Status:
TERMINATED
Novum Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion
Lead Sponsor:
Bio2 Technologies
Collaborating Sponsors:
MCRA
Conditions:
Symptomatic Cervical Disc Disease
Eligibility:
All Genders
22-70 years
Phase:
NA
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 anterio...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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
Key Trial Info
Start Date :
April 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03828136
Start Date
April 24 2019
End Date
March 21 2022
Last Update
April 7 2022
Active Locations (7)
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1
Orthopaedic Education and Research Institute
Orange, California, United States, 92868
2
Hartford Hospital
Hartford, Connecticut, United States, 06102
3
Indiana Spine Group
Carmel, Indiana, United States, 46032
4
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States, 42001