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The purpose of this combined retrospective and prospective clinical study is to examine the clinical outcomes of the ROI-C® anterior cervical interbody fusion device with VerteBRIDGE® plating to treat single level degenerative disc disease between C2 and T1 in the short term, with a focus on fusion rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operated Subjects | ROIC interbody cage with VerteBRIDGE plating |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROIC interbody cage with VerteBRIDGE plating | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Fusion | Rate of fusion using A/P, lateral, and flexion/extension radiographs at each time point; defined by the presence of bridging bone with less than 2° segmental motion in flexion/extension and less than 3mm of A/P translation. | 12 months or more after device implantation; mean follow up 20.7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain | NDI is a standard instrument for measuring self-rated disability due to neck pain. It is scored from 0-50, with results multiplied by 2 to arrive at a percentage. Lowest scores represent no disability, high scores represent worse disability. A VAS is a measurement instrument for pain that measures the degree across a continuum or straight line. The endpoints define extreme limits, from 0-10, with 0 representing no pain and 10 severe pain. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be drawn from community surgeon practices in which the subjects have already received the device and who meet the Inclusion/Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Robert J Jackson, MD | Orange County Neurosurgical Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Neurological Associates | Laguna Hills | California | United States | |||
| Orthpedic Specialists of Northwest Indiana |
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| ID | Title | Description |
|---|---|---|
| FG000 | Operated Subjects With ROI-C Device | Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 12 months (Last available visit) post surgery |
| Munster |
| Indiana |
| United States |
| Greater Baltimore Medical Center | Baltimore | Maryland | United States |
| Baystate Medical Center | Springfield | Massachusetts | United States |
| New England Orthopedic Surgeons | Springfield | Massachusetts | United States |
| St Francis Hospital | Greenville | South Carolina | United States |
| Franciscan Neurosurgery Associates | Tacoma | Washington | United States |
| COMPLETED |
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| NOT COMPLETED |
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Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Operated Subjects With ROI-C Device | Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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 | Percentage of Participants With Fusion | Rate of fusion using A/P, lateral, and flexion/extension radiographs at each time point; defined by the presence of bridging bone with less than 2° segmental motion in flexion/extension and less than 3mm of A/P translation. | Posted | Number | Percentage of Participants | 12 months or more after device implantation; mean follow up 20.7 months |
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| Secondary | Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain | NDI is a standard instrument for measuring self-rated disability due to neck pain. It is scored from 0-50, with results multiplied by 2 to arrive at a percentage. Lowest scores represent no disability, high scores represent worse disability. A VAS is a measurement instrument for pain that measures the degree across a continuum or straight line. The endpoints define extreme limits, from 0-10, with 0 representing no pain and 10 severe pain. | Operated Subjects | Posted | Mean | Full Range | Units on a Scale | 12 months (Last available visit) post surgery |
|
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Date of surgery through last follow up visit, mean of 20.7 months
Any change from baseline in a subject's condition during the clinical study. This includes events that are related to the device as well as events that are not related to the device.
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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 | Operated Subjects With ROI-C Device | Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit. | 0 | 110 | 2 | 110 | 42 | 110 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pseudoarthrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Cervical stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper extremity pain/numbness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Fall/Injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Lower back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Shoulder injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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This was a single-arm study that enrolled participants retrospectively. An active control is not available for comparison of results and changes from baseline are not available.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs | Zimmer Biomet | 303-501-8571 | tammy.stinson2@zimmerbiomet.com |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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