ACTIVE_NOT_RECRUITING

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

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Conditions

Symptomatic Cervical Disc DiseaseSCDDneck painradiculopathymyelopathycervical spine painneck surgerycervical surgeryarm numbnesshand numbnessarm tinglinghand tinglingarm weakness

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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)

Quick Facts

Study Start:2019-08-05
Study Completion:2028-05-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04012996

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.

Ages Eligible for Study:18 Years to 69 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥18 and ≤69 years.
  2. 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. 3. Symptomatic cervical disc disease (SCDD) at two contiguous levels from C3 to C7.
  4. 4. Radiographically determined pathology at the level to be treated correlating to primary symptoms.
  5. 5. Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics)
  1. 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. 2. Have previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.
  3. 3. Have had a prior cervical TDR or fusion procedure at any level.
  4. 4. Have osteoporosis or is at increased risk of osteoporosis
  5. 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. 6. Have known allergies to cobalt, chromium, molybdenum, titanium, nickel or polyethylene.
  7. 7. Have rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal system.
  8. 8. Have concomitant conditions requiring daily, high-dose oral and/or inhaled steroids.
  9. 9. Have a Body Mass Index (BMI) \> 40 kg/m2.
  10. 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. 11. Have a current history of heavy smoking (more than one pack of cigarettes per day).

Contacts and Locations

Principal Investigator

James Kuras
STUDY_DIRECTOR
Centinel Spine

Study Locations (Sites)

Flagstaff Bone and Joint
Flagstaff, Arizona, 86001
United States
Todd Lanman, MD, Inc.
Beverly Hills, California, 90210
United States
Doctors Outpatient Center for Surgery
Los Angeles, California, 90048
United States
Sutter Health - Palo Alto Medical Foundation
Palo Alto, California, 94301
United States
Sutter Health
Sacramento, California, 95816
United States
HCA Healthcare
Lone Tree, Colorado, 80124
United States
Sky Ridge Medical Center Campus
Lone Tree, Colorado, 80124
United States
Center for Spine and Orthopedics, Scientific Education and Research Foundation
Thornton, Colorado, 80229
United States
Georgetown University Hospital
Washington, District of Columbia, 20007
United States
St. Vincent's Neurosurgery
Jacksonville, Florida, 32204
United States
Kennedy-White Orthopaedic Center
Sarasota, Florida, 34232
United States
University of South Florida
Tampa, Florida, 33606
United States
Florida Orthopaedic Institute
Temple Terrace, Florida, 33637
United States
Indiana Spine Group
Carmel, Indiana, 46032
United States
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42003
United States
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201
United States
William Beaumont Hospital
Royal Oak, Michigan, 48073
United States
University Spine Center
Wayne, New Jersey, 07470
United States
NYU Langone Orthopedic Hospital
New York, New York, 10003
United States
Hospital for Special Surgery
New York, New York, 10021
United States
Northwell Health, Lenox Hill Hospital
New York, New York, 10075
United States
Axis Neurosurgery and Spine
Williamsville, New York, 14221
United States
M3-Emerging Medical Resarch
Durham, North Carolina, 27704
United States
SVCMC Solon Medical - Northern Ohio Surgery Center
Beachwood, Ohio, 44122
United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
DFW Center for Spinal Disorders
Fort Worth, Texas, 76132
United States
Texas Back Institute
Plano, Texas, 75093
United States
Texas Spine Care Center
San Antonio, Texas, 78231
United States
The Disc Replacement Center
Salt Lake City, Utah, 84088
United States

Collaborators and Investigators

Sponsor: Centinel Spine

  • James Kuras, STUDY_DIRECTOR, Centinel Spine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-05
Study Completion Date2028-05-13

Study Record Updates

Study Start Date2019-08-05
Study Completion Date2028-05-13

Terms related to this study

Keywords Provided by Researchers

  • symptomatic cervical disc disease
  • SCDD
  • neck pain
  • radiculopathy
  • myelopathy
  • cervical spine pain
  • neck surgery
  • cervical surgery
  • arm numbness
  • hand numbness
  • arm tingling
  • hand tingling
  • arm weakness

Additional Relevant MeSH Terms

  • Symptomatic Cervical Disc Disease