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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-level | Patients needing a single level cervical fusion with Vectra-T |
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| 2-level | Patients needing cervical fusion at two consecutive levels with Vectra-T |
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| 3-level | Patients needing cervical fusion at three consecutive levels with Vectra-T |
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| 4-level | Patients needing cervical fusion at four consecutive levels with Vectra-T |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vectra-T | Device | Patient will receive the Vectra-T plate (Sized 1 to 4 levels) |
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| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Fusion | Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels | 24 Months |
| Radiographic Fusion | Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 Months |
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Inclusion Criteria:
One to four levels (consecutive) cervical degenerative disc disease between C2 and C7, defined as at least one of the following:
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:
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Surgeon's personal patient contacts
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| Name | Affiliation | Role |
|---|---|---|
| Donald Kovalsky, M.D. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roderick Sanden, MD | Carmichael | California | 95608 | United States | ||
| Yu-Po Lee, MD |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| La Jolla |
| California |
| 92093-0706 |
| United States |
| Ardavan Aslie, MD | Marysville | California | 95901 | United States |
| Barry Chehrazi, MD | Roseville | California | 95661 | United States |
| Don Kovalsky, MD | Mount Vernon | Illinois | 62864 | United States |
| Mark Crawford, MD | Fort Wayne | Indiana | 46804 | United States |
| Faheem Sandhu, MD | Clinton | Maryland | 20735 | United States |
| Chris Urban, MD | Glen Burnie | Maryland | 21061 | United States |
| John Moriarity, MD | Flowood | Mississippi | 39232 | United States |
| Jamal Taha, MD | Kettering | Ohio | 45429 | United States |
| Abhay Varma, MD | Charleston | South Carolina | 29425 | United States |
| Daniel Nehls, MD | Tacoma | Washington | 98405 | United States |
| Dennis Maiman, MD | Milwaukee | Wisconsin | 53226 | United States |
| FG002 | 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) |
| FG003 | 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) |
| Evaluated at 12 Months |
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| COMPLETED |
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| NOT COMPLETED |
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Subjects Enrolled and Treated Per Protocol
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | 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) |
| BG002 | 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) |
| BG003 | 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) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age and Gender was not available for two (2) subjects. These subjects were treated at 1 and 2 Levels respectively. | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Gender was not reported for 2 Subjects; 1 at Level 1 and 1 at Level 2. Number analyzed will differ from other reported populations | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| BMI | BMI unit of measure is kg/m^2 | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Radiographic Fusion | Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels | Number of subjects present for the 24 month visit | Posted | Number | percentage of subjects | 24 Months |
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| Primary | Radiographic Fusion | Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels | Number of subjects present for the 12 month visit | Posted | Number | percentage of subjects | 12 Months |
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| 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 | 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. | Posted | Mean | Standard Deviation | units on a scale | 24 Months |
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From enrollment through 24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) | 3 | 89 | 8 | 89 | ||
| EG001 | 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) | 1 | 88 | 13 | 88 | ||
| EG002 | 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) | 0 | 48 | 5 | 48 | ||
| EG003 | 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) | 0 | 6 | 2 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Union | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dysphagia | Nervous system disorders | Systematic Assessment |
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| Hematoma | Blood and lymphatic system disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma / Seroma | Blood and lymphatic system disorders | Systematic Assessment |
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| Neurological Deficit | Psychiatric disorders | Systematic Assessment |
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| Dysphagia | Nervous system disorders | Systematic Assessment |
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| Non-Union | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Stroke | Vascular disorders | Systematic Assessment |
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| Seizure | Nervous system disorders | Systematic Assessment |
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| Numbness or Tingling | Nervous system disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Lotito | DePuy Synthes Spine | 508-880-8045 | mlotito@its.jnj.com |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| OG003 | 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) |
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