CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study

  • STATUS
    Recruiting
  • End date
    Jun 10, 2024
  • participants needed
    50
  • sponsor
    ReVivo Medical, Corp.
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Updated on 10 May 2022
See if I qualify
spinal cord
radiculopathy

Summary

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.

Description

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.

The study consists of a screening period, surgical procedure, and 6 post-operative visits. At each indicated visit, quality of life scales and adverse events will be collected. In addition, at 4 weeks post-operatively, patients will undergo static lateral cervical plain x rays to assess implant positioning and integrity. At 3 months, 6 months, 12 months, 18 months, and 24 months, patients will undergo flexion/extension and neutral lateral plain radiographs to assess overall success and fusion.

The study has co-primary endpoints for efficacy (fusion) and overall success where overall success is defined as fusion, device implanted as intended, no serious adverse events related to the surgical procedure, no device-related serious adverse events, no subsequent surgical interventions at the index levels, and absence of clinically significant device malfunctions. Fusion data will be compared to benchmark data (Davis et al, 2013, control arm of the 2-level Mobi-C IDE study).

Details
Condition Neck Pain, Spondylosis, Spondylosis With Myelopathy, Spondylosis With Radiculopathy, Spondylosis With Radiculopathy Cervical Region, Intervertebral Disc Disorder Cervical
Treatment CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System
Clinical Study IdentifierNCT04883411
SponsorReVivo Medical, Corp.
Last Modified on10 May 2022

Eligibility

 Yes No Not Sure

Inclusion 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 treatment
Ability to speak, read, and understand the IRB approved Informed Consent document
Willingness to give informed consent for participation in the study

Exclusion Criteria

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 years
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 a marked left shift in the WBC differential count
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
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