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Bio2 Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion

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ClinicalTrials.gov Identifier: NCT03828136
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : May 9, 2019
Sponsor:
Collaborator:
Musculoskeletal Clinical Regulatory Advisers
Information provided by (Responsible Party):
Bio2 Technologies

Tracking Information
First Submitted Date  ICMJE January 25, 2019
First Posted Date  ICMJE February 4, 2019
Last Update Posted Date May 9, 2019
Actual Study Start Date  ICMJE April 24, 2019
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03828136 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
  • Measurement of Pain at neck and at arm and shoulder as assessed by Visual Analog Scale [ Time Frame: 6, 12, and 24 months ]
    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)
  • Quality of Life assessed by 36-Item Short Form Health Survey Version 2 (SF-36v2) [ Time Frame: 6, 12, and 24 months ]
    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).
  • 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 ]
    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".
  • Measurement of the use of Pain Medication for Cervical Spine. [ Time Frame: 6, 12, and 24 months ]
    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.
  • Measurement of Patient Satisfaction: patients to rate their satisfaction [ Time Frame: 6, 12, and 24 months ]
    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".
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • Measurement of Pain at neck and at arm and shoulder as assessed by Visual Analog Scale [ Time Frame: 6, 12, and 24 months ]
    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)
  • Quality of Life assessed by SF-36v2 scale. [ Time Frame: 6, 12, and 24 months ]
    The SF-36v2 is a multipurpose, patient-reported short-form health survey 36 questions. It yields an eight-scale profile of scores. 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).
  • Quality of Life assessed by EQ-5D-3L [ Time Frame: 6, 12, and 24 months ]
    The EQ-5D-3L is a standardized instrument used as a measure of health outcomes. It contains 5 questions and provides a simple descriptive profile and single index for health status preference.
  • Measurement of the use of Pain Medication for Cervical Spine. [ Time Frame: 6, 12, and 24 months ]
    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.
  • Measurement of Patient Satisfaction: patients to rate their satisfaction [ Time Frame: 6, 12, and 24 months ]
    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".
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bio2 Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion
Official Title  ICMJE Safety and Effectiveness of Bio2 Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion. A Randomized, Controlled, Non-inferiority, Pivotal Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Primary Purpose: Treatment
Condition  ICMJE Symptomatic Cervical Disc Disease
Intervention  ICMJE
  • Device: Bio2 Vitrium® Cervical Interbody Device
    For spinal fusion procedure at one level (C3 to T1) of the cervical spine.
    Other Name: Bio2 Vitrium® Cervical Cage
  • Device: Allograft Cage
    Standard of Care
Study Arms  ICMJE
  • Experimental: ACDF with Bio2 Vitrium® Cervical Interbody Device
    A resorbable cervical interbody cage.
    Intervention: Device: Bio2 Vitrium® Cervical Interbody Device
  • Active Comparator: ACDF with Allograft Cage
    Structural allograft ring made from structural corticocancellous allograft bone.
    Intervention: Device: Allograft Cage
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2019)
168
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2024
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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);
  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;
  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 within 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. Severe diabetes mellitus requiring daily insulin therapy (i.e., Hemoglobin H1c levels of >7.0% if subject is a diagnosed diabetic. Hemoglobin H1c levels must be within 6 months of date of screening/baseline visit.)
  27. Involved in litigation related to the spine;
  28. On workers compensation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Janet Krevolin 781-569-0559 janet@bio2tech.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03828136
Other Study ID Numbers  ICMJE CT-17-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bio2 Technologies
Study Sponsor  ICMJE Bio2 Technologies
Collaborators  ICMJE Musculoskeletal Clinical Regulatory Advisers
Investigators  ICMJE Not Provided
PRS Account Bio2 Technologies
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP