients will be randomly assigned to receive either the Dynesys Spinal System or spinal fusion surgery.
Patients will be required to return to the clinic for periodic checkups for a minimum of 2 years.
Study sponsors
· Centerpulse Spine-Tech Inc. (d/b/a Zimmer Spine, Inc.)
Headquartered in Minneapolis, MN, Zimmer Spine researches, develops, and manufactures spinal implants and instrumentation. For more information about Zimmer Spine, visit www.zimmerspine.com.
Status
Recruiting
Participating sites and contact information
Please contact a hospital near you for additional information on participating in this clinical study.
California
Colorado
Georgia
Indiana
Louisiana
Maryland
Michigan
Minnesota
New York
North Carolina
Pennsylvania
South Carolina
Texas
More centers that are participating in this clinical trial will be added to this list shortly.
California:
Center:
The Spine Institute at St. John’s Health Center
Primary investigator:
Rick Delamarter, MD
Address:
1301 20th Street, Suite 400
Santa Monica, CA 90404
Coordinator contact:
Parveen Sra, M.P.H.
Phone:
310-828-7757
Fax:
310-828-6847
Website:
www.espineinstitute.com
Center:
Pacific Regional Neurosurgery Interventional Pain Medical Center
Primary investigator:
David B. Bybee, MD
Address:
1524 McHenry Ave. Suite 135
Modesto, CA 95350
Coordinator contact:
Diane Mellor
Phone:
209-571-0288
Fax:
209-571-0326
Email:
dianem@prnpain.com
Colorado:
Center:
Denver Spine Clinic
Primary investigator:
David Wong, MD
Address:
1601 E. 19th Avenue, Suite 4000
Denver, Colorado 80218
Coordinator contact:
Betsy Annesser
Phone:
303-563-3202
Fax:
303-839-7188
Website:
www.denvermicrospine.com
Georgia:
Center:
Northside Hospital
Primary investigator:
D. Hal Silcox, III, MD
Address:
5505 Peachtree Dunwoody Rd., Suite 600
Atlanta GA, 30342
Coordinator contact:
Anita Sharitt, MSHSA, RN, ONC
Phone:
404-425-1015
Fax:
404-943-0641
Website:
www.POCAtlantia.com
Indiana:
Center:
Fort Wayne Orthopedics
Primary investigator:
Kevin Rahn, MD
Address:
7601 W. Jefferson Blvd
Fort Wayne, IN 46804
Coordinator contact:
Kelly Francher, CCRC
Phone:
260-436-8686
Email:
research@fwortho.com
Louisiana:
Name of center:
Louisiana Orthopedic
Primary investigator:
Jorge E. Isaza, MD
Location:
16777 Medical Center Drive
Baton Rouge, LA 70816
Contact name:
Maria Reyes
Phone number:
225-751-6666
Fax number:
225-751-6680
Website:
www.louisianaortho.com
Maryland:
Name of center:
Greater Baltimore Medical Center
Primary investigator:
Reginald Davis, MD
Location:
6569 N. Charles Street, Suite 403
Baltimore, MD 21204
Contact name:
Jackie Murphy, RN
Phone number:
410-828-4621
Fax number:
410-321-9773
Name of center:
Scoliosis and Spine Center
Primary investigator:
Paul C. McAfee, MD
Location:
1505 Osler Drive, Suite 104
Towson, MD 21204
Contact name:
Erin Shicosky, RN
Phone number:
410-337-8888
Fax number:
410-822-4833
Michigan
Name of center:
Michigan Brain & Spine Institute
Primary investigator:
Douglas F. Geiger, MD
Location:
5315 Elliot Dr., Suite 102
Ypsilanti, Michigan 48197
Contact name:
Dori Danbury, PA
Phone number:
734-434-4110
Fax number:
734-434-1966
Email:
dgeiger@MiBSi.com
Website:
www.MiBSi.com
Minnesota:
Primary investigator:
John Sherman, MD
Location:
6600 France Ave. S., Suite 605
Edina, MN 55435
Contact name:
Barb deBorhegyi, RN
Phone number:
952-920-4333 x325
New York:
Name of center:
Upstate Medical University
Primary investigator:
Hansen A. Yuan, MD
Location:
550 Harrison Center, Suite 130
Syracuse, NY 13202
Contact name:
Susan Hemingway
Phone number:
315-464-8608
North Carolina:
Name of center:
Triangle Orthopaedic Associates, P.A.
Primary investigator:
Tom Dimmig, MD
Location:
120 William Penn Plaza
Durham, NC 27704
Contact name:
Carol Barmann, MS, CCRP
Phone number:
919-281-1784
Fax number:
919-220-6971
Pennsylvania:
Center:
Orthopaedic Speciality Center
Primary investigator:
Guy Lee, MD
Address:
2400 Maryland Road, Suite 20
Willow Grove, PA 19090
Coordinator contact:
Antoinette Bailey
Phone:
215-830-8700 x3121
Fax:
215-830-3058
Email:
abailey@oscdoctor.com
Website:
www.oscdoctors.com
South Carolina:
Name of center:
Spine
Primary investigator:
Jeffrey K. Wingate, MD
Location:
887 Johnnie Dodds Blvd., Suite 100
Mt. Pleasant, SC 29464
Contact name:
Celeste Cornish, RN
Phone number:
843-388-0606
Fax number:
843-388-0607
Texas:
Center:
Texas Back Institute
Primary investigator:
Michael Hisey, MD
Address:
6300 West Parker Road
Plano, TX 75093
Coordinator contact:
Tessa Bolt, CMA, CCRC
Phone:
972-608-5193
Email:
tbolt@Texasback.com
website:
www.texasback.com
Center:
Central Texas Spine Institute
Primary investigator:
Randall F. Dryer, MD
Address:
6818 Austin Center Blvd., Suite 200
Austin, Texas 78731
Coordinator contact:
Amy Sasser
Phone:
512-217-2719
Fax:
512-374-1077
Email:
asasser@pqrinc.com
Website:
www.spine-ctsi.com
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The information provided by Spine-Health in this Clinical Trials listing section is designed to help patients find clinical trials that are ongoing in the field of spine medicine, and to provide information to help patients contact the centers conducting the research. Spine-Health is not involved in conducting any of these trials and is not promoting the trials or research.
This is a listing of industry-sponsored clinical trials that are actively recruiting patients. These clinical trial listings are not edited or peer-reviewed by Spine-health.com.
INFORMATION SOURCE:http://www.spine-health.com/research/trials/dynesys/dynesys01.html