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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 80 Years|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Nestor Tomycz, MD|
|Principal Investigator Affiliation||Allegheny Health Network|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Degenerative Disc Disease|
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.
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.
20 patients who are receiving Tritanium C as standard of care.
Procedure: - Structural allograft
Subjects that have received ACDF structural allograft with plates with autograft and/or allograft comprised of cancellous and/or corticocancellous bone chips
Device: - Tritanium C
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
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Laurie M Dennis, RN, BS