Symptomatic Cervical Disc DiseaseNCT03828136
Novum Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion
A study testing Novum Vitrium® Cervical Interbody Device and Allograft Ring or Block in people with Symptomatic Cervical Disc Disease, run by Bio2 Technologies at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Cervical Disc Disease
- What is being tested?
- Novum Vitrium® Cervical Interbody Device and Allograft Ring or Block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 7 sitesUnited States
- Study dates
- 24 Apr 2019to 21 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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
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- Neck or arm pain of unknown etiology;
- Osteoporosis, osteopenia, Paget's disease, osteomalacia or any other metabolic bone disease;
- 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;
- Active malignancy or history of invasive malignancy within the last five years, except for superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated; patients with carcinoma in situ of the uterine cervix treated definitely more than 1 year prior to enrollment may enter the study;
- Neuromuscular disorders such as muscular dystrophy, spinal muscular atrophy, and amyotrophic lateral sclerosis;
- Pre-existent neurologic or mental disorder which would preclude accurate evaluation and followup (i.e. Alzheimer's disease, Parkinson's disease, unstable psychiatric disorder with hallucinations and/or delusions or schizophrenia);
- Substance use disorder categorized as moderate to severe as defined in DSM-V;
- Mental/Psychiatric disorder as defined in DSM-V;
- Alcohol abuse disorder categorized as moderate to severe as defined in DSM-V;
- Current Smokers;
- Use of bone growth stimulator in the region of the cervical spine within the past 30 days;
- Participation in other investigational device or drug clinical trials within 30 days of surgery;
- Prisoners;
- Morbid obesity, defined as body mass index ("BMI") > 40;
- Type 1 diabetes mellitus requiring daily insulin therapy unless there is documentation of a recent A1c (within 6 months) of less than 7.1 or Type 2 diabetes where the clinical presentation precludes the patient from having surgery;
- Involved in litigation related to the spine;
- On workers compensation
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Arise Medical Center
Austin, Texas, 78746
Indiana Spine Group
Carmel, Indiana, 46032
M3-Emerging Medical Research
Durham, North Carolina, 27704
Hartford Hospital
Hartford, Connecticut, 06102
Orthopaedic Education and Research Institute
Orange, California, 92868
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42001
Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: Safety and Effectiveness of Novum Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion. A Randomized, Controlled, Non-inferiority, Pivotal Study
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.
Read the detailed description
The study will evaluate if Bio2 Vitrium® Cervical Interbody Device (VCIBD) is non-inferior to allograft cage in single-level ACDF with the use of local autologous bone. VCIBD is a restorable cervical interbody cage for the treatment of fusion, following discectomy, of the cervical spine from C3/C4 disc space to the C7/T1 disc space. The material used to manufacture the implant is 13-93 bioactive glass, which is a silicate-based material as described in ASTM F1538-03(R2017). The implant has high porosity and strength and does not contain any biological material or constitute a combination product. The device has a central lumen for packing with autograft. VCIBD is intended to be used with a supplemental fixation system.
The device, when placed between the vertebrae, provides mechanical stability and prevents subsidence prior to bone ingrowth. It restores and maintains the intervertebral space during the fusion process. The porosity and material characteristics provide an osteoconductive matrix that supports bone ingrowth. Additional stabilization is provided by supplemental fixation using anterior cervical plate. The implant incorporates a central lumen, which allows for the cage to be packed with autogenous bone graft.
- Conditions
- Symptomatic Cervical Disc Disease
- Being tested
- Novum Vitrium® Cervical Interbody Device, Allograft Ring or Block
- Keywords
- Cervical Disc Disease, ACDF, Single-level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novum Vitrium® Cervical Interbody DeviceDevice
Also called Novum Vitrium® Cervical Cage
For spinal fusion procedure at one level (C3 to T1) of the cervical spine.
Allograft Ring or BlockDevice
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| ACDF with Novum Vitrium® Cervical Interbody Device | Experimental | A resorbable cervical interbody cage. Receives: Device: Novum Vitrium® Cervical Interbody Device |
| ACDF with Allograft | Active comparator | Structural allograft made from structural corticocancellous allograft bone. Receives: Device: Allograft Ring or Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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°.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 months
Secondary outcomes (5)
Measurement of Pain at neck and at arm and shoulder as assessed by Visual Analog Scale
Neck pain and arm/shoulder pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)
Measured: 6, 12, and 24 months
Quality of Life assessed by 36-Item Short Form Health Survey Version 2 (SF-36v2)
The SF-36v2 Health Survey is a 36-item instrument for measuring health status and outcomes. It yields an eight-scale profile score from the following eight health concepts: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and general mental health (psychological distress and psychological well being). In addition, two composites scores are constructed using factorial modeling, one from physical health composite score (PCS) and one for mental health composite score (MCS).
