Symptomatic Cervical Disc Disease
Conditions
Keywords
Neck Pain, Arm Pain
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
Interventions
DEVICESECURE-C Cervical Artificial Disc
Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
DEVICEASSURE Cervical plate and an allograft interbody spacer
Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
Sponsors
Globus Medical Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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 * Able to meet the proposed follow-up schedule at 6 weeks, 3 months, 6 months, 12 months and 24 months * Able to follow postoperative management program
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; * A loss of disc height greater than 50%; or * Absence of motion (\<2°) * Neck or arm pain of unknown etiology * Osteoporosis, osteopenia, Paget's disease, osteomalacia or any other metabolic bone disease * Pregnant or interested in becoming pregnant in the next 2 years * Active systemic or local infection * Known allergy to titanium, polyethylene, cobalt, chromium or molybdenum * Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids) * Rheumatoid arthritis or other autoimmune disease * Systemic disease including AIDS, HIV, Hepatitis * Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years * Neuromuscular disorders such as muscular dystrophy, spinal muscular atrophy, amyotrophic lateral sclerosis, etc. * Acute mental illness or substance abuse * Use of bone growth stimulator within past 30 days * Participation in other investigational device or drug clinical trials within 30 days of surgery * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Individual Patient Overall Success | 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
| Measure | Time frame | Description |
|---|---|---|
| Neck Pain Visual Analog Scale (VAS) | 24 months | Improvement of 20mm from baseline in neck pain measured using the Visual Analog Scale (VAS) |
| Left Arm Pain Visual Analog Scale (VAS) | 24 months | Improvement of 20mm from baseline in left arm pain measured using the Visual Analog Scale (VAS) |
| Right Arm Pain Visual Analog Scale (VAS) | 24 months | Improvement of 20mm from baseline in right arm pain measured using the Visual Analog Scale (VAS) |
| Neck Disability Index (NDI) | 24 months | Neck Disability Index (NDI) success defined as ≥25% improvement at 24 months from baseline |
| SF-36 MCS | 24 months | Health Status Survey SF-36 mental composite scores: 15% improvement from baseline |
| Satisfaction | 24 months | Patient satisfaction (definitely/mostly): proportion of patients |
| SF-36 PCS | 24 months | Health Status Survey SF-36 physical composite scores: 15% improvement from baseline |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Randomized SECURE-C Cervical Artificial Disc Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc | 151 |
| ASSURE Cervical Plate and Allograft Interbody Spacer Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion | 140 |
| Non-Randomized SECURE-C Cervical Artificial Disc The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc | 89 |
| Total | 380 |
Baseline characteristics
| Characteristic | Randomized SECURE-C Cervical Artificial Disc | ASSURE Cervical Plate and Allograft Interbody Spacer | Non-Randomized SECURE-C Cervical Artificial Disc | Total |
|---|---|---|---|---|
| Age, Continuous | 43.4 years STANDARD_DEVIATION 7.5 | 44.4 years STANDARD_DEVIATION 7.9 | 41.6 years STANDARD_DEVIATION 8.13 | 43.9 years STANDARD_DEVIATION 7.7 |
| Region of Enrollment United States | 151 participants | 140 participants | 89 participants | 291 participants |
| Sex: Female, Male Female | 70 Participants | 72 Participants | 42 Participants | 184 Participants |
| Sex: Female, Male Male | 81 Participants | 68 Participants | 47 Participants | 196 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 121 / 236 | 80 / 144 |
| serious Total, serious adverse events | 46 / 236 | 34 / 144 |
Outcome results
Primary
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
Population: At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete primary endpoint data was available for 79 Non-randomized SECURE-C patients,141 randomized SECURE-C patients and 114 control patients at 24 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized SECURE-C Cervical Artificial Disc | Individual Patient Overall Success | 127 participants |
| ASSURE Cervical Plate and an Allograft Interbody Spacer | Individual Patient Overall Success | 81 participants |
| Non-Randomized SECURE-C Cervical Artificial Disc | Individual Patient Overall Success | 67 participants |
