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The purpose of this combination retrospective and prospective post market study is to examine the short term safety and efficacy of the ROI-A® interbody fusion device with VerteBRIDGE® plates to treat single and two-level degenerative disc disease between L2 and S1, with a focus on fusion rates and patient outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operated Subjects | ROIA Interbody Cage with VerteBRIDGE plating |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROIA Interbody Cage with VerteBRIDGE plating | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Fusion | Fusion was assessed utilizing both AP and flexion/extension radiographs. Fusion was noted when all three of the criteria were present: 1) presence of bridging bone as identified by radiography, 2)Less than 5 degrees of segmental motion on flexion/extension radiographs, and 3) Less than 3 mm of A/P translation on flexion/extension radiographs | 12 months after device implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Oswestry Disability Index | The Oswestry Disability Index (ODI) is and index to quantify disability for low back pain. There are 50 possible points which are multiplied by 2 to arrive at a percentage score. Zero is equated with no disability and 100 is the maximum disability possible | 12 months after device implantation |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Operated Subjects | ROIA Interbody Cage with VerteBRIDGE plating |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Operated Subjects | ROIA Interbody Cage with VerteBRIDGE plating |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Fusion | Fusion was assessed utilizing both AP and flexion/extension radiographs. Fusion was noted when all three of the criteria were present: 1) presence of bridging bone as identified by radiography, 2)Less than 5 degrees of segmental motion on flexion/extension radiographs, and 3) Less than 3 mm of A/P translation on flexion/extension radiographs | Posted | Count of Participants | Participants | 12 months after device implantation |
|
|
From enrollment through final follow up (12 month) visit
An adverse event is defined as 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 | ROIA Interbody Cage with VerteBRIDGE plating | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower extremity neuropathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs | Zimmer Biomet Spine | 303-501-8571 | tammy.stinson2@zimmerbiomet.com |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI (kg/mg^2) | Mean | Standard Deviation | kg/mg^2 |
|
| Current smoker | Count of Participants | Participants |
|
| Previous Lumbar Spine Surgery | Count of Participants | Participants |
|
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| Secondary | Mean Oswestry Disability Index | The Oswestry Disability Index (ODI) is and index to quantify disability for low back pain. There are 50 possible points which are multiplied by 2 to arrive at a percentage score. Zero is equated with no disability and 100 is the maximum disability possible | Posted | Mean | Standard Deviation | score on a scale | 12 months after device implantation |
|
|
|
| 51 |
| 0 |
| 51 |
| 5 |
| 51 |
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
| Lower back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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