The purpose of the pivotal IDE clinical study was to evaluate the safety and effectiveness of the SECURE®-C Cervical Artificial Disc for the treatment of symptomatic cervical disc disease at one level between C3 and C7, compared to anterior cervical discectomy and fusion. The purpose of the Postmarket Approval Study is to evaluate the long-term safety and efficacy associated with the use of the SECURE-C Cervical Artificial Disc
Ages Eligible for Study: 18 to 60 years Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
380
Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
Individual Patient Overall Success
Individual patient overall success defined as pain/disability improvement of at least 25% in Neck Disability Index (NDI) compared to baseline; no device failures requiring revision, removal, reoperation, or supplemental fixation; absence of major complications defined as major vessel injury, neurological damage, or nerve injury; and for control fusion patients only, radiographic fusion
Time frame: 24 months
Neck Disability Index (NDI)
Neck Disability Index (NDI) success defined as ≥25% improvement at 24 months from baseline
Time frame: 24 months
Neck Pain Visual Analog Scale (VAS)
Improvement of 20mm from baseline in neck pain measured using the Visual Analog Scale (VAS)
Time frame: 24 months
Left Arm Pain Visual Analog Scale (VAS)
Improvement of 20mm from baseline in left arm pain measured using the Visual Analog Scale (VAS)
Time frame: 24 months
Right Arm Pain Visual Analog Scale (VAS)
Improvement of 20mm from baseline in right arm pain measured using the Visual Analog Scale (VAS)
Time frame: 24 months
SF-36 PCS
Health Status Survey SF-36 physical composite scores: 15% improvement from baseline
Time frame: 24 months
SF-36 MCS
Health Status Survey SF-36 mental composite scores: 15% improvement from baseline
Time frame: 24 months
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Satisfaction
Patient satisfaction (definitely/mostly): proportion of patients
Time frame: 24 months