A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Cervical Di… (NCT04564885) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Cervical Disc Disease at 2 Contiguous Levels
United States300 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) 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.
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.
Inclusion 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:
Exclusion criteria
✕. Have an active systemic infection or infection at the operative site.
What they're measuring
1
Neck Disability Index
Timeframe: 24 month follow-up visit
2
Maintenance or improvement in neurological status
Timeframe: 24 month follow-up visit
3
No secondary surgical intervention per protocol definition
Timeframe: 24 month follow-up visit
4
Procedure or device related serious adverse events
✕. 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.