Measured: 6, 12, and 24 months
Quality of Life assessed by EuroQoL Health Related Quality of Life - 5 Dimensions - 3 Levels (EQ-5D-3L)
The EQ-5D-3L is a standardized instrument used as a measure of health outcomes. It contains questions in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and provides a simple descriptive profile and single index for health status preference. In addition, there is a Visual Analog Scale (VAS). The VAS is the participant's rating of their health on a scale of 0 "worst imaginable health state" to 100 "best imaginable health state".
Measured: 6, 12, and 24 months
Measurement of the use of Pain Medication for Cervical Spine.
The use of prescription and OTC pain medication for cervical spine-related pain will be recorded in addition to the use of opioids on study-specific logs.
Measured: 6, 12, and 24 months
Measurement of Patient Satisfaction: patients to rate their satisfaction
Developed based on IDE spine studies. It asks patients to rate their satisfaction with their treatment (6 choices from "Very Satisfied" to "Very Dissatisfied"), and question regarding every day activities and their ability to complete them. There are 5 choices from "Definitely" to "Definitely Not".
Measured: 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start24 Apr 2019
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
Why it stopped: Sponsor business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Cervical Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 168 patients will be randomized in 7:2 ratio to Investigational (n=130) and Control arms (n=38).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio2 Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828136
- Sponsor's protocol ID
- CT-17-001
- Status last verified
- Mar 2022
- First submitted
- 25 Jan 2019
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Novum Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion. A Randomized, Controlled, Non-inferiority, Pivotal Study
- ClinicalTrials.gov ID
- NCT03828136
- Acronym / sponsor ID
- CT-17-001
- Conditions
- Symptomatic Cervical Disc Disease
- Keywords
- Cervical Disc Disease, ACDF, Single-level
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor business decision
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bio2 TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will evaluate if Bio2 Vitrium® Cervical Interbody Device (VCIBD) is non-inferior to allograft cage in single-level ACDF with the use of local autologous bone. VCIBD is a restorable cervical interbody cage for the treatment of fusion, following discectomy, of the cervical spine from C3/C4 disc space to the C7/T1 disc space. The material used to manufacture the implant is 13-93 bioactive glass, which is a silicate-based material as described in ASTM F1538-03(R2017). The implant has high porosity and strength and does not contain any biological material or constitute a combination product. The device has a central lumen for packing with autograft. VCIBD is intended to be used with a supplemental fixation system.
The device, when placed between the vertebrae, provides mechanical stability and prevents subsidence prior to bone ingrowth. It restores and maintains the intervertebral space during the fusion process. The porosity and material characteristics provide an osteoconductive matrix that supports bone ingrowth. Additional stabilization is provided by supplemental fixation using anterior cervical plate. The implant incorporates a central lumen, which allows for the cage to be packed with autogenous bone graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A total of 168 patients will be randomized in 7:2 ratio to Investigational (n=130) and Control arms (n=38).
| Arm | Type | Receives |
|---|---|---|
| ACDF with Novum Vitrium® Cervical Interbody Device | Experimental | Device: Novum Vitrium® Cervical Interbody DeviceA resorbable cervical interbody cage. |
| ACDF with Allograft | Active comparator | Device: Allograft Ring or BlockStructural allograft made from structural corticocancellous allograft bone. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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;
Key exclusion criteria (29 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novum Vitrium® Cervical Interbody DeviceAlso: Novum Vitrium® Cervical CageFor spinal fusion procedure at one level (C3 to T1) of the cervical spine. | Device | ACDF with Novum Vitrium® Cervical Interbody Device |
| Allograft Ring or BlockStandard of Care | Device | ACDF with Allograft |
Primary outcome
Number of participants who have achieved of radiologic fusion assessed by roentgenographic examination.
Time frame: 12 months
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°.
Change in Neck Disability Index (NDI) with a response greater than or equal to 15 from baseline.
Time frame: 12 months
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.
Number of participants with neurological success.
Time frame: 12 months
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.
Number of participants who have completed follow-up up to month 12 without Secondary Surgical Intervention (SSI).
Time frame: 12 months
Identified as the absence of revision, removal, reoperation, or supplemental fixation at the index level
5 secondary outcomes
Measurement of Pain at neck and at arm and shoulder as assessed by Visual Analog Scale
Time frame: 6, 12, and 24 months
Quality of Life assessed by 36-Item Short Form Health Survey Version 2 (SF-36v2)
Time frame: 6, 12, and 24 months
Quality of Life assessed by EuroQoL Health Related Quality of Life - 5 Dimensions - 3 Levels (EQ-5D-3L)
Time frame: 6, 12, and 24 months
Measurement of the use of Pain Medication for Cervical Spine.
Time frame: 6, 12, and 24 months
Measurement of Patient Satisfaction: patients to rate their satisfaction
Time frame: 6, 12, and 24 months
Results and safety
The study was stopped early (reason given: Sponsor business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novum Vitrium® Cervical Interbody Device and Allograft Ring or Block in people with Symptomatic Cervical Disc Disease, run by Bio2 Technologies at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who have achieved of radiologic fusion assessed by roentgenographic examination. (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.