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

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)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Symptomatic Cervical Disc Disease
• Intervention / Treatment: Device: prodisc C SK and/or Vivo; Device: Mobi-C Cervical Disc

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.

• Study Type: Interventional
• Enrollment (Estimated): 390
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational; Two-level prodisc C SK and/or prodisc C Vivo	Device: prodisc C SK and/or Vivo; Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).
Active Comparator: Control; Two-level Mobi-C device	Device: Mobi-C Cervical Disc; Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Includes assessments such as NDI and neurological improvement.	24 months

Collaborators and Investigators

• Sponsor: Centinel Spine
• Investigators: Study Director: James Kuras, Centinel Spine

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2019
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): May 13, 2028

Study Registration Dates

• First Submitted: July 5, 2019
• First Submitted That Met QC Criteria: July 5, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: neck pain; radiculopathy; myelopathy; arm weakness; symptomatic cervical disc disease; SCDD; cervical spine pain; neck surgery; cervical surgery; arm numbness; hand numbness; arm tingling; hand tingling
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Hernia; Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Meloxicam
• Other Study ID Numbers: VAL-P-0022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes