The NanoStrand Clinical Study

Study Overview
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Brief Summary
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A prospective, multi-center, randomized, self-controlled, single-blinded, clinical study evaluating the NanoMetalene implant as compared to the PEEK and allograft implants in ACDF for the treatment of cervical degenerative disc disease (DDD).

Detailed Description
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PEEK: Polyetheretherketone ACDF: Anterior cervical discectomy and fusion

Official Title
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Comparison of Early Fusion Using a NanoMetalene® Implant Versus Both PEEK and Allograft Implants in Anterior Cervical Discectomy and Fusion (ACDF) With OsteoStrand™ Demineralized Bone Fibers

Conditions
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Disc Degeneration;Cervical

Intervention / Treatment
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* Procedure: Anterior cervical discectomy and fusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cervical degenerative disc disease Requires primary spinal fusion from C3-C7 Minimum of 6 weeks of non-operative treatment Signed informed consent form Exclusion Criteria: Uncontrolled type I or II diabetes mellitus Morbid obesity Documented history of alcohol or drug abuse Fever or leukocytosis Current systemic infection Active malignancy and/or current chemotherapy Known history of osteoporosis Prior fusion or total disc replacement at the operative level or an adjacent level Infection of the operative site Use of implants from other systems Pregnancy Participation in another research study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NanoMetalene/PEEK<br> | Procedure: Anterior cervical discectomy and fusion<br>* primary, 2-level, contiguous<br>|
| Other: NanoMetalene/Allograft<br> | Procedure: Anterior cervical discectomy and fusion<br>* primary, 2-level, contiguous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis | Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary CT Analysis: PEEK | Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis | 12 months | 
| Secondary CT Analysis: Allograft | Proportion of cervical spinal levels for NanoMetalene vs Allograft implants that have achieved fusion as determined by Computed Tomography (CT) analysis | 12 months | 
| Secondary X-Ray Analysis | Proportion of cervical spinal levels for NanoMetalene vs PEEK and Allograft implants that have achieved fusion as determined by x-ray analysis | 24 months | 
| Clinical Outcomes: NDI | Improvement of clinical outcomes (NDI) for all enrolled patients. Improvement is a reduction of scores for all clinical outcomes. Results will be shown as change from baseline to 24 month follow-up. The NDI is an index derived from the Neck Disability Index Pain Questionnaire used by surgeons, clinicians and researchers to quantify disability for neck pain. Scores are from 0-100 and a lower score represents a better score. | 24 months | 
| Clinical Outcomes: VAS Arm | Improvement of clinical outcomes (VAS Arm) for all enrolled patients. Improvement is a reduction of scores for all clinical outcomes. Results will be shown as change from baseline to 24 month follow-up. The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of 0/no pain at all and 100/worst pain imaginable. The study in this scale is used for the worst arm pain. A lower score represents a better score. | 24 months | 
| Clinical Outcomes: VAS Neck | Improvement of clinical outcomes (VAS Neck) for all enrolled patients. Improvement is a reduction of scores for all clinical outcomes. Results will be shown as change from baseline to 24 month follow-up. The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of 0/no pain at all and 100/worst pain imaginable. The study in this scale is used for neck pain. A lower score represents a better score. | 24 months |