Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages 18-69 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥18 and ≤69 years.
- Diagnosis of radiculopathy or myelopathy with radiculopathy of the cervical spine,with pain, paresthesias or paralysis in a specific nerve root distribution C3 throughC7, including at least one of the following:
- Symptomatic cervical disc disease (SCDD) at two contiguous levels from C3 to C7.
- Radiographically determined pathology at the level to be treated correlating toprimary symptoms.
- Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy,physical therapy, chiropractic care and/or analgesics)
Exclusion
Exclusion Criteria:
- Have more than one immobile vertebral level between C1 to C7 from any cause includingbut not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions.
- Have previous trauma to the C3 to C7 levels resulting in significant bony ordisco-ligamentous cervical spine injury.
- Have had a prior cervical TDR or fusion procedure at any level.
- Have osteoporosis or is at increased risk of osteoporosis
- Have active malignancy that included a history of any invasive malignancy (exceptnon-melanoma skin cancer), unless the subject had been treated with curative intentand there had been no clinical signs or symptoms of the malignancy for at least 5years.
- Have known allergies to cobalt, chromium, molybdenum, titanium, nickel orpolyethylene.
- Have rheumatoid arthritis, lupus, or other autoimmune disease that affect themusculoskeletal system.
- Have concomitant conditions requiring daily, high-dose oral and/or inhaled steroids.
- Have a Body Mass Index (BMI) > 40 kg/m2.
- Taking medications known to potentially interfere with bone/soft tissue healing (e.g.,high-dose oral and/or inhaled steroids, immunosuppressant medication, chemotherapeuticagents).
- Have a current history of heavy smoking (more than one pack of cigarettes per day).
Study Design
Study Description
Connect with a study center
Flagstaff Bone and Joint
Flagstaff, Arizona 86001
United StatesActive - Recruiting
Todd Lanman, MD, Inc.
Beverly Hills, California 90210
United StatesActive - Recruiting
Doctors Outpatient Center for Surgery
Los Angeles, California 90048
United StatesActive - Recruiting
Sutter Health - Palo Alto Medical Foundation
Palo Alto, California 94301
United StatesActive - Recruiting
Sutter Health
Sacramento, California 95816
United StatesActive - Recruiting
Sky Ridge Medical Center Campus
Lone Tree, Colorado 80124
United StatesActive - Recruiting
Center for Spine and Orthopedics, Scientific Education and Research Foundation
Thornton, Colorado 80229
United StatesActive - Recruiting
Georgetown University Hospital
Washington, District of Columbia 20007
United StatesActive - Recruiting
St. Vincent's Neurosurgery
Jacksonville, Florida 32204
United StatesActive - Recruiting
Kennedy-White Orthopaedic Center
Sarasota, Florida 34232
United StatesActive - Recruiting
University of South Florida
Tampa, Florida 33606
United StatesActive - Recruiting
Florida Orthopaedic Institute
Temple Terrace, Florida 33637
United StatesActive - Recruiting
Legacy Brain and Spine
Atlanta, Georgia 30339
United StatesActive - Recruiting
Indiana Spine Group
Carmel, Indiana 46032
United StatesActive - Recruiting
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky 42003
United StatesActive - Recruiting
Spine Institute of Louisiana
Shreveport, Louisiana 71101
United StatesActive - Recruiting
University of Maryland Medical Center
Baltimore, Maryland 21201
United StatesActive - Recruiting
Georgetown University Hospital
Chevy Chase, Maryland 20815
United StatesSite Not Available
William Beaumont Hospital
Royal Oak, Michigan 48073
United StatesActive - Recruiting
Las Vegas Neurosurgical Institute for Spine and Brain Surgery
Las Vegas, Nevada 89117
United StatesSite Not Available
University Spine Center
Wayne, New Jersey 07470
United StatesSite Not Available
Hospital for Special Surgery
New York, New York 10021
United StatesActive - Recruiting
NYU Langone Orthopedic Hospital
New York, New York 10003
United StatesActive - Recruiting
Northwell Health, Lenox Hill Hospital
New York, New York 10075
United StatesActive - Recruiting
Axis Neurosurgery and Spine
Williamsville, New York 14221
United StatesActive - Recruiting
OrthoCarolina Research Institute
Charlotte, North Carolina 28207
United StatesSite Not Available
M3-Emerging Medical Resarch
Durham, North Carolina 27704
United StatesActive - Recruiting
Beachwood Medical Center
Beachwood, Ohio 44122
United StatesActive - Recruiting
St. Vincent Charity Medical Group
Solon, Ohio 44139
United StatesSite Not Available
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesActive - Recruiting
DFW Center for Spinal Disorders
Fort Worth, Texas 76132
United StatesActive - Recruiting
Texas Back Institute
Plano, Texas 75093
United StatesActive - Recruiting
Texas Spine Care Center
San Antonio, Texas 78231
United StatesActive - Recruiting
The Disc Replacement Center
Salt Lake City, Utah 84088
United StatesActive - Recruiting
Multicare Neurosurgery and Spine
Spokane, Washington 99218
United StatesActive - Recruiting
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