Open Label Study Using OsteoProbe System (OP)

Active Life Scientific

Status: Completed

Conditions: Adverse Effects in the Use of the OsteoProbe System

Treatments: Device: OsteoProbe System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04628221

OP2020

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Active skin infection at the procedure site as identified during a SOC physical examination.

2. Subject-reported or known systemic infection;

3. Subject-reported or known allergy to local anesthetic;

4. Subject-reported or known allergy to stainless steel or nickel materials;

5. Subject-reported or known current use of systemic antibiotics, or topical antibiotics administered to the procedure site;

6. Subject-reported or known history of needle phobia;

7. Significant soft tissue at the procedure site which would preclude use of the OsteoProbe in the judgement of the Investigator;

8. Known instance of hardware in the tibia that is intended to be measured based on radiographic imaging;

9. Known instance of a previous or current fracture in the tibia that is intended to be measured based on radiographic imaging;

10. 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;

11. Are known to be currently abusing drugs or alcohol or have a known history of the same within the last 12 months;

12. 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;

13. Are currently a prisoner;

14. 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:

    1. Regional or systemic pain syndromes
    2. Radicular pain syndromes
    3. Chronic or intermittent leg pain
    4. Migraine headaches

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)