Clinical trial NCT04012996: 2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Symptomatic Cervical Disc Disease
Keywords: 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
Lead sponsor: Centinel Spine
Sponsor class: INDUSTRY
First posted: 2019-07-09
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multi-center, prospective, randomized, controlled comparison
Primary purpose: TREATMENT

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 symptomatic cervical disc disease (SCDD).

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 disc disease (SCDD) in subjects at two contiguous levels from C3 to C7 who are unresponsive to conservative management. Subjects will be randomized in a 2:1 ratio to either the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group). Subjects will be followed for at least 2 years and up to 5 years. Subjects will be required to complete subject questionnaires, have X-rays and undergo neurological assessments during the follow up visits as specified in the protocol.

Eligibility criteria: Inclusion 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)

Exclusion Criteria:

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).

Primary outcomes:
measure: Composite clinical success rate of the two-level prodisc C SK and prodisc C Vivo will be no worse than marketed cervical disc prosthesis (Mobi-C)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Flagstaff Bone and Joint
state: Arizona
city: Beverly Hills
country: United States
facility: Todd Lanman, MD, Inc.
state: California
city: Los Angeles
country: United States
facility: Doctors Outpatient Center for Surgery
state: California
city: Palo Alto
country: United States
facility: Sutter Health - Palo Alto Medical Foundation
state: California
city: Sacramento
country: United States
facility: Sutter Health
state: California
city: Lone Tree
country: United States
facility: Sky Ridge Medical Center Campus
state: Colorado
city: Thornton
country: United States
facility: Center for Spine and Orthopedics, Scientific Education and Research Foundation
state: Colorado
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Jacksonville
country: United States
facility: St. Vincent's Neurosurgery
state: Florida
city: Sarasota
country: United States
facility: Kennedy-White Orthopaedic Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Temple Terrace
country: United States
facility: Florida Orthopaedic Institute
state: Florida
city: Atlanta
country: United States
facility: Legacy Brain and Spine
state: Georgia
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Paducah
country: United States
facility: Orthopaedic Institute of Western Kentucky
state: Kentucky
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Las Vegas
country: United States
facility: Las Vegas Neurosurgical Institute for Spine and Brain Surgery
state: Nevada
city: Wayne
country: United States
facility: University Spine Center
state: New Jersey
city: New York
country: United States
facility: NYU Langone Orthopedic Hospital
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Northwell Health, Lenox Hill Hospital
state: New York
city: Williamsville
country: United States
facility: Axis Neurosurgery and Spine
state: New York
city: Durham
country: United States
facility: M3-Emerging Medical Resarch
state: North Carolina
city: Beachwood
country: United States
facility: Beachwood Medical Center
state: Ohio
city: Solon
country: United States
facility: St. Vincent Charity Medical Group
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Fort Worth
country: United States
facility: DFW Center for Spinal Disorders
state: Texas
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
city: San Antonio
country: United States
facility: Texas Spine Care Center
state: Texas
city: Salt Lake City
country: United States
facility: The Disc Replacement Center
state: Utah
city: Spokane
country: United States
facility: Multicare Neurosurgery and Spine
state: Washington
Study officials:
affiliation: Centinel Spine
name: James Kuras
role: STUDY_DIRECTOR
References: