2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C

Description

A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD).

Conditions

Symptomatic Cervical Disc Disease

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Study Overview

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Study Details

Study overview

A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD).

A Multi-Center, Prospective, Randomized Controlled Trial Comparing the Safety and Effectiveness of Prodisc® C SK and Prodisc® C Vivo to Mobi-C® Cervical Disc in the Treatment of Two-Level Symptomatic Cervical Disc Disease (SCDD)

2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C

Condition
Symptomatic Cervical Disc Disease
Intervention / Treatment

-

Contacts and Locations

Flagstaff

Flagstaff Bone and Joint, Flagstaff, Arizona, United States, 86001

Beverly Hills

Todd Lanman, MD, Inc., Beverly Hills, California, United States, 90210

Los Angeles

Doctors Outpatient Center for Surgery, Los Angeles, California, United States, 90048

Palo Alto

Sutter Health - Palo Alto Medical Foundation, Palo Alto, California, United States, 94301

Sacramento

Sutter Health, Sacramento, California, United States, 95816

Lone Tree

Sky Ridge Medical Center Campus, Lone Tree, Colorado, United States, 80124

Thornton

Center for Spine and Orthopedics, Scientific Education and Research Foundation, Thornton, Colorado, United States, 80229

Washington

Georgetown University Hospital, Washington, District of Columbia, United States, 20007

Jacksonville

St. Vincent's Neurosurgery, Jacksonville, Florida, United States, 32204

Sarasota

Kennedy-White Orthopaedic Center, Sarasota, Florida, United States, 34232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age ≥18 and ≤69 years.
  • 2. Diagnosis of radiculopathy or myelopathy with radiculopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following:
  • 3. Symptomatic cervical disc disease (SCDD) at two contiguous levels from C3 to C7.
  • 4. Radiographically determined pathology at the level to be treated correlating to primary symptoms.
  • 5. Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics)
  • 1. Have more than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions.
  • 2. Have previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.
  • 3. Have had a prior cervical TDR or fusion procedure at any level.
  • 4. Have osteoporosis or is at increased risk of osteoporosis
  • 5. Have active malignancy that included a history of any invasive malignancy (except non-melanoma skin cancer), unless the subject had been treated with curative intent and there had been no clinical signs or symptoms of the malignancy for at least 5 years.
  • 6. Have known allergies to cobalt, chromium, molybdenum, titanium, nickel or polyethylene.
  • 7. Have rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal system.
  • 8. Have concomitant conditions requiring daily, high-dose oral and/or inhaled steroids.
  • 9. Have a Body Mass Index (BMI) \> 40 kg/m2.
  • 10. Taking medications known to potentially interfere with bone/soft tissue healing (e.g., high-dose oral and/or inhaled steroids, immunosuppressant medication, chemotherapeutic agents).
  • 11. Have a current history of heavy smoking (more than one pack of cigarettes per day).

Ages Eligible for Study

18 Years to 69 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Centinel Spine,

James Kuras, STUDY_DIRECTOR, Centinel Spine

Study Record Dates

2028-02