Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 69 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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. Neck and/or arm pain (at least 30 mm on the 100 mm visual analogue scale [VAS] scale).
  4. Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale.
  5. Abnormal sensation including hyperesthesia or hypoesthesia; and/or
  6. Abnormal reflexes.
  7. Symptomatic cervical disc disease (SCDD) at two contiguous levels from C3 to C7.
  8. Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following:
  9. Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc.
  10. Degenerative spondylosis on CT or MRI.
  11. Disc herniation on CT or MRI.
  12. NDI Score of ≥ 30%
  13. Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:
  14. Approximately six weeks from radiculopathy or myelopathy with radiculopathy symptom onset; or
  15. Have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative, conservative treatment; or
  16. 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:
  14. Translation ≥ 3.5 mm, and/or
  15. Greater than 11° angular difference to that of either adjacent level.
  16. Have known allergies to cobalt, chromium, molybdenum, titanium, nickel or polyethylene.
  17. Have segmental angulation of greater than 11° at treatment or adjacent levels.
  18. Have rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal system.
  19. Have congenital bony and/or spinal cord abnormalities that affect spinal stability.
  20. Have concomitant conditions requiring daily, high-dose oral and/or inhaled steroids.
  21. Have a Body Mass Index (BMI) > 40 kg/m2.
  22. Taking medications known to potentially interfere with bone/soft tissue healing (e.g., high-dose oral and/or inhaled steroids, immunosuppressant medication, chemotherapeutic agents).
  23. Have a current history of heavy smoking (more than one pack of cigarettes per day).
  24. Have had an epidural steroid injection within 14 days prior to surgery.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
multi-center, prospective, randomized, controlled comparison
Primary Purpose
Treatment
Masking
Single (Participant)
Masking Description
Patient is blinded to their treatment randomization until after surgery.

Arm Groups

ArmDescriptionAssigned Intervention
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).

Recruiting Locations

University of Maryland Medical Center
Baltimore, Maryland 21201
Contact:
Jacob Bruckner, MD
410-328-8808
jbruckner@som.umaryland.edu

More Details

Status
Recruiting
Sponsor
Centinel Spine

Study Contact

Angela Waltman
484-887-8867
a.waltman@centinelspine.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.