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

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ClinicalTrials.gov Identifier: NCT04012996
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Centinel Spine

Tracking Information
First Submitted Date  ICMJE July 5, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date April 1, 2021
Actual Study Start Date  ICMJE August 5, 2019
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2019)
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) [ Time Frame: 24 months ]
Includes assessments such as NDI and neurological improvement.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
multi-center, prospective, randomized, controlled comparison
Masking: Single (Participant)
Masking Description:
Patient is blinded to their treatment randomization until after surgery.
Primary Purpose: Treatment
Condition  ICMJE Symptomatic Cervical Disc Disease
Intervention  ICMJE
  • 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).
  • 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).
Study Arms  ICMJE
  • Experimental: Investigational
    Two-level prodisc C SK and/or prodisc C Vivo
    Intervention: Device: prodisc C SK and/or Vivo
  • Active Comparator: Control
    Two-level Mobi-C device
    Intervention: Device: Mobi-C Cervical Disc
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 5, 2019)
390
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2028
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

    1. Neck and/or arm pain (at least 30 mm on the 100 mm visual analogue scale [VAS] scale).
    2. Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale.
    3. Abnormal sensation including hyperesthesia or hypoesthesia; and/or
    4. Abnormal reflexes.
  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 including at least one of the following:

    1. Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc.
    2. Degenerative spondylosis on CT or MRI.
    3. Disc herniation on CT or MRI.
  5. NDI Score of ≥ 30%
  6. Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:

    1. Approximately six weeks from radiculopathy or myelopathy with radiculopathy symptom onset; or
    2. Have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative, conservative treatment; or
    3. Sooner than 6 weeks for worsening symptoms of neurologic compromise.

Exclusion Criteria:

  1. Have an active systemic infection or infection at the operative site.
  2. Have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C.
  3. 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.
  4. Have previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.
  5. Have had any prior spine surgery at the operative level(s).
  6. Have had a prior cervical TDR or fusion procedure at any level.
  7. Have axial neck pain in the absence of other symptoms of radiculopathy or myelopathy with radiculopathy justifying the need for surgical intervention.
  8. Have disc height less than 3 mm as measured from the center of the disc in a neutral position and disc height less than 20% of the anterior-posterior width of the inferior vertebral body.
  9. Have radiographic confirmation of severe facet joint disease or degeneration at any level.
  10. Have osteoporosis or is at increased risk of osteoporosis defined as a DEXA bone density measured T-score of ≤ -1.5. A DEXA performed within 24 months of the surgery date may be used to determine eligibility. For subjects without a DEXA within 24 months of the surgery date a score ≥6 on either the SCORE or MORES requires a DEXA to determine eligibility.
  11. 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.
  12. Have Symptomatic Cervical Disc Disease or significant cervical spondylosis at more than two levels.
  13. Have marked cervical instability on resting (neutral) lateral or flexion-extension radiographs demonstrated by:

    1. Translation ≥ 3.5 mm, and/or
    2. Greater than 11° angular difference to that of either adjacent level.
  14. Have known allergies to cobalt, chromium, molybdenum, titanium, nickel or polyethylene.
  15. Have segmental angulation of greater than 11° at treatment or adjacent levels.
  16. Have rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal system.
  17. Have congenital bony and/or spinal cord abnormalities that affect spinal stability.
  18. Have concomitant conditions requiring daily, high-dose oral and/or inhaled steroids.
  19. Have a Body Mass Index (BMI) > 40 kg/m2.
  20. Taking medications known to potentially interfere with bone/soft tissue healing (e.g., high-dose oral and/or inhaled steroids, immunosuppressant medication, chemotherapeutic agents).
  21. Have a current history of heavy smoking (more than one pack of cigarettes per day).
  22. Have had an epidural steroid injection within 14 days prior to surgery.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Angela Waltman 484-887-8867 a.waltman@centinelspine.com
Contact: Leonard Voronov, MD, PhD 484-887-8838 l.voronov@centinelspine.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012996
Other Study ID Numbers  ICMJE VAL-P-0022
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centinel Spine
Study Sponsor  ICMJE Centinel Spine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Leonard I Voronov, MD, PhD Centinel Spine
PRS Account Centinel Spine
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP