An interventional study of Anterior cervical discectomy and fusion in Disc Degeneration;Cervical, sponsored by SeaSpine, Inc.. Suspended at 11 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-10-19.
Sponsored by SeaSpine, Inc. · Not applicable, Interventional, and Other
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).
PEEK: Polyetheretherketone ACDF: Anterior cervical discectomy and fusion
464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.
This study's enrollment of 18 is below the median of 60 across 261 interventional studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →SeaSpine, Inc. is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Anterior cervical discectomy and fusion
Procedure: Anterior cervical discectomy and fusion
primary, 2-level, contiguous
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
Time frame: 12 months
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months
Plan to share: No
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This study is suspended, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration→
SeaSpine, Inc.