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

Symptomatic Cervical Disc Disease Clinical Trial

— SMART  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04012996
• Other study ID #: VAL-P-0022
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2019
• Est. completion date: February 2028

Study information

• Verified date: October 2022
• Source: Centinel Spine
• Contact: James Kuras
• Phone: 484.887.8873
• Email: j.kuras[@]centinelspine.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: February 2028
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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).

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Symptomatic Cervical Disc Disease

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Legacy Brain and Spine	Atlanta	Georgia
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Beachwood Medical Center	Beachwood	Ohio
United States	Todd Lanman, MD, Inc.	Beverly Hills	California
United States	Indiana Spine Group	Carmel	Indiana
United States	M3-Emerging Medical Resarch	Durham	North Carolina
United States	Flagstaff Bone and Joint	Flagstaff	Arizona
United States	DFW Center for Spinal Disorders	Fort Worth	Texas
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	St. Vincent's Neurosurgery	Jacksonville	Florida
United States	Las Vegas Neurosurgical Institute for Spine and Brain Surgery	Las Vegas	Nevada
United States	Sky Ridge Medical Center Campus	Lone Tree	Colorado
United States	Doctors Outpatient Center for Surgery	Los Angeles	California
United States	Hospital for Special Surgery	New York	New York
United States	Northwell Health, Lenox Hill Hospital	New York	New York
United States	NYU Langone Orthopedic Hospital	New York	New York
United States	Orthopaedic Institute of Western Kentucky	Paducah	Kentucky
United States	Sutter Health - Palo Alto Medical Foundation	Palo Alto	California
United States	Texas Back Institute	Plano	Texas
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Sutter Health	Sacramento	California
United States	The Disc Replacement Center	Salt Lake City	Utah
United States	Texas Spine Care Center	San Antonio	Texas
United States	Kennedy-White Orthopaedic Center	Sarasota	Florida
United States	Spine Institute of Louisiana	Shreveport	Louisiana
United States	St. Vincent Charity Medical Group	Solon	Ohio
United States	Multicare Neurosurgery and Spine	Spokane	Washington
United States	University of South Florida	Tampa	Florida
United States	Florida Orthopaedic Institute	Temple Terrace	Florida
United States	Center for Spine and Orthopedics, Scientific Education and Research Foundation	Thornton	Colorado
United States	Georgetown University Hospital	Washington	District of Columbia
United States	University Spine Center	Wayne	New Jersey
United States	Axis Neurosurgery and Spine	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
Centinel Spine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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