Secondary
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
Population: At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Left Arm Pain Visual Analog Scale (VAS) data was available for 75 non-randomized SECURE-C, 133 randomized SECURE-C patients and 108 control patients at 24 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized SECURE-C Cervical Artificial Disc | Left Arm Pain Visual Analog Scale (VAS) | 74 participants |
| ASSURE Cervical Plate and an Allograft Interbody Spacer | Left Arm Pain Visual Analog Scale (VAS) | 55 participants |
| Non-Randomized SECURE-C Cervical Artificial Disc | Left Arm Pain Visual Analog Scale (VAS) | 37 participants |
Secondary
Neck Disability Index (NDI)
Neck Disability Index (NDI) success defined as ≥25% improvement at 24 months from baseline
Time frame: 24 months
Population: At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Neck Disability Index (NDI) data was available for 78 Non-randomized SECURE-C patients,139 randomized SECURE-C patients and 116 control patients at 24 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized SECURE-C Cervical Artificial Disc | Neck Disability Index (NDI) | 127 participants |
| ASSURE Cervical Plate and an Allograft Interbody Spacer | Neck Disability Index (NDI) | 101 participants |
| Non-Randomized SECURE-C Cervical Artificial Disc | Neck Disability Index (NDI) | 67 participants |
Secondary
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
Population: At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Neck Pain Visual Analog Scale (VAS) data was available for 75 non-randomized SECURE-C, 133 randomized SECURE-C patients and 108 control patients at 24 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized SECURE-C Cervical Artificial Disc | Neck Pain Visual Analog Scale (VAS) | 104 participants |
| ASSURE Cervical Plate and an Allograft Interbody Spacer | Neck Pain Visual Analog Scale (VAS) | 76 participants |
| Non-Randomized SECURE-C Cervical Artificial Disc | Neck Pain Visual Analog Scale (VAS) | 54 participants |
Secondary
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
Population: At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Right Arm Pain Visual Analog Scale (VAS) data was available for 75 non-randomized SECURE-C patients, 133 randomized SECURE-C patients and 108 control patients at 24 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized SECURE-C Cervical Artificial Disc | Right Arm Pain Visual Analog Scale (VAS) | 57 participants |
| ASSURE Cervical Plate and an Allograft Interbody Spacer | Right Arm Pain Visual Analog Scale (VAS) | 49 participants |
| Non-Randomized SECURE-C Cervical Artificial Disc | Right Arm Pain Visual Analog Scale (VAS) | 36 participants |
Secondary
Satisfaction
Patient satisfaction (definitely/mostly): proportion of patients
Time frame: 24 months
Population: At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Patient Satisfaction data was available for 78 non-randomized SECURE-C patients, 139 randomized SECURE-C patients and 115 control patients at 24 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized SECURE-C Cervical Artificial Disc | Satisfaction | 133 participants |
| ASSURE Cervical Plate and an Allograft Interbody Spacer | Satisfaction | 98 participants |
| Non-Randomized SECURE-C Cervical Artificial Disc | Satisfaction | 72 participants |
Secondary
SF-36 MCS
Health Status Survey SF-36 mental composite scores: 15% improvement from baseline
Time frame: 24 months
Population: At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete SF-36 MCS data was available for 78 non-randomized SECURE-C patients, 138 randomized SECURE-C patients and 114 control patients at 24 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized SECURE-C Cervical Artificial Disc | SF-36 MCS | 70 participants |
| ASSURE Cervical Plate and an Allograft Interbody Spacer | SF-36 MCS | 48 participants |
| Non-Randomized SECURE-C Cervical Artificial Disc | SF-36 MCS | 45 participants |
Secondary
SF-36 PCS
Health Status Survey SF-36 physical composite scores: 15% improvement from baseline
Time frame: 24 months
Population: At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete SF-36 PCS data was available for 78 non-randomized SECURE-C patients, 138 randomized SECURE-C patients and 114 control patients at 24 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized SECURE-C Cervical Artificial Disc | SF-36 PCS | 109 participants |
| ASSURE Cervical Plate and an Allograft Interbody Spacer | SF-36 PCS | 89 participants |
| Non-Randomized SECURE-C Cervical Artificial Disc | SF-36 PCS | 53 participants |