Open Label Study Using OsteoProbe System

Inclusion criteria

• Be greater than or equal to 22 years of age;
• Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
• If female and of child-bearing potential, must have a negative pregnancy status.

Exclusion criteria

• Active skin infection at the procedure site as identified during a SOC physical examination.
• Subject-reported or known systemic infection;
• Subject-reported or known allergy to local anesthetic;
• Subject-reported or known allergy to stainless steel or nickel materials;
• Subject-reported or known current use of systemic antibiotics, or topical antibiotics administered to the procedure site;
• Subject-reported or known history of needle phobia;
• Significant soft tissue at the procedure site which would preclude use of the OsteoProbe in the judgement of the Investigator;
• Known instance of hardware in the tibia that is intended to be measured based on radiographic imaging;
• Known instance of a previous or current fracture in the tibia that is intended to be measured based on radiographic imaging;
• Are known to be actively participating or known to have participated in another clinical investigation for which they received an investigational product (including but not limited to a drug or vaccine) within the last 90 days, or reports that they intend to participate in another clinical investigation during the course of the study;
• Are known to be currently abusing drugs or alcohol or have a known history of the same within the last 12 months;
• Have any known or subject reported mental or psychological disorders that, in the judgement of the Investigator, would impair their ability to accurately complete the NRS Pain Score surveys;
• Are currently a prisoner;
• Have a condition which, in the judgement of the Investigator, would preclude adequate evaluation of the device's safety and performance. Conditions include but are not limited to:

• Regional or systemic pain syndromes
• Radicular pain syndromes
• Chronic or intermittent leg pain
• Migraine headaches