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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
25
For spinal fusion procedure at one level (C3 to T1) of the cervical spine.
Standard of Care
Orthopaedic Education and Research Institute
Orange, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Indiana Spine Group
Carmel, Indiana, United States
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States
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°.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 12 months
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)
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Upstate Medical University
Syracuse, New York, United States
M3-Emerging Medical Research
Durham, North Carolina, United States
Arise Medical Center
Austin, Texas, United States
Time frame: 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).
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)
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".
Time frame: 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.
Time frame: 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".
Time frame: 6, 12, and 24 months