Status:
ACTIVE_NOT_RECRUITING
2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
Lead Sponsor:
Centinel Spine
Conditions:
Symptomatic Cervical Disc Disease
Eligibility:
All Genders
18-69 years
Phase:
NA
Brief Summary
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 symptom...
Detailed Description
The clinical trial is to demonstrate that prodisc C SK and prodisc C Vivo are at least as safe and effective as a similar, currently marketed cervical disc prosthesis to treat symptomatic cervical dis...
Eligibility Criteria
Inclusion
- 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 through C7, 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 to primary symptoms.
- Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics)
Exclusion
- 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.
- Have previous trauma to the C3 to C7 levels resulting in significant bony or disco-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 (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.
- Have known allergies to cobalt, chromium, molybdenum, titanium, nickel or polyethylene.
- Have rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal 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, chemotherapeutic agents).
- Have a current history of heavy smoking (more than one pack of cigarettes per day).
Key Trial Info
Start Date :
August 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 13 2028
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT04012996
Start Date
August 5 2019
End Date
May 13 2028
Last Update
July 30 2025
Active Locations (30)
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1
Flagstaff Bone and Joint
Flagstaff, Arizona, United States, 86001
2
Todd Lanman, MD, Inc.
Beverly Hills, California, United States, 90210
3
Doctors Outpatient Center for Surgery
Los Angeles, California, United States, 90048
4
Sutter Health - Palo Alto Medical Foundation
Palo Alto, California, United States, 94301