Adverse Effects in the Use of the OsteoProbe System
Conditions
Brief summary
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.
Interventions
DEVICEOsteoProbe System
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.
Sponsors
MCRA
Active Life Scientific, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With Reported Device Related Serious Adverse Events. | Procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMSi Scores | Procedure | 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. |
| Number of Participants With Adverse Events | Procedure through day 30 | The number of participants who experienced an adverse event. |
| NRS Pain Scores | Post-procedure, 1-day, 7-day and 30-day follow up visits | 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). |
| Number of Participants With Serious Adverse Events | Procedure through day 30 | The number of participants who experienced a Serious adverse event. |
| Unanticipated Adverse Device Effects (UADE) | Procedure through day 30 | The number of participants who experienced a Unanticipated adverse device effects. |
| Number of Participants With Device-related Adverse Events | Procedure through day 30 | The number of participants who experienced an device-related adverse event. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OsteoProbe System OsteoProbe System: 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. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | OsteoProbe System | — |
|---|---|---|
| Age, Continuous | 45.95 years STANDARD_DEVIATION 14.41 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 40 participants | — |
| Sex: Female, Male Female | 30 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 1 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OsteoProbe System | The Number of Participants With Reported Device Related Serious Adverse Events. | 0 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OsteoProbe System | The Number of Participants With Reported Device Related Serious Adverse Events. | 0 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OsteoProbe System | The Number of Participants With Reported Device Related Serious Adverse Events. | 0 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OsteoProbe System | The Number of Participants With Reported Device Related Serious Adverse Events. | 0 Participants |
Secondary
BMSi Scores
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsteoProbe System | BMSi Scores | 77.35 score | Standard Deviation 8.24 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OsteoProbe System | NRS Pain Scores | 0 score on a scale | Standard Deviation 0 |
Secondary
Number of Participants With Adverse Events
The number of participants who experienced an adverse event.
Time frame: Procedure through day 30
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OsteoProbe System | Number of Participants With Adverse Events | 1 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OsteoProbe System | Number of Participants With Device-related Adverse Events | 1 Participants |
Secondary
Number of Participants With Serious Adverse Events
The number of participants who experienced a Serious adverse event.
Time frame: Procedure through day 30
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OsteoProbe System | Number of Participants With Serious Adverse Events | 0 Participants |
Secondary
Unanticipated Adverse Device Effects (UADE)
The number of participants who experienced a Unanticipated adverse device effects.
Time frame: Procedure through day 30
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OsteoProbe System | Unanticipated Adverse Device Effects (UADE) | 0 Participants |