A Prospective Randomized Clinical Investigation of the SECURE-C Cervical Artificial Disc: A Pivotal Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Symptomatic Cervical Disc Disease
- Sponsor
- Globus Medical Inc
- Enrollment
- 380
- Primary Endpoint
- Individual Patient Overall Success
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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
Detailed Description
Ages Eligible for Study: 18 to 60 years Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Investigators
Eligibility Criteria
Inclusion Criteria
- •Symptomatic cervical disc disease (SCDD) in one vertebral level between C3-C7, defined as neck or arm (radicular) pain, or functional or neurological deficit and radiographic confirmation (by CT, MRI, X-ray, etc.) of any of the following:
- •Herniated nucleus pulposus;
- •Radiculopathy or myelopathy;
- •Spondylosis (defined by the presence of osteophytes); or
- •Loss of disc height.
- •Age between 18 and 60 years
- •Failed at least 6 weeks of conservative treatment
- •Neck Disability Index (NDI) Questionnaire score of at least 30 (as percentage of 50 point total)
- •Able to understand and sign informed consent form
- •Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and filling out forms
Exclusion Criteria
- •More than one vertebral level requiring treatment
- •Prior fusion surgery adjacent to the vertebral level being treated
- •Prior surgery at the level to be treated
- •Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma
- •Radiographic confirmation of facet joint disease or degeneration, defined as apparent sclerosis and/or hypertrophy of the facets demonstrated on AP radiographs as a disruption of the normally smooth facet curve
- •Marked cervical instability on resting lateral or flexion/extension radiographs:
- •Translation greater than 3mm, and/or
- •More than 11° of rotational difference from that of either adjacent level.
- •Severe spondylosis at the level to be treated as characterized by any of the following:
- •Bridging osteophytes;
Outcomes
Primary Outcomes
Individual Patient Overall Success
Time Frame: 24 months
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
Secondary Outcomes
- SF-36 MCS(24 months)
- Neck Disability Index (NDI)(24 months)
- Neck Pain Visual Analog Scale (VAS)(24 months)
- Left Arm Pain Visual Analog Scale (VAS)(24 months)
- Satisfaction(24 months)
- Right Arm Pain Visual Analog Scale (VAS)(24 months)
- SF-36 PCS(24 months)