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

November 1, 2023 updated by: ReVivo Medical, Corp.

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

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.

Study Overview

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).

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • New Jersey
      • Union, New Jersey, United States, 07083
        • Recruiting
        • IGEA
        • Contact:
          • Adam Lipson, MD
        • Principal Investigator:
          • Adam Lipson, MD
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical College
        • Contact:
          • John German, MD
        • Sub-Investigator:
          • Darryl DiRisio, MD
        • Sub-Investigator:
          • Robert Cheney, MD
        • Principal Investigator:
          • John German, MD
        • Sub-Investigator:
          • John Dalfino, MD
        • Sub-Investigator:
          • Frank Genovese, MD
      • Williamsville, New York, United States, 14221
        • Recruiting
        • University at Buffalo Neurosurgery
        • Contact:
          • John Pollina, MD
        • Principal Investigator:
          • John Pollina, MD
        • Sub-Investigator:
          • Jeffrey Mullin, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Sub-Investigator:
          • Michael Steinmetz, MD
        • Contact:
          • Dominic Pelle, MD
        • Principal Investigator:
          • Dominic Pelle, MD
        • Sub-Investigator:
          • Iain Kalfas, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Males and females aged 22-79 years.
  2. Documented diagnosis of cervical spine radiculopathy or myelopathy.
  3. Symptomatic cervical degenerative disc disease at 2 contiguous levels between C2 through T1.
  4. Baseline NDI score ≥30 and/or baseline mJOA score ≤16.
  5. 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).
  6. 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.
  7. Ability to speak, read, and understand the IRB approved Informed Consent document.
  8. Willingness to give informed consent for participation in the study.

Exclusion Criteria:

  1. Any prior cervical surgeries at the symptomatic levels; prior surgery or cervical fusion procedure at any level.
  2. Fewer than 2 or more than 2 vertebral levels requiring treatment.
  3. Anatomy that is non-conducive to receiving investigational device.
  4. 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.
  5. 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.
  6. Paget disease, osteomalacia, or any other metabolic bone disease other than osteoporosis.
  7. 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.
  8. Severe cervical instability based on radiographic exam (whereby an anterior and posterior reconstructive procedure is indicated).
  9. Decompression requiring corpectomy at one or more levels.
  10. Active systemic infection or an infection localized to the site of the proposed implantation.
  11. Open wounds.
  12. Signs of local inflammation.
  13. Fever.
  14. Any diseases or conditions that would preclude accurate clinical evaluation.
  15. Daily, high-dose oral and/or inhaled steroids or a history of chronic use of high-dose steroids.
  16. BMI > 40.
  17. Use of any other investigational drug or medical device within 30 days prior to surgery.
  18. Smoking more than 1 pack of cigarettes/day.
  19. Mental illness that, in the opinion of the investigator, would preclude patient's ability to participate in the study.
  20. Current or recent history of substance abuse (alcoholism and/or narcotic addiction) requiring intervention.
  21. Litigation relating to spinal injury/worker's compensation.
  22. Reported to have a history of or anticipated treatment for active systemic infection, including human immunodeficiency virus (HIV) or Hepatitis C.
  23. Previous trauma to the C2 to T1 levels resulting in significant bony or disco-ligamentous cervical spine injury.
  24. Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy or myelopathy justifying the need for surgical intervention.
  25. Pregnancy.
  26. 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.
  27. Suspected or documented metal allergy or intolerance.
  28. Inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition.
  29. Any patient unwilling to cooperate with the post-operative instructions.
  30. Any time implant utilization would interfere with anatomical structures or expected physiological performance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Two-Level ACDF with 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fusion
Time Frame: 24 months.
Flexion-extension plain radiographs will be used to assess bony fusion at both surgical levels.
24 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device-Related Adverse Events
Time Frame: 24 months.
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.
24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: John German, MD, Albany Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neck Pain

Clinical Trials on CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System

3
Subscribe