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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04012996
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Centinel Spine

Study Description
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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).

Condition or disease Intervention/treatment Phase
Symptomatic Cervical Disc Disease Device: prodisc C SK and/or Vivo Device: Mobi-C Cervical Disc Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
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
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)
Actual Study Start Date : August 5, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : February 2028

Resource links provided by the National Library of Medicine

Drug Information available for: Meloxicam

Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

    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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04012996


Contacts
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Contact: Angela Waltman 484-887-8867 a.waltman@centinelspine.com
Contact: Leonard Voronov, MD, PhD 484-887-8838 l.voronov@centinelspine.com

Locations
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Sponsors and Collaborators
Centinel Spine
More Information
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Responsible Party: Centinel Spine
ClinicalTrials.gov Identifier: NCT04012996    
Other Study ID Numbers: VAL-P-0022
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Centinel Spine:
symptomatic cervical disc disease
SCDD
neck pain
 radiculopathy
myelopathy
cervical spine pain
Additional relevant MeSH terms:
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Intervertebral Disc Displacement
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action