UnknownNot Applicable

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

United States284 participantsStarted 2021-03-02

Plain-language 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.

Who can participate

Age range22 Years – 69 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Neck Disability Index

Timeframe: 24 month follow-up visit

Maintenance or improvement in neurological status

Timeframe: 24 month follow-up visit

No secondary surgical intervention per protocol definition

Timeframe: 24 month follow-up visit

Procedure or device related serious adverse events

Timeframe: 24 month follow-up visit

Trial details

NCT IDNCT04520776

SponsorSpineart USA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02

View on ClinicalTrials.gov More Cervical Disc Disease trials

Plain-language summary

Who can participate

Age range22 Years – 69 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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.
✕. 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.