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Poor enrollment
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The purpose of this prospective clinical study is to examine the short-term safety and efficacy of the Avenue®- L interbody Spinal Fusion System with VerteBRIDGE® plating to treat one and two level degenerative disc disease between L2 and S1 with a focus on fusion rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operated Subjects | Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avenue® L Interbody Fusion System (LDR Spine) | Device | PEEK, intervertebral cage for interbody fusion of the lumbar spine |
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| Measure | Description | Time Frame |
|---|---|---|
| Fusion Rate | Number of participants with fused disc space as measured radiographically | 12 months after device implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Oswestry Disability Index (ODI) | The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be drawn from the patient populations of the physicians participating in the study. The principal investigators include community physicians in private practice as well as physicians affiliated with academic institutions.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Spine and Orthopedics | Thornton | Colorado | United States | |||
| Orthopedic Surgery |
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| ID | Title | Description |
|---|---|---|
| FG000 | Operated Subjects | Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1 Avenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| preop, 3 mo, 6 mo, 12 mo post op |
| Visual Analog Scale (VAS) of Back Pain | The pain VAS is a continuous scale comprised of a horizontal line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme of either "no pain" or "worst imaginable pain". The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. | preop, 3 mo, 6 mo, 12 mo |
| Atlanta |
| Georgia |
| United States |
| Jersey Shore University Medical Center | Neptune City | New Jersey | United States |
| Southern New York Neurosurgical Group | Johnson City | New York | United States |
| COMPLETED |
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| NOT COMPLETED |
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Subjects enrolled and completed surgery with implant of Avenue L device
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| ID | Title | Description |
|---|---|---|
| BG000 | Operated Subjects | Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1 Avenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine |
| 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 | Mean | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI (kg/m^2) | Mean | Full Range | kg/m^2 |
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| Previous Lumbar Surgery | Count of Participants | Participants |
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| Surgical Level | Count of Participants | 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 | Fusion Rate | Number of participants with fused disc space as measured radiographically | Poor enrollment led to early termination and low number of participants available for analysis. Data were available for 13 participants preoperatively, 12 at 3 months, 8 at 6 months, and 6 at 12 months. Only 3 of 6 participants reaching 12 month follow up had radiographs available for analysis. | Posted | Count of Participants | Participants | 12 months after device implantation |
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| Secondary | Mean Oswestry Disability Index (ODI) | The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible. | Data were available for 13 participants preoperatively, 12 at 3 months, 8 at 6 months, and 6 at 12 months | Posted | Mean | Full Range | score on a scale | preop, 3 mo, 6 mo, 12 mo post op |
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| Secondary | Visual Analog Scale (VAS) of Back Pain | The pain VAS is a continuous scale comprised of a horizontal line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme of either "no pain" or "worst imaginable pain". The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. | Data were available for 13 participants preoperatively, 12 at 3 months, 8 at 6 months, and 6 at 12 months | Posted | Mean | Full Range | units on a scale | preop, 3 mo, 6 mo, 12 mo |
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From time of surgery through 12 months post op
All events deemed adverse in nature were reported. When available, a diagnosis was recorded versus a symptom. Events were assessed for relatedness to the device and include a brief description of treatment and outcome (ongoing or resolved)
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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 | Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1 Avenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine | 0 | 13 | 0 | 13 | 6 | 13 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Hernia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Ischemia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Seroma | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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Poor enrollment led to early termination and low number of participants available for analysis
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs | Zimmer Biomet Spine | 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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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| L4-L5 |
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| L2-L4 |
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