The Dynesys® Spinal System Clinical Trial

(Sponsored clinical trial listing)

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.

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

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

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