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

NCT04564885 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CT-20-002-001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 26

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.

Conditions

Cervical Disc Disease

Keywords

radiculopathy; myeloradiculopathy

Outcome Measures

Primary Outcomes (4)

• Neck Disability Index

  at least a 15 percentage point improvement (decrease) from baseline on a 0 - 100% scale

  24 month follow-up visit

• Maintenance or improvement in neurological status

  pre and post-op neurological examination to determine maintenance or improvement

  24 month follow-up visit

• No secondary surgical intervention per protocol definition

  any revision, removal, re-operation, or supplemental fixation at the index level

  24 month follow-up visit

• Procedure or device related serious adverse events

  No serious adverse event(s) confirmed as device or procedure related as adjudicated by the Clinical Events Committee

  24 month follow-up visit

Study Arms (2)

BAGUERA®C

EXPERIMENTAL

surgical placement of the BAGUERA®C Cervical Disc Prosthesis at 2 contiguous levels

Device: BAGUERA®C Cervical Disc Prosthesis

Mobi-C®

ACTIVE COMPARATOR

surgical placement of the Mobi-C® Cervical Disc at 2 contiguous levels

Device: Mobi-C Cervical Disc

Interventions

BAGUERA®C Cervical Disc Prosthesis DEVICE

surgery

BAGUERA®C

Mobi-C Cervical Disc DEVICE

surgery

Mobi-C®

Eligibility Criteria

• Age: 22 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, subjects must meet all of the following criteria:
• Male or female; skeletally mature; age 22-69 years, inclusive.
• 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:
• Neck and/or arm pain (at least 40 mm on the 100 mm visual analogue scale \[VAS\] scale).
• Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale.
• Abnormal sensation including hyperesthesia or hypoesthesia; and/or
• Abnormal reflexes.
• Symptomatic cervical disc disease (SCDD) at two contiguous levels from C3 to C7.
• Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following:
• Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc.
• Degenerative spondylosis on CT or MRI.
• Disc herniation on CT or MRI.
• NDI Score of ≥ 30% (raw score of ≥15/50).
• Preoperative neck or arm pain ≥ 40 (out of 100) on Preoperative Neck and Arm Pain Questionnaire.
• Unresponsive to non-operative, conservative treatment (including but not necessarily limited to: rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:

You may not qualify if:

• Have an active systemic infection or infection at the operative site.
• Have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C.
• More than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions.
• Previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.
• Had any prior spine surgery at the operative level(s).
• Had a prior fusion or artificial disc procedure at any cervical level.
• Axial neck pain alone in the absence of other symptoms of radiculopathy or myeloradiculopathy.
• Disc height less than 3 mm as measured from the center of the disc in a neutral lateral position.
• Radiographic confirmation of severe facet joint degeneration or confirmed clinical evidence that facet joint degeneration is a major contributor to the subject's pain.
• 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.
• Have Paget's disease, osteomalacia or any other metabolic bone disease other than osteoporosis, which is addressed above.
• Severe diabetes mellitus requiring daily insulin management.
• 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.
• Symptomatic SCDD or significant cervical spondylosis at more than two levels.
• Spondylolysis.

Sponsors & Collaborators

• Spineart USA: lead

Study Sites (26)

MORE Foundation

Phoenix, Arizona, 85023, United States

Location

Desert Institute for Spine Care

Scottsdale, Arizona, 85258, United States

Location

BEEL Medical

Laguna Hills, California, 92653, United States

Location

Orange County Neurosurgical Associates

Mission Viejo, California, 92691, United States

Location

UCI Health

Orange, California, 92868, United States

Location

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

Location

The Spine Institute, Center for Spine Restoration

Santa Monica, California, 90403, United States

Location

Institute for Neuro Innovation

West Hills, California, 91307, United States

Location

Vail-Summit Orthopaedics and Neurosurgery

Vail, Colorado, 81657, United States

Location

Hartford Health CT Orthopaedics

Hamden, Connecticut, 06518, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20057, United States

Location

Legacy Brain & Spine

Atlanta, Georgia, 30339, United States

Location

Midwest Orthopedics at Rush

Chicago, Illinois, 60612, United States

Location

NorthShore

Evanston, Illinois, 60201, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Ortho NorthEast

Fort Wayne, Indiana, 46825, United States

Location

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42001, United States

Location

Spine Institute of Louisiana Foundation

Shreveport, Louisiana, 71101, United States

Location

Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, 28204, United States

Location

The Ohio State University - Dept of Orthadedics

Columbus, Ohio, 43210, United States

Location

Oregon Spine Care

Tualatin, Oregon, 97062, United States

Location

Neurosurgical Associates of Lancaster

Lancaster, Pennsylvania, 17601, United States

Location

Center for Sports Medicine & Orthopedics

Chattanooga, Tennessee, 37404, United States

Location

St. David's Healthcare

Austin, Texas, 78705, United States

Location

The Disc Replacement Center

Salt Lake City, Utah, 84088, United States

Location

Swedish Neuroscience, Swedish Spine Institute

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants will not be told their treatment group prior to surgery
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 25, 2020
• Study Start: March 2, 2021
• Primary Completion: April 1, 2025
• Study Completion (Estimated): April 1, 2030
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (26)