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

NCT04883411 | Recruiting DMC FDA Device

• 1 other identifier: RM-21-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

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

Keywords

Cervical Spondylosis; Cervical Myelopathy; Cervical Radiculopathy; Neck Pain

Outcome Measures

Primary Outcomes (1)

• Fusion

  Flexion-extension plain radiographs and CT scans will be used to assess bony fusion at both surgical levels.

  24 months.

Secondary Outcomes (1)

• Device-Related Adverse Events

  24 months.

Study Arms (1)

Treatment

EXPERIMENTAL

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

Device: CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System

Interventions

CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System DEVICE

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

Treatment

Eligibility Criteria

• Age: 22 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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 "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.

Sponsors & Collaborators

• ReVivo Medical, Corp.: lead
• Albany Medical College: collaborator
• The Cleveland Clinic: collaborator
• IGEA: collaborator

Study Sites (4)

IGEA

Union, New Jersey, 07083, United States

RECRUITING

Albany Medical College

Albany, New York, 12208, United States

RECRUITING

University at Buffalo Neurosurgery

Williamsville, New York, 14221, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Neck Pain; Spondylosis; Radiculopathy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• John German, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric H Ledet, Ph.D.

CONTACT

5182270743; eledet@revivomedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, first-in-human, multi-center, non-randomized, single arm study.

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 12, 2021
• Study Start: March 7, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)