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Tests treatment safety and results for Neck Pain
Official title CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study
ClinicalTrials.gov ID: NCT04883411
What this study is testing
- What it's testing
- The study is a prospective, first-in-human, multi-center, non-randomized, single-arm study to assess the safety and efficacy of the CEM-Cage used with the CEM-Plate in patients who are appropriate candidates for a 2-level anterior cervical discectomy and fusion (ACDF). Fifty patients will be enrolled in the study and, after undergoing a 2-level ACDF, will be evaluated at 4 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 79
You may be able to join if
- Males and females aged 22-79 years.
- Documented diagnosis of cervical spine radiculopathy or myelopathy.
- Symptomatic cervical degenerative disc disease at 2 contiguous levels between C2 through T1.
- Baseline NDI score ≥30 and/or baseline mJOA score ≤16.
- Pathology at the level to be treated correlating to the primary symptoms confirmed by imaging (computed tomography (CT), CT myelography, magnetic...
You likely can't join if
- Any prior cervical surgeries at the symptomatic levels; prior surgery or cervical fusion procedure at any level.
- Fewer than 2 or more than 2 vertebral levels requiring treatment.
- Anatomy that is non-conducive to receiving investigational device.
- More than one immobile vertebral level between C-1 to C-7 from any cause, including but not limited to congenital abnormalities and osteoarthritic...
- Known diagnosis of osteoporosis, current pharmacological treatment for osteoporosis or bone density which in the medical opinion of the surgeon...
- Paget disease, osteomalacia, or any other metabolic bone disease other than osteoporosis.
See the full eligibility criteria
- Males and females aged 22-79 years.
- Documented diagnosis of cervical spine radiculopathy or myelopathy.
- Symptomatic cervical degenerative disc disease at 2 contiguous levels between C2 through T1.
- Baseline NDI score ≥30 and/or baseline mJOA score ≤16.
- Pathology at the level to be treated correlating to the primary symptoms confirmed by imaging (computed tomography (CT), CT myelography, magnetic resonance imaging (MRI), or plain radiography).
- Unresponsive to non-operative, conservative treatment for at least 6 weeks from symptom onset or presence of progressive cervical myelopathy or signs of nerve root/spinal cord compression despite continued non-operative...
- Ability to speak, read, and understand the IRB approved Informed Consent document.
- Willingness to give informed consent for participation in the study.
- Any prior cervical surgeries at the symptomatic levels; prior surgery or cervical fusion procedure at any level.
- Fewer than 2 or more than 2 vertebral levels requiring treatment.
- Anatomy that is non-conducive to receiving investigational device.
- More than one immobile vertebral level between C-1 to C-7 from any cause, including but not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions.
- Known diagnosis of osteoporosis, current pharmacological treatment for osteoporosis or bone density which in the medical opinion of the surgeon precludes operation or contraindicates instrumentation.
- Paget disease, osteomalacia, or any other metabolic bone disease other than osteoporosis.
- Active malignancy that includes a history of any invasive malignancy (except nonmelanoma skin cancer), unless previously treated with curative intent and with no clinical signs or symptoms of the malignancy for \> 5...
- Severe cervical instability based on radiographic exam (whereby an anterior and posterior reconstructive procedure is indicated).
- Decompression requiring corpectomy at one or more levels.
- Active systemic infection or an infection localized to the site of the proposed implantation.
- Open wounds.
- Signs of local inflammation.
- Fever.
- Any diseases or conditions that would preclude accurate clinical evaluation.
- Daily, high-dose oral and/or inhaled steroids or a history of chronic use of high-dose steroids.
- BMI \> 40.
- Use of any other investigational drug or medical device within 30 days prior to surgery.
- Smoking more than 1 pack of cigarettes/day.
- Mental illness that, in the opinion of the investigator, would preclude patient's ability to participate in the study.
- Current or recent history of substance abuse (alcoholism and/or narcotic addiction) requiring intervention.
- Litigation relating to spinal injury/worker's compensation.
- Reported to have a history of or anticipated treatment for active systemic infection, including human immunodeficiency virus (HIV) or Hepatitis C.
- Previous trauma to the C2 to T1 levels resulting in significant bony or disco-ligamentous cervical spine injury.
- Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy or myelopathy justifying the need for surgical intervention.
- Pregnancy.
- Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or...
- Suspected or documented metal allergy or intolerance.
- Inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition.
- Any patient unwilling to cooperate with the post-operative instructions.
- Any time implant utilization would interfere with anatomical structures or expected physiological performance.
The study team makes the final eligibility decision.
Where it's taking place
- Union, New Jersey, United States
- Albany, New York, United States
- Williamsville, New York, United States
- Cleveland, Ohio, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Union, New Jersey, United States; Albany, New York, United States; Williamsville, New York, United States; Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.