Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cerv… (NCT01097486) | Clinical Trial Compass
CompletedPhase 2
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy
United States24 participantsStarted 2010-06
Plain-language summary
The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) at 2 or more adjacent cervical vertebral levels between C3-C4 to C7-T1. All subjects in this study will undergo 2 or 3 level anterior cervical discectomy and fusion with anterior cervical plate fixation.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or females between 18 and 70 years of age, inclusive.
✓. Has the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
✓. Has the ability to understand and provide written authorization for the use and disclosure of personal health information (PHI) \[per Health Insurance Portability and Accountability Act (HIPAA) privacy ruling in the US\].
✓. Has a documented symptomatic diagnosis of DDD at C3-C4 to C7-T1.
✓. Has symptomatic radiculopathy and/or myelopathy correlating to radiographic findings of duration of 6 weeks or greater that had failed to respond to non-operative management
✓. Is a candidate for anterior cervical discectomy and fusion in two or three adjacent cervical interbody levels between C3-C4 to C7-T1
✓. Has a stable screening electrocardiogram (ECG), as determined by the investigator that would not preclude surgery.
Exclusion criteria
✕. Female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following surgery.
✕. Has a current or prior history within the last 3 years of neoplasm (excluding basal cell carcinoma) and/or any active neoplasm within the last 24 months, prior to screening.
✕. Has at the time of surgery a systemic or local infection at the site of proposed surgery.
What they're measuring
1
To determine the safety of NeoFuse using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests (hematology, serum chemistry, inflammation, and and immunology).
. Has or is undergoing revision of a prior fusion surgery at any involved level.
✕. Requires ACDF at only one cervical interbody level or more than 3 adjacent cervical interbody levels.
✕. Requires ACDF without the use of an anterior cervical plating system.
✕. Has osteoporosis as defined by a DEXA T score of ≤ -3.0 or a history of fragility fractures or other significant bone disease contraindicating the use of spinal instrumentation.
✕. Has a documented medical history or radiographic evidence of a metabolic bone disease or other condition which would negatively impact the bone healing process.