Prospective, Single Center, Open Label Clinical Study. The purpose of the study is to collect safety data associated with the use of the OsteoProbe System. Study Duration is expected to take approximately 3 months from first subject enrolled to the last follow-up visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
40
The OsteoProbe® System ("OsteoProbe") is a bone microindentation measurement tool. The device is a measurement tool that is not intended to make a diagnosis or provide a treatment decision. There are no other available measurement tools for clinical assessment of bone's resistance to microindentation.
Meridian Clinical Research, LLC.
Omaha, Nebraska, United States
The Number of Participants With Reported Device Related Serious Adverse Events.
The number of participants who experienced device-related serious adverse events (SAEs) in subjects evaluated with the OsteoProbe System, per potential risks in the protocol.
Time frame: Procedure
The Number of Participants With Reported Device Related Serious Adverse Events.
The incidence of device-related serious adverse events (SAEs) in subjects evaluated with the OsteoProbe System.
Time frame: 1-day follow up visit
The Number of Participants With Reported Device Related Serious Adverse Events.
The incidence of device-related serious adverse events (SAEs) in subjects evaluated with the OsteoProbe System.
Time frame: 7-day follow up visit
The Number of Participants With Reported Device Related Serious Adverse Events.
The number of participants who experienced device-related serious adverse events (SAEs) in subjects evaluated with the OsteoProbe System, per potential risks in the protocol.
Time frame: 30-day follow up visit
NRS Pain Scores
The Numeric Rating Scale (NRS) is a continuous scale comprised of a line, with an eleven point numeric range (0 to 10) anchored by 2 verbal descriptors, one for each symptom extreme. The 0 mark corresponds to 'no pain', while the 10 mark corresponds to 'worse pain possible'. Therefore, higher scores indicate greater pain intensity. At all follow-up time points (post-procedure, Day 1, Day 7 , and Day 30), average was taken compared to baseline (Pre-Procedure).
Time frame: Post-procedure, 1-day, 7-day and 30-day follow up visits
BMSi Scores
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
BSMi Score is an output measure by the OsteoProbe device to measure bone tissue's resistance to microindentation which can be positively correlated with bone tissue quality.
Time frame: Procedure
Number of Participants With Adverse Events
The number of participants who experienced an adverse event.
Time frame: Procedure through day 30
Number of Participants With Device-related Adverse Events
The number of participants who experienced an device-related adverse event.
Time frame: Procedure through day 30
Number of Participants With Serious Adverse Events
The number of participants who experienced a Serious adverse event.
Time frame: Procedure through day 30
Unanticipated Adverse Device Effects (UADE)
The number of participants who experienced a Unanticipated adverse device effects.
Time frame: Procedure through day 30