Degenerative Disc Disease
Conditions
Keywords
Prospective, Degenerative Disc Disease, Cervical, Translational Plate
Brief summary
The purpose of this study is to measure the benefits of anterior (from the front) cervical (neck) surgery for degenerative disc disease. The research part of this study is the answering of questionnaires by the patient concerning their quality of life, prior to, and after surgery.
Detailed description
This is a prospective, multi-center, four-arm study designed to evaluate the clinical and radiographic outcomes in patients diagnosed with cervical degenerative disc disease (DDD) and treated using the Vectra-T Cervical Plate and the Advanced ACF or CorticoCancellous Allograft Spacer made by Synthes Spine Company (Paoli, PA). This is not an investigational study (IDE) and no investigational or experimental devices or procedures are included in this study.
Interventions
DEVICEVectra-T
Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
Sponsors
Synthes USA HQ, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* One to four levels (consecutive) cervical degenerative disc disease between C2 and C7, defined as at least one of the following: * disc herniation * axial neck pain (with or without radiculopathy or myelopathy) caused by spondylosis * functional deficit * neurological deficit which significantly limits patient's normal living * One to four cervical levels to be plated * Patient is skeletally mature and at least 18 years of age * Patient signs consent form * Patient is available for long term (24 month) follow-up * Etiology must be confirmed by MRI or CT
Exclusion criteria
* Spondylolisthesis greater than grade 1 at either level(s) to be instrumented * Indications for complete corpectomy of any involved levels * Posterior instrumentation is necessary at same levels * More than one previous failed anterior fusion attempt at the involved level(s) * Has had more than one previous open, posterior, spine surgical procedures at the involved level(s) or pre-op instability on Flexion/Extension radiographs. * Pregnant or interested in becoming pregnant during the study follow-up period * Has a known sensitivity to device materials * Mentally incompetent or prisoner * Currently a participant in a study related to the treatment of cervical spinal disorders * Pre-op instability\>3mm on flexion/extension X-rays
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Fusion | 24 Months | Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neck Disability Index (NDI) is a Widely Used Instrument for Assessing Self-reported Disability in Patients With Neck Pain. Scoring is Reported on a 0-100 Point Scale, 0 Being the Best Possible Score and 100 Being the Worst Possible Score | 24 Months | Average NDI score at 24 months - score range is 0 to 100, with 0 being the best and 100 being the worst |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1-level Patients needing a single level cervical fusion with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels) | 89 |
| 2-level Patients needing cervical fusion at two consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels) | 88 |
| 3-level Patients needing cervical fusion at three consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels) | 48 |
| 4-level Patients needing cervical fusion at four consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels) | 6 |
| Total | 231 |
Baseline characteristics
| Characteristic | 1-level | 2-level | 3-level | 4-level | Total |
|---|---|---|---|---|---|
| Age, Continuous | 46.8 years STANDARD_DEVIATION 10.58 | 50.3 years STANDARD_DEVIATION 9.6 | 55.8 years STANDARD_DEVIATION 11.4 | 56.4 years STANDARD_DEVIATION 12.1 | 50.8 years STANDARD_DEVIATION 12.1 |
| BMI | 29.3 kg/m^2 STANDARD_DEVIATION 6 | 29.2 kg/m^2 STANDARD_DEVIATION 6 | 28.8 kg/m^2 STANDARD_DEVIATION 5.5 | 35.9 kg/m^2 STANDARD_DEVIATION 13.9 | 29.3 kg/m^2 STANDARD_DEVIATION 6.3 |
| Region of Enrollment United States United States | 89 Participants | 88 Participants | 48 Participants | 6 Participants | 231 Participants |
| Sex/Gender, Customized Female | 43 Participants | 49 Participants | 29 Participants | 5 Participants | 126 Participants |
| Sex/Gender, Customized Male | 45 Participants | 38 Participants | 19 Participants | 1 Participants | 103 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 | 8 / 89 | 13 / 88 | 5 / 48 | 2 / 6 |
| serious Total, serious adverse events | 3 / 89 | 1 / 88 | 0 / 48 | 0 / 6 |
Outcome results
Primary
Radiographic Fusion
Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels
Time frame: 24 Months
Population: Number of subjects present for the 24 month visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1-level | Radiographic Fusion | 66 percentage of subjects |
| 2-level | Radiographic Fusion | 46 percentage of subjects |
| 3-level | Radiographic Fusion | 37 percentage of subjects |
| 4-level | Radiographic Fusion | 75 percentage of subjects |
Primary
Radiographic Fusion
Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels
Time frame: 12 Months
Population: Number of subjects present for the 12 month visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1-level | Radiographic Fusion | 48 percentage of subjects |
| 2-level | Radiographic Fusion | 25 percentage of subjects |
| 3-level | Radiographic Fusion | 27 percentage of subjects |
| 4-level | Radiographic Fusion | 20 percentage of subjects |
Secondary
Neck Disability Index (NDI) is a Widely Used Instrument for Assessing Self-reported Disability in Patients With Neck Pain. Scoring is Reported on a 0-100 Point Scale, 0 Being the Best Possible Score and 100 Being the Worst Possible Score
Average NDI score at 24 months - score range is 0 to 100, with 0 being the best and 100 being the worst
Time frame: 24 Months
Population: The Total Population enrolled and treated includes 89 (1-Level), 88 (2-Level), 48 (3-Level), and 6 (4-Level). With each outcome measure, the actual Overall Number of Participants Analyzed will vary based on the actual number of participants who completed the specific assessment at the specific timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-level | Neck Disability Index (NDI) is a Widely Used Instrument for Assessing Self-reported Disability in Patients With Neck Pain. Scoring is Reported on a 0-100 Point Scale, 0 Being the Best Possible Score and 100 Being the Worst Possible Score | 27 units on a scale | Standard Deviation 22 |
| 2-level | Neck Disability Index (NDI) is a Widely Used Instrument for Assessing Self-reported Disability in Patients With Neck Pain. Scoring is Reported on a 0-100 Point Scale, 0 Being the Best Possible Score and 100 Being the Worst Possible Score | 29 units on a scale | Standard Deviation 21 |
| 3-level | Neck Disability Index (NDI) is a Widely Used Instrument for Assessing Self-reported Disability in Patients With Neck Pain. Scoring is Reported on a 0-100 Point Scale, 0 Being the Best Possible Score and 100 Being the Worst Possible Score | 24 units on a scale | Standard Deviation 22 |
| 4-level | Neck Disability Index (NDI) is a Widely Used Instrument for Assessing Self-reported Disability in Patients With Neck Pain. Scoring is Reported on a 0-100 Point Scale, 0 Being the Best Possible Score and 100 Being the Worst Possible Score | 17 units on a scale | Standard Deviation 16 |