RECRUITING

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

Conditions

Neck Pain Spondylosis Spondylosis With Myelopathy Spondylosis With Radiculopathy Spondylosis With Radiculopathy Cervical Region Intervertebral Disc Disorder Cervical Cervical Spondylosis Cervical Myelopathy Cervical Radiculopathy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-03-07

Study Completion:2024-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04883411

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.

Ages Eligible for Study:22 Years to 79 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Eric H Ledet, Ph.D.

CONTACT

5182270743

eledet@revivomedical.com

Principal Investigator

John German, MD

PRINCIPAL_INVESTIGATOR

Albany Medical College

Study Locations (Sites)

IGEA

Union, New Jersey, 07083

United States

Albany Medical College

Albany, New York, 12208

United States

University at Buffalo Neurosurgery

Williamsville, New York, 14221

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: ReVivo Medical, Corp.

John German, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2022-03-07

Study Completion Date2024-06

Study Record Updates

Study Start Date2022-03-07

Study Completion Date2024-06

Terms related to this study

Keywords Provided by Researchers

Cervical Spondylosis
Cervical Myelopathy
Cervical Radiculopathy
Neck Pain

Additional Relevant MeSH Terms

Neck Pain
Spondylosis
Spondylosis With Myelopathy
Spondylosis With Radiculopathy
Spondylosis With Radiculopathy Cervical Region
Intervertebral Disc Disorder Cervical