Clinical trial NCT03828136: Novum Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion
Official title: Safety and Effectiveness of Novum Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion. A Randomized, Controlled, Non-inferiority, Pivotal Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Symptomatic Cervical Disc Disease
Keywords: Cervical Disc Disease
ACDF
Single-level
Lead sponsor: Bio2 Technologies
Sponsor class: INDUSTRY
Collaborators: name: MCRA
First posted: 2019-02-04
Enrollment: 25
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 168 patients will be randomized in 7:2 ratio to Investigational (n=130) and Control arms (n=38).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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;
3. Age between 22 and 70 years (inclusive);
4. Skeletally mature patients;
5. 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;
6. Neck Disability Index (NDI) Questionnaire score of at least 30 (on a scale from 0 to 100);
7. Able to read and Understand all documents used in this study, including the Informed Consent and patient-reported outcome questionnaires;
8. Understand and read English at elementary level;
9. Patient must understand and sign the Informed Consent document that has been approved by the Ethics committee, Institutional review Board and the FDA.

Exclusion Criteria:

1. More than one vertebral level requiring treatment, confirmed radiologically by X-ray, CT, or MRI
2. Cervical instability;
3. Prior fusion surgery at any cervical vertebral level;
4. 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;
5. Severe facet disease;
6. Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma
7. Neck or arm pain of unknown etiology;
8. 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
9. Pregnant or interested in becoming pregnant in the next 2 years;
10. Active systemic or local infection;
11. History of severe allergy or anaphylaxis especially to titanium, polyethylene, cobalt, chromium or molybdenum;
12. Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids, bisphosphonates);
13. Rheumatoid arthritis or another autoimmune disease that affects musculoskeletal system;
14. Acquired immune deficiency syndrome (AIDS) or an AIDS-related complex;
15. 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;
16. Neuromuscular disorders such as muscular dystrophy, spinal muscular atrophy, and amyotrophic lateral sclerosis;
17. 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);
18. Substance use disorder categorized as moderate to severe as defined in DSM-V;
19. Mental/Psychiatric disorder as defined in DSM-V;
20. Alcohol abuse disorder categorized as moderate to severe as defined in DSM-V;
21. Current Smokers;
22. Use of bone growth stimulator in the region of the cervical spine within the past 30 days;
23. Participation in other investigational device or drug clinical trials within 30 days of surgery;
24. Prisoners;
25. Morbid obesity, defined as body mass index ("BMI") \> 40;
26. 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;
27. Involved in litigation related to the spine;
28. On workers compensation

Primary outcomes:
measure: Number of participants who have achieved of radiologic fusion assessed by roentgenographic examination.
timeFrame: 12 months
measure: Change in Neck Disability Index (NDI) with a response greater than or equal to 15 from baseline.
timeFrame: 12 months
measure: Number of participants with neurological success.
timeFrame: 12 months
measure: Number of participants who have completed follow-up up to month 12 without Secondary Surgical Intervention (SSI).
timeFrame: 12 months
Secondary outcomes:
measure: Measurement of Pain at neck and at arm and shoulder as assessed by Visual Analog Scale
timeFrame: 6, 12, and 24 months
measure: Quality of Life assessed by 36-Item Short Form Health Survey Version 2 (SF-36v2)
timeFrame: 6, 12, and 24 months
measure: Quality of Life assessed by EuroQoL Health Related Quality of Life - 5 Dimensions - 3 Levels (EQ-5D-3L)
timeFrame: 6, 12, and 24 months
measure: Measurement of the use of Pain Medication for Cervical Spine.
timeFrame: 6, 12, and 24 months
measure: Measurement of Patient Satisfaction: patients to rate their satisfaction
timeFrame: 6, 12, and 24 months
Other outcomes:
Locations:
city: Orange
country: United States
facility: Orthopaedic Education and Research Institute
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Paducah
country: United States
facility: Orthopaedic Institute of Western Kentucky
state: Kentucky
city: Syracuse
country: United States
facility: Upstate Medical University
state: New York
city: Durham
country: United States
facility: M3-Emerging Medical Research
state: North Carolina
city: Austin
country: United States
facility: Arise Medical Center
state: Texas
Study officials:
References: