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Clinical Studies
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Closed for Enrollment
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Arthrex Primary Total Knee and Unicondylar Knee Registry
Rochester, Minn.
The objective of the study is a multi-center prospective registry to collect clinical outcomes of knee arthroplasty.
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Examining the Objective Diagnosis of Concussions (ODC) in Junior A Hockey Players Related to Concussion History, Player Position, Mechanisms of Injury and Individual Exposure Time (IET)
Rochester, Minn.
Concussion is a health issue impacting all athletes for which a clinical treatment protocol, other than rest, has not been established. The efficacy of such a treatment protocol relies heavily on an objective diagnosis and quantification of injury severity. We hypothesize our chosen objective diagnostic and injury quantification measures will show significant differences between non-concussed and concussed athletes to aid in future treatment protocols. We also hypothesize that data from individual exposure time, video footage, and personality measures will provide additional information to further characterize concussive injuries and support diagnostic and treatment protocols.
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Objective Concussion Diagnosis and Quantification of Severity: A Process Essential to the Brain Health of Hockey Players and to the “Ice to Axon” Research
Rochester, Minn.
Treating athletes for concussion requires rigorous epidemiology, objective diagnoses, a clinical treatment protocol, and informed prevention. Specifically, to test the quantified electroencephalography measured by NeuroCatch, a novel blood biomarker (SNTF), and metabolomics profiling. Such data will greatly advance evidence-based interventions, appropriate concussion management and permit USA Hockey to accurately measure the effects of our safety programs. This study is not being conducted to support an FDA submission.
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Objective Concussion Diagnosis and Quantification of Severity: A Process Essential to the Brain Health of Hockey Players and to the “Ice to Axon” Research, Year 2
Rochester, Minn.
Diagnostic and injury quantification measures will show significant differences between non-concussed and concussed athletes to aid in future treatment protocols. Data from accelerometers and video footage will provide additional information to further characterize concussive injuries and support diagnostic and treatment protocols.
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Preparing to Treat Concussions in Adolescent Hockey and Football Players Using the From Ice and Field to the Axon and Astrocyte Model
Rochester, Minn.
The purpose of this study is to further demonstrate the value of the components of our objective diagnosis and quantification of severity: the NeuroCatch quantified electroencephalogram, the King-Devick test, blood biomarkers, and metabolomics profiling. Wearable accelerometers (Triax SIM-G) and video footage will provide data to correlate concussive injuries with physical parameters and mechanisms of injury. Time on Ice tracking will allow for calculation of Individual Exposure Time (IET).
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Preparing to Treat Concussions in Hockey Players Using a From Ice to Axon and Astrocyte Repeated Measures Design
Rochester, Minn.
The purpose of this study is to demonstrate the value of our objective diagnosis of concussion (ODC) components and to quantify severity. ODC components include: the NeuroCatch™ Platform [quantified electroencephalogram (qEEG)] developed by NeuroCatch Inc., the King-Devick Test (in association with Mayo Clinic) of rapid number naming, and blood biomarkers such as neurofilament light (NfL), neuron-specific enolase (NSE), and S100B. Wearable accelerometers (Triax Technologies’ SIM-G, X2 Biosystems X Patch, and Prevent Biometrics’ Impact Monitor Mouthguard) and three camera video footage will also provide acceleration data to correlate to concussive injuries and mechanism of injury. Time on Ice tracking will allow for calculation of Individual Exposure Time (IET).
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