Novum Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion

NCT03828136 | Terminated DMC FDA Device

• 1 other identifier: CT-17-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 7

Brief Summary

A prospective, multicenter, randomized, concurrently controlled, noninferiority clinical trial to compare the safety and effectiveness of instrumented Bio2 Vitrium Cervical Interbody Device in anterior cervical discectomy and fusion (ACDF) with structural allograft bone and local autologous bone graft in treating patients with a symptomatic degenerative cervical disc disease at one level from C3/C4 to C7/T1.

Conditions

Symptomatic Cervical Disc Disease

Keywords

Cervical Disc Disease; ACDF; Single-level

Outcome Measures

Primary Outcomes (4)

• Number of participants who have achieved of radiologic fusion assessed by roentgenographic examination.

  Successful fusion is based on meeting the roentgenographic examination criteria showing the evidence of: bridging trabecular bone between the involved motion segments; translation motion \<3mm; and angular motion ≤2°.

  12 months

• Change in Neck Disability Index (NDI) with a response greater than or equal to 15 from baseline.

  NDI consists of ten items addressing function activities, pain intensity, concentration, and headache.It has a continuous various with a range from 0 (best) to 100 (worse). The effectiveness endpoint is the difference between the baseline value and the follow-up (12 month) value.

  12 months

• Number of participants with neurological success.

  Neurological success is a binary outcome as follows: * Maintenance or improvement of the neurological status; * Worsening of the neurological status. Worsening of the neurological status is defined as permanent new neurologic damage or permanent new nerve root injury related to the surgically treated level, defined as one or more: * Permanent decrease in one or more grades of motor strength compared to baseline; * Permanent new sensory deficit (paresthesia or anesthesia) in a specific cervical nerve root distribution.

  12 months

• Number of participants who have completed follow-up up to month 12 without Secondary Surgical Intervention (SSI).

  Identified as the absence of revision, removal, reoperation, or supplemental fixation at the index level

  12 months

Secondary Outcomes (5)

• Measurement of Pain at neck and at arm and shoulder as assessed by Visual Analog Scale

  6, 12, and 24 months

• Quality of Life assessed by 36-Item Short Form Health Survey Version 2 (SF-36v2)

  6, 12, and 24 months

• Quality of Life assessed by EuroQoL Health Related Quality of Life - 5 Dimensions - 3 Levels (EQ-5D-3L)

  6, 12, and 24 months

• Measurement of the use of Pain Medication for Cervical Spine.

  6, 12, and 24 months

• Measurement of Patient Satisfaction: patients to rate their satisfaction

  6, 12, and 24 months

Study Arms (2)

ACDF with Novum Vitrium® Cervical Interbody Device

EXPERIMENTAL

A resorbable cervical interbody cage.

Device: Novum Vitrium® Cervical Interbody Device

ACDF with Allograft

ACTIVE COMPARATOR

Structural allograft made from structural corticocancellous allograft bone.

Device: Allograft Ring or Block

Interventions

Novum Vitrium® Cervical Interbody Device DEVICE

For spinal fusion procedure at one level (C3 to T1) of the cervical spine.

Also known as: Novum Vitrium® Cervical Cage

ACDF with Novum Vitrium® Cervical Interbody Device

Allograft Ring or Block DEVICE

Standard of Care

ACDF with Allograft

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic cervical disc disease (SCDD) in the one vertebral level between C3/C4 to C7/T1, defined as neck or arm (radicular) pain, or functional or neurological deficit and correlated with radiculopathy or myelopathy or radiographic confirmation (by CT, MRI, x-ray, etc.) of any of the following:
• Herniated nucleus pulposus;
• Spondylosis (defined by the presence of osteophytes); or
• Loss of disc height.
• Requires only one cervical vertebral level to be surgically treated, confirmed radiologically by Xray, CT, or MRI and correlated with neurologic examination prior to enrollment;
• Age between 22 and 70 years (inclusive);
• Skeletally mature patients;
• Failed at least 6 weeks of conservative treatment (e.g. medication, physical therapy), or exhibit progressive symptoms or signs of spinal cord/nerve root compression with continued non-operative care;
• Neck Disability Index (NDI) Questionnaire score of at least 30 (on a scale from 0 to 100);
• Able to read and Understand all documents used in this study, including the Informed Consent and patient-reported outcome questionnaires;
• Understand and read English at elementary level;
• Patient must understand and sign the Informed Consent document that has been approved by the Ethics committee, Institutional review Board and the FDA.

You may not qualify if:

• More than one vertebral level requiring treatment, confirmed radiologically by X-ray, CT, or MRI
• Cervical instability;
• Prior fusion surgery at any cervical vertebral level;
• Prior surgery at the level to be treated with the exception of surgery that does not require the use of hardware and/or the treatment of facet disease;
• Severe facet disease;
• Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma
• Neck or arm pain of unknown etiology;
• Osteoporosis, osteopenia, Paget's disease, osteomalacia or any other metabolic bone disease;
• a. Osteoporosis is defined as history of fragility fracture and Dexa (DXA) T-score \< -2.5 or QCT T-score \< 80mg/cubic cm. History of a fragility fracture requires that a DXA scan or QCT scan is completed
• Pregnant or interested in becoming pregnant in the next 2 years;
• Active systemic or local infection;
• History of severe allergy or anaphylaxis especially to titanium, polyethylene, cobalt, chromium or molybdenum;
• Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids, bisphosphonates);
• Rheumatoid arthritis or another autoimmune disease that affects musculoskeletal system;
• Acquired immune deficiency syndrome (AIDS) or an AIDS-related complex;

Sponsors & Collaborators

• Bio2 Technologies: lead
• MCRA: collaborator

Study Sites (7)

Orthopaedic Education and Research Institute

Orange, California, 92868, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42001, United States

Location

Upstate Medical University

Syracuse, New York, 13210, United States

Location

M3-Emerging Medical Research

Durham, North Carolina, 27704, United States

Location

Arise Medical Center

Austin, Texas, 78746, United States

Location

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A total of 168 patients will be randomized in 7:2 ratio to Investigational (n=130) and Control arms (n=38).

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: February 4, 2019
• Study Start: April 24, 2019
• Primary Completion: March 21, 2022
• Study Completion: March 21, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-03

Locations

US (7)