Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Clinical Trial Comparing the BAGUERA®C to the Marketed Mobi-C® for the Treatment of Cervical Disc Disease at 2 Contiguous Levels

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: NCT04564885
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
Spineart USA

Brief Summary:
The proposed investigation is a multi-center, prospective, randomized, controlled comparison of the BAGUERA®C to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD) at two contiguous levels. Subjects will be randomized in a 2:1 ratio to the two-level BAGUERA®C Cervical Disc Prosthesis (investigational group) or to the two-level Mobi-C® Cervical Disc (control group). Subjects enrolled in the study will be evaluated pre-operatively, at the time of surgery, discharge, and at 6 weeks, 3, 6, 12, and 24 months and then annually until 7 years post-surgery.

Condition or disease Intervention/treatment Phase
Cervical Disc Disease Device: BAGUERA®C Cervical Disc Prosthesis Device: Mobi-C Cervical Disc Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: participants will not be told their treatment group prior to surgery
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized, Clinical Trial Comparing the Safety and Effectiveness of the BAGUERA®C Cervical Disc Prosthesis to the Mobi-C® Cervical Disc for the Treatment of Patients With Symptomatic Cervical Disc Disease at Two Contiguous Levels
Actual Study Start Date : March 2, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs
Drug Information available for: Meloxicam

Arm Intervention/treatment
Experimental: BAGUERA®C
surgical placement of the BAGUERA®C Cervical Disc Prosthesis at 2 contiguous levels
Device: BAGUERA®C Cervical Disc Prosthesis
surgery

Active Comparator: Mobi-C®
surgical placement of the Mobi-C® Cervical Disc at 2 contiguous levels
Device: Mobi-C Cervical Disc
surgery




Primary Outcome Measures :
  1. Neck Disability Index [ Time Frame: 24 month follow-up visit ]
    at least a 15 percentage point improvement (decrease) from baseline on a 0 - 100% scale

  2. Maintenance or improvement in neurological status [ Time Frame: 24 month follow-up visit ]
    pre and post-op neurological examination to determine maintenance or improvement

  3. No secondary surgical intervention per protocol definition [ Time Frame: 24 month follow-up visit ]
    any revision, removal, re-operation, or supplemental fixation at the index level

  4. Procedure or device related serious adverse events [ Time Frame: 24 month follow-up visit ]
    No serious adverse event(s) confirmed as device or procedure related as adjudicated by the Clinical Events Committee



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.


Layout table for eligibility information
Ages Eligible for Study:   22 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

In order to be eligible to participate in this study, subjects must meet all of the following criteria:

  1. Male or female; skeletally mature; age 22-69 years, inclusive.
  2. Diagnosis of radiculopathy or myeloradiculopathy of the cervical spine, with pain, paresthesia 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% (raw score of ≥15/50).
  6. Preoperative neck pain ≥ 30 (out of 100) on Preoperative Neck and Arm Pain Questionnaire.
  7. Unresponsive to non-operative, conservative treatment (including but not necessarily limited to: rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:

    1. Approximately six weeks from radiculopathy or myeloradiculopathy symptom onset; or
    2. Have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative conservative treatment.
  8. Appropriate for treatment using an anterior surgical approach, including having no prior surgery at the operative level and no prior cervical fusion or cervical artificial disc procedure at any level.
  9. Medically cleared for surgery.
  10. Physically and mentally able and willing to comply with the Protocol, including the ability to read and complete required forms and willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol.
  11. Written informed consent provided by Subject

Exclusion Criteria

Patients are not permitted to enroll in the two-level BAGUERA®C study if they meet any of the following 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. 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. Previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.
  5. Had any prior spine surgery at the operative level.
  6. Had a prior cervical fusion or artificial disc procedure at any cervical level.
  7. Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy.
  8. Disc height less than 3 mm as measured from the center of the disc in a neutral position.
  9. Radiographic confirmation of severe facet joint degeneration or confirmed clinical evidence that facet joint degeneration is a major contributor to the subject's pain.
  10. Have osteoporosis or osteopenia, defined as a DEXA bone density measured T-score of ≤ -1.5 (i.e. -1.6, -1.7, etc.). 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 of ≥ 6 on either the SCORE or MORES requires a DEXA to determine eligibility. Note: The SCORE (Simple Calculated Osteoporosis Risk Estimation) form should be administered if the subject is female. The MORES (Male Osteoporosis Risk Estimation Score) form should be administered if the subject is male.
  11. Have Paget's disease, osteomalacia or any other metabolic bone disease other than osteoporosis, which is addressed above.
  12. Have an active malignancy that includes a history of any invasive malignancy (except non-melanoma skin cancer), unless the subject was treated with curative intent and there had been no clinical signs or symptoms of the malignancy for at least five years.
  13. Symptomatic SCDD or significant cervical spondylosis at more than two levels.
  14. Spondylolysis.
  15. Marked cervical instability on resting 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.
  16. Known allergy to Titanium, Vanadium, Aluminum, cobalt, chromium, molybdenum or polyethylene.
  17. Segmental angulation of greater than 11° at treatment or adjacent levels.
  18. Pregnant at time of enrollment, or with plans to become pregnant within the next three years.
  19. Have rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal system.
  20. Congenital bony and/or spinal cord abnormalities that affect spinal stability.
  21. Have diseases or conditions that would preclude accurate clinical evaluation (e.g. neuromuscular disorders, confirmed fibromyalgia, etc.).
  22. Concomitant conditions requiring daily, high-dose oral and/or inhaled steroids. High dose steroid use is defined as:

    1. Daily, chronic use of oral steroids of 5 mg/day or greater.
    2. Daily, chronic use of inhaled corticosteroids (at least twice per day).
    3. Use of short-term (less than 10 days) oral steroids at a daily dose greater than 40mg within one month of the study procedure.
  23. Have current or recent history of substance abuse (alcoholism and/or narcotic addiction) requiring intervention.
  24. Severe Obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines Body Mass Index (BMI) > 40).
  25. Use of any investigational drug or other investigational medical device within the last 30 days prior to surgery.
  26. Taking medications known to potentially interfere with bone/soft tissue healing (e.g., high-dose oral and/or inhaled steroids, immunosuppressant medication, chemotherapeutic agents). High dose steroid use is defined as part of Exclusion Criterion #22.
  27. Have pending personal litigation relating to spinal injury (does not include worker's compensation).
  28. Current history of heavy nicotine use (e.g. more than one pack of cigarettes per day).
  29. Circumstances that may interfere with completion of follow-up examinations, including location of residence.
  30. Mental illness or belong to a vulnerable population (e.g., prisoner or developmentally disabled), that in the belief of the investigator, that would compromise ability to provide informed consent or compliance with follow-up requirements.
  31. Have an uncontrolled seizure disorder.
  32. Received cervical spine epidural steroids within 14 days prior to surgery

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): NCT04564885


Contacts
Layout table for location contacts
Contact: Seth Kaufman 949-683-5681 enocco@spineart.com

Locations
Layout table for location information
United States, North Carolina
Carolina Neurosurgery and Spine Associates Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Peggy Boltes, RN         
Sponsors and Collaborators
Spineart USA
Layout table for additonal information
Responsible Party: Spineart USA
ClinicalTrials.gov Identifier: NCT04564885    
Other Study ID Numbers: CT-20-002-002
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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 Spineart USA:
radiculopathy
myeloradiculopathy
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Diseases
Intervertebral Disc Displacement
Intervertebral Disc Degeneration
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