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| Name | Class |
|---|---|
| VB Spine, LLC | INDUSTRY |
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This is an observational, descriptive, prospective and retrospective data collection study. The purpose of this study is to observe radiographic outcomes of patients who will undergo anterior cervical discectomy and fusion (ACDF) utilizing Tritanium C (Stryker Spine). The rate of fusion success and adverse events will be compared retrospectively to patients who underwent instrumented ACDF utilizing structural allograft bone with plates.
Retrospective Cohort: A maximum of 200 patients that received one or two level ACDF structural allograft with plates with autograft and/or allograft comprised of cancellous and/or corticocancellous bone chips at AHN in the past will retrospectively be screened for inclusion into a pool of potential candidates for the retrospective cohort. Patients will be included in this preliminary pool if the following information are available: age (at surgery), sex, body mass index (at surgery), no smoking at baseline, number of levels operated on, which specific levels were operated on, standard of care clinic follow-up at 6 and 12 months (3 month visit not required) and imaging that can be used to assess fusion at baseline, 6 and 12 months (3 month imaging not required). If available, NDI and VAS, questionnaires completed during baseline and post-op visits will be collected.
This pool of retrospective cohort candidates will be used to match the patients in the prospective cohort to patients treated with structural allograft using a 1:2 ratio. Thus, 40 patients will ultimately be included in the retrospective cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective | Active Comparator | 40 patients that received one or two level ACDF structural allograft with plates with autograft and /or allograft comprised of cancellous and/or corticocancellous bone chips. |
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| Prospective | Experimental | 20 patients who are receiving Tritanium C as standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structural allograft | Procedure | Subjects that have received ACDF structural allograft with plates with autograft and/or allograft comprised of cancellous and/or corticocancellous bone chips |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the presence of fusion | Antero-posterior and lateral plain radiographs | 3 months post-operatively |
| Time to the presence of fusion | Antero-posterior and lateral plain radiographs | 6 months post-operatively |
| Time to the presence of fusion | Antero-posterior and lateral plain radiographs | 12 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Neck disability | Neck Disability Index (NDI): Subjects will designate a statement that best describes their level of disability for each section of the survey. Statements are then ranked from 0-5, where 0 is a better outcome and 5 is a worse outcome. All rankings are totaled for a final score. | Baseline, 3, 6, and 12 months post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
Patients may not be enrolled in the study if any of the following exclusion criteria are present:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nestor Tomycz, MD | Contact | 412-359-6200 | nestor.tomycz@ahn.org | |
| Alexander Yu, MD | Contact | 412-359-6200 | alexander.yu@ahn.org |
| Name | Affiliation | Role |
|---|---|---|
| Nestor Tomycz, MD | Allegheny Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allegheny Health Network | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
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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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retrospective/prospective observational, two arm study - 40 patients in retrospective cohort (data collection from previous procedure) compared to 20 patients in Prospective cohort
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| Tritanium C | Device | Subjects will receive the Tritanium C anterior cervical cage which is intended to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft |
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| Neck and arm pain |
Visual Analog Scale (VAS) for neck and arm pain: Subjects will designate a score to represent their pain from 0 to 10. 0 is indicative of no pain and 10 is indicative of the worst possible pain. |
| Baseline, 3, 6, and 12 months post-operatively |
| Incidence of sensory deficits | Yes or no response to: Sensory deficit at the surgical level, sensory deficit at an adjacent level to the surgical level, sensory deficit at a different level to the surgical level, any sensory deficit during follow-up | Baseline, 3, 6, and 12 months post-operatively |
| Incidence of motor deficits | Yes or no response to: Motor deficit at the surgical level, motor deficit at an adjacent level to the surgical level, motor deficit at a different level to the surgical level, any motor deficit | Baseline, 3, 6, and 12 months post-operatively |
| Rate of Adverse Events | Adverse Event assessment | Day of surgery, 3, 6 and 12 month post-operatively |