ACDF Using Structural Allograft vs. Tritanium C
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Degenerative Disc Disease
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Other
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
Retrospective subjects will consist of 20 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. These subjects will be retrospectively reviewed for radiographic outcomes at 3, 6 and ...
Retrospective subjects will consist of 20 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. These subjects will be retrospectively reviewed for radiographic outcomes at 3, 6 and 12 months postoperatively, as well as adverse events and sensory and motor outcomes. If available, NDI and VAS questionnaires completed during baseline and post-op visits will be collected. Prospective subjects will consist of 20 patients who are receiving Tritanium C as standard of care. These subjects will be asked to complete NDI and VAS questionnaires at baseline and post-op visits. Radiographic outcomes, adverse events, sensory and motor neurological outcomes, as determined per standard of care will be collected at those same time points. The total number of subjects is N=40.
Tracking Information
- NCT #
- NCT04388332
- Collaborators
- Stryker Spine
- Investigators
- Principal Investigator: Nestor Tomycz, MD Allegheny Health Network
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