A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Single Level Cervical Disc Disease

NCT ID: NCT04520776

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-02
• Study Completion Date: 2026-02-28

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). Subjects will be randomized in a 2:1 ratio to the one-level BAGUERA®C Cervical Disc Prosthesis (investigational group) or to the one-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.

Conditions

Cervical Disc Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BAGUERA®C

surgical placement of the BAGUERA®C Cervical Disc Prosthesis

Group Type: EXPERIMENTAL

BAGUERA®C Cervical Disc Prosthesis

Intervention Type: DEVICE

surgery

Mobi-C®

surgical placement of the Mobi-C® Cervical Disc

Group Type: ACTIVE_COMPARATOR

Mobi-C® Cervical Disc

Intervention Type: DEVICE

surgery

Interventions

BAGUERA®C Cervical Disc Prosthesis

surgery

Intervention Type: DEVICE

Mobi-C® Cervical Disc

surgery

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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 40 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 one level 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 or arm pain ≥ 40 (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

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 fusion or artificial disc procedure at any cervical level.

7. Axial neck pain alone 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 lateral 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. Severe diabetes mellitus requiring daily insulin management.

13. 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.

14. Symptomatic SCDD or significant cervical spondylosis at more than one level.

15. Spondylolysis.

16. 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.

17. Known allergy to Titanium, Vanadium, Aluminum, cobalt, chromium, molybdenum or polyethylene.

18. Segmental angulation of greater than 11° at treatment or adjacent levels.

19. Pregnant at time of enrollment, or with plans to become pregnant within the next three years.

20. Have rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal system.

21. Congenital bony and/or spinal cord abnormalities that affect spinal stability.

22. Have diseases or conditions that would preclude accurate clinical evaluation (e.g. neuromuscular disorders, confirmed fibromyalgia, etc.).

23. 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.

24. Have current or recent history of substance abuse (alcoholism and/or narcotic addiction) requiring intervention.

25. Severe Obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines Body Mass Index (BMI) > 40).

26. Use of any investigational drug or other investigational medical device within the last 30 days prior to surgery.

27. Taking medications known to 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 #23.

28. Have pending personal litigation relating to a spinal injury (does not include worker's compensation).

29. Current history of heavy nicotine use (e.g. more than one pack of cigarettes per day).

30. Circumstances that may interfere with completion of follow-up examinations, including location of residence.

31. Belong to a vulnerable population (e.g., prisoner, wards of the court or developmentally disabled).

32. Currently experiencing an acute or chronic episode of confirmed specific mental illness (psychosis, major affective disorder, or schizophrenia), or manifesting physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin.

33. Have an uncontrolled seizure disorder.

34. Received cervical spine epidural steroids within 14 days prior to surgery.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spineart USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MORE Foundation

Phoenix, Arizona, United States

Desert Institute for Spine Care

Scottsdale, Arizona, United States

BEEL Medical

Laguna Hills, California, United States

Orange County Neurosurgical Associates

Mission Viejo, California, United States

The Huffman Clinic at Napa Valley Orthopaedic Group

Napa, California, United States

UCI Health

Orange, California, United States

Eisenhower Medical Center

Rancho Mirage, California, United States

The Spine Institute, Center for Spine Restoration

Santa Monica, California, United States

The Institute of Neuro Innovation

West Hills, California, United States

Vail-Summit Orthopaedics and Neurosurgery

Vail, Colorado, United States

Hartford Healthcare CT Orthopaedics

Hamden, Connecticut, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Legacy Brain & Spine

Atlanta, Georgia, United States

Midwest Orthopedics at RUSH

Chicago, Illinois, United States

NorthShore University

Evanston, Illinois, United States

Indiana Spine Group

Carmel, Indiana, United States

Ortho NorthEast

Fort Wayne, Indiana, United States

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, United States

Spine Institute of Louisiana

Shreveport, Louisiana, United States

Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, United States

The Ohio Sate University - Dept of Orthopedics

Columbus, Ohio, United States

Oregon Spine Care

Tualatin, Oregon, United States

Neurosurgical Associates of Lancaster

Lancaster, Pennsylvania, United States

Center for Sports Medicine & Orthopedics

Chattanooga, Tennessee, United States

St. David's Healthcare

Austin, Texas, United States

The Disc Replacement Center

Salt Lake City, Utah, United States

Swedish Neuroscience, Swedish Spine Institute

Seattle, Washington, United States

Countries

United States

Other Identifiers

CT-20-001-001

Identifier Type: -

Identifier Source: org_study_id