Suspended

SMARTA 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)

What is being tested

prodisc C SK and/or Vivo

+ Mobi-C Cervical Disc

Device

Who is being recruted

Central Nervous System Diseases+9

+ Nervous System Diseases

+ Neurologic Manifestations

From 18 to 69 Years

+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: August 2019

See protocol details

Summary

Principal SponsorCentinel Spine

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 5, 2019

Actual date on which the first participant was enrolled.

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.

Official TitleA 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)

NCT04012996

Principal SponsorCentinel Spine

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

390 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 69 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Central Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsNeuromuscular DiseasesPainParesisPeripheral Nervous System DiseasesRadiculopathySigns and SymptomsSpinal Cord DiseasesPathological Conditions, Signs and SymptomsNeck Pain

Criteria

5 inclusion criteria required to participate

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.

Show More Criteria

11 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Two-level prodisc C SK and/or prodisc C Vivo

Group II

Active Comparator

Two-level Mobi-C device

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 30 locations

Suspended

Flagstaff Bone and Joint

Flagstaff, United StatesOpen Flagstaff Bone and Joint in Google Maps

Suspended

Todd Lanman, MD, Inc.

Beverly Hills, United States

Suspended

Doctors Outpatient Center for Surgery

Los Angeles, United States

Suspended

Sutter Health - Palo Alto Medical Foundation

Palo Alto, United States

Suspended30 Study Centers