Degenerative Disc Disease
Conditions
Keywords
degenerative disc disease, cervical arthroplasty, Mobi C, multilevel, anterior cervical discectomy and fusion
Brief summary
The purpose of this investigation is to establish the safety and effectiveness of the LDR Spine Mobi-C® Cervical Disc Prosthesis which is an anterior cervical interbody mechanical device. The primary objective of the study is to evaluate the overall success rate of the investigational device as compared to the control in the treatment of patients with symptomatic DDD with radiculopathy or myeloradiculopathy at one or two adjacent levels. Patients should be without prior cervical fusion between C3 and C7 and unresponsive to non-operative conservative treatment for six weeks after symptom onset or have the presence of progressive symptoms or signs of nerve/spinal cord compression despite continued non-operative conservative treatment.
Detailed description
Objectives of the Investigation The purpose of this investigation is to establish the safety and effectiveness of the LDR Spine Mobi-C® Cervical Disc Prosthesis which is an anterior cervical interbody mechanical device. The primary objective of the study is to evaluate the overall success rate of the investigational device as compared to the control in the treatment of patients with symptomatic DDD with radiculopathy or myeloradiculopathy at one or two adjacent levels. Patients should be without prior cervical fusion between C3 and C7 and unresponsive to non-operative conservative treatment for six weeks after symptom onset or have the presence of progressive symptoms or signs of nerve/spinal cord compression despite continued non-operative conservative treatment. Study Design Rationale The study is a prospective, randomized, multi-center, concurrently controlled investigation, in which the study device will be compared to the control treatment consisting of conventional anterior cervical discectomy and fusion (ACDF) in accordance with the Smith-Robinson procedure. Patients will be followed for two years postsurgery (primary endpoint) and at 3, 4, 5, and 7 years thereafter. Duration of the Investigation Patients will be followed post-operatively at 6 weeks, and 3-, 6-, 12-, 18-, and 24-months. After 24 months, patients will continue to be followed at 3,4, 5 and 7 years. Design Techniques to Avoid Bias To eliminate selection bias, investigational and control comparison groups will be assigned at random. Institutional Review Board No clinical studies will begin without documented approval of the clinical investigation by the Institutional Review Board (IRB) affiliated with the study center.
Interventions
DEVICECervical Artificial Disc
Cervical artificial disc mechanical device
Sponsors
LDR Spine USA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-69 years. 2. Diagnosis of radiculopathy or myeloradiculopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following: * Neck and/or arm pain (at least 30mm on the 100mm VAS scale). * Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale. * Abnormal sensation including hyperesthesia or hypoesthesia; and/or * Abnormal reflexes 3. Symptomatic at one or two adjacent levels from C3 to C7; 4. Radiographically determined pathology at one or two adjacent level(s) to be treated correlating to primary symptoms including at least one of the following: * Decreased disc height on radiography, CT, or MRI in comparison to a normal adjacent disc. * Degenerative spondylosis on CT or MRI. * Disc herniation on CT or MRI; 5. Neck Disability Index Score of ≥15/50 or ≥30%; 6. Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for: * Approximately six weeks from radiculopathy or myeloradiculopathy symptom onset; or * Have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative conservative treatment. Note: Not a complete listing
Exclusion criteria
1. Reported to have an active systemic infection or infection at the operative site; 2. Reported to have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C; 3. More than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic spontaneous fusions; 4. Previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury; 5. Reported to have had any prior spine surgery at the operative level; 6. Reported to have had prior cervical fusion procedure at any level; 7. Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention; 8. Disc height less than 3mm as measured from the center of the disc in a neutral position and disc height less than 20% of the anterior-posterior width of the inferior vertebral body; 9. Radiographic confirmation of severe facet joint disease or degeneration; Note: Not a complete listing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Definition of Study Success | 2 Years | An individual subject in either treatment group was considered a success if the following criteria were met at 24 months: * Improvement in Neck Disability Index of at least 15/50 points in subjects with baseline Neck Disability Index scores of \>= 30/50 points, or a 50% improvement in subjects with a baseline Neck Disability Score score of \<30/50 where the Neck Disability Index is a measure designed to enable the physician to understand how much a subject's neck pain has affected his ability to manage everyday activities. * No study failures due to secondary surgical interventions at the index level * Absence of major complications defined as radiographic failure, neurologic failure, or failure by adverse event as adjudicated by the CEC |
Countries
United States
Participant flow
Recruitment details
One Level TDR Arm: 169 subjects randomized (5 not operated) One Level ACDF Arm: 87 subjects randomized (6 not operated) Two level TDR arm: 232 subjects randomized (7 not operated). Two Level ACDF Arm: 115 subjects randomized (10 not operated)
Pre-assignment details
1 level TDR enrolled 184 incl15 training cases (2 withdrew consent, 1 AE, 2 other). 1 level ACDF enrolled 87 with no training cases (4 withdrew consent, 2 other) for 245 randomized subjects. 2 level TDR enrolled 241 incl. 9 training cases (1 withdrew consent, 6 other); 2 Level ACDF enrolled 115 with no training cases (4 withdrew consent, 6 other)
Participants by arm
| Arm | Count |
|---|---|
| 1 Level TDR Cervical artificial disc (investigational device) at 1 level | 164 |
| 1 Level ACDF 1 level control procedure (ACDF) | 81 |
| 2 Level TDR Cervical artificial disc (investigational device) at 2 levels | 225 |
| 2 Level ACDF 2 level control procedure (ACDF) | 105 |
| Total | 575 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 6 | 4 | 6 |
Baseline characteristics
| Characteristic | 1 Level TDR | 1 Level ACDF | 2 Level TDR | 2 Level ACDF | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 3 Participants | 4 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 161 Participants | 80 Participants | 222 Participants | 101 Participants | 564 Participants |
| Region of Enrollment United States | 164 participants | 81 participants | 225 participants | 105 participants | 575 participants |
| Sex: Female, Male Female | 86 Participants | 45 Participants | 112 Participants | 45 Participants | 288 Participants |
| Sex: Female, Male Male | 78 Participants | 36 Participants | 113 Participants | 60 Participants | 287 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 170 / 179 | 75 / 81 | 209 / 234 | 100 / 105 |
| serious Total, serious adverse events | 32 / 179 | 21 / 81 | 56 / 234 | 34 / 105 |
Outcome results
Primary
Composite Definition of Study Success
An individual subject in either treatment group was considered a success if the following criteria were met at 24 months: * Improvement in Neck Disability Index of at least 15/50 points in subjects with baseline Neck Disability Index scores of \>= 30/50 points, or a 50% improvement in subjects with a baseline Neck Disability Score score of \<30/50 where the Neck Disability Index is a measure designed to enable the physician to understand how much a subject's neck pain has affected his ability to manage everyday activities. * No study failures due to secondary surgical interventions at the index level * Absence of major complications defined as radiographic failure, neurologic failure, or failure by adverse event as adjudicated by the CEC
Time frame: 2 Years
Population: includes study failures, per protocol, that are carried forward for overall success
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 Level ACDF | Composite Definition of Study Success | 65.3 percentage of subjects analyzed |
| 1 Level TDR | Composite Definition of Study Success | 73.7 percentage of subjects analyzed |
| 2 Level ACDF | Composite Definition of Study Success | 37.4 percentage of subjects analyzed |
| 2 Level TDR | Composite Definition of Study Success | 69.7 percentage of subjects analyzed |
Comparison: 1 Level: Ho: pm-pc \<=-0.1 (inferiority) Alternative hypothesis: Ha: pm - pc \> -0.1 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group.p-value: 0.0021Farrington Manning
Comparison: 2 Level: Ho: pm-pc \<=-0.1 (inferiority) Alternative hypothesis: Ha: pm - pc \> -0.1 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group.~2 Level: Ho: pm-pc \<= 0 (not superior) Alternative hypothesis: Ha: pm-pc \>0 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group.p-value: <0.0001Farrington-Manning