Cervicobrachial Syndrome, Myelopathy, Radiating Pain
Conditions
Keywords
Cervicobrachial pain, radicular pain, arm pain, myelopathy, radiculitis, Radiating pain with or without signs of myelopathy.
Brief summary
This study randomizes neck and arm pain patients being treated with discectomy and anterior interbody fusion into two groups: one to receive a new ceramic implant and a control group with a more traditional plastic implant. The study will measure and compare pain and disability improvement with the two products over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.
Interventions
DEVICEAnterior cervical discectomy and fusion (ACDF) with PEEK Cage
Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer
DEVICEAnterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage
Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer.
Sponsors
Amedica Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 75 years * Radicular signs and symptoms in one or both arms (i.e., pain, paraesthesiae or paresis in a specific nerve root distribution) or symptoms and signs of acute or chronic myelopathy. * At least 8 weeks prior conservative treatment (i.e., physical therapy, pain medication) * Radiographic diagnosis of cervical disc herniation and/or osteophyte at 1 level (C3-C4 to C7-T1) in accordance with clinical signs and symptoms * Ability and willingness to comply with project requirements * Written informed consent given by the subject or the subject's legally authorised representative
Exclusion criteria
* Previous cervical surgery (either anterior or posterior) * Increased motion on dynamic studies (\> 3 mm) * Severe segmental kyphosis of the involved disc level (\> 7 degrees) * Patient cannot be imaged with MRI * Neck pain only (without radicular or medullary symptoms) * Infection * Metabolic and bone diseases (osteoporosis, severe osteopenia) * Neoplasma or trauma of the cervical spine * Spinal anomaly (Klippel Feil, Bechterew, OPLL) * Severe mental or psychiatric disorder * Inadequate Dutch language * Planned (e)migration abroad in the year after inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck Disability Index | 24 months post-op | The change in the Neck Disability Index compared to the pre-op value for each group will be compared. Neck disability index is a unitless measure from zero (no disability) to 100 (absolute disability). Change is calculated as the pre-op value minus the 24 month value. A negative difference indicates that the patient is more disabled at 24 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fusion Status | 3 mo., 6mo., 12 mo., 24 months | Dynamic flexion-extension plane film x-rays will be used to assess fusion at all four follow-up periods. The criteria for fusion are rotation motion less than or equal to four degrees and translation less than 1.25 mm. The final fusion judgement will be fusion status at 24 months or the last time point with flexion-extension data available. |
Countries
Netherlands
Participant flow
Recruitment details
The study was designed as double-blind randomized trial. The design called for randomizing 100 patients.
Pre-assignment details
Four additional patients were randomized when four patients were excluded for protocol violations prior to the primary endpoint. A surgeon who had not been trained as an investigator operated on these four patients, making numerous protocol violations in implant technique. These patients were randomized and had pre-op data in the study.
Participants by arm
| Arm | Count |
|---|---|
| ACDF With Valeo CSC Ceramic Cage ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage. | 53 |
| ACDF With PEEK Interbody Cage Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic. | 51 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Protocol Violation | 1 | 3 |
Baseline characteristics
| Characteristic | ACDF With PEEK Interbody Cage | Total | ACDF With Valeo CSC Ceramic Cage |
|---|---|---|---|
| Age, Continuous | 49.6 years STANDARD_DEVIATION 9.5 | 51.3 years STANDARD_DEVIATION 9.5 | 53.3 years STANDARD_DEVIATION 9.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Netherlands | 51 participants | 104 participants | 53 participants |
| Sex: Female, Male Female | 25 Participants | 52 Participants | 27 Participants |
| Sex: Female, Male Male | 26 Participants | 52 Participants | 26 Participants |
| Symptomatic (operated) spinal level C3-C4 | 1 Participants | 2 Participants | 1 Participants |
| Symptomatic (operated) spinal level C4-C5 | 6 Participants | 6 Participants | 0 Participants |
| Symptomatic (operated) spinal level C5-C6 | 30 Participants | 60 Participants | 30 Participants |
| Symptomatic (operated) spinal level C6-C7 | 12 Participants | 32 Participants | 20 Participants |
| Symptomatic (operated) spinal level C7-T1 | 2 Participants | 4 Participants | 2 Participants |
| Use of nicotine products | 20 Participants | 43 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 53 | 11 / 51 |
| serious Total, serious adverse events | 2 / 53 | 1 / 51 |
Outcome results
Primary
Neck Disability Index
The change in the Neck Disability Index compared to the pre-op value for each group will be compared. Neck disability index is a unitless measure from zero (no disability) to 100 (absolute disability). Change is calculated as the pre-op value minus the 24 month value. A negative difference indicates that the patient is more disabled at 24 months.
Time frame: 24 months post-op
Population: Patients who had data from 24 month follow-up visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACDF With Valeo CSC Ceramic Cage | Neck Disability Index | 17.9 units on a scale from 0 to 100 | Standard Deviation 14.9 |
| ACDF With PEEK Interbody Cage | Neck Disability Index | 16.7 units on a scale from 0 to 100 | Standard Deviation 16.1 |
Comparison: The null hypothesis was that the mean change in NDI scores from pre-op to 24 months was equal in the two study arms.p-value: 0.64195% CI: [-7.3, 4.5]Fisher Exact
Secondary
Fusion Status
Dynamic flexion-extension plane film x-rays will be used to assess fusion at all four follow-up periods. The criteria for fusion are rotation motion less than or equal to four degrees and translation less than 1.25 mm. The final fusion judgement will be fusion status at 24 months or the last time point with flexion-extension data available.
Time frame: 3 mo., 6mo., 12 mo., 24 months
Population: Patients with 24 month films
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ACDF With Valeo CSC Ceramic Cage | Fusion Status | 40 Participants |
| ACDF With PEEK Interbody Cage | Fusion Status | 37 Participants |
Comparison: The null hypothesis was that the fusion rates would be equal in the two study arms. The comparison includes patients with flexion-extension films at 24 months (as-treated population).p-value: 0.71Fisher Exact