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

Official title

First-in-human Prospective Study to Assess the Safety and Efficacy of the CEM-Cage and CEM-Plate

Overview

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.

Detailed 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).

Interventions

• Device CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System
  Two-Level ACDF with CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System

Primary outcome measures

• Fusion [Time frame: 24 months.]

Secondary outcome measures (1)

• Device-Related Adverse Events [Time frame: 24 months.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 4 centers

• IGEA — Union
• Albany Medical College — Albany
• University at Buffalo Neurosurgery — Williamsville
• Cleveland Clinic — Cleveland

Identifiers

NCT: NCT04883411 · RM-21-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