Trial Outcomes & Findings for New Tools for Assessing Fracture Risk (NCT NCT02436356)
NCT ID: NCT02436356
Last Updated: 2020-11-02
Results Overview
Bone Material Strength index (BMSi) By engaging the bone at 10 N and then delivering a single impact force of \~40 N, the OsteoProbe records the maximum penetration depth of conical-spherical tip into cortical bone. This indentation distance increase (IDI) is indexed to the IDI acquired from a reference material immediately after the bone IDI measurements, such that the OsteoProbe-based measurement known as bone material strength index (BMSi) is 100 times IDI of reference material divided by IDI of the patient's bone. A lower BMSi measurement is the result of a higher indentation distance into the bone. For statistical analysis, we used the mean of the 10 BMSi measurements per case.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
Within a week before or after surgery to repair distal radius fracture
Results posted on
2020-11-02
Participant Flow
Participant milestones
| Measure |
Distal Radius Fracture Operative Group
Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.
Osteoprobe-RPI (Reference Point Indentation): Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Healthy Volunteers (Non Fracture Group)
Healthy volunteers will undergo DXA and MRI scans.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Distal Radius Fracture Non-operative Group
Fracture group patients will undergo DXA and MRI scans, but will not undergo Osteoprobe indentation.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
11
|
4
|
|
Overall Study
High Energy Fracture
|
14
|
0
|
4
|
|
Overall Study
Low Energy Fracture
|
19
|
0
|
0
|
|
Overall Study
COMPLETED
|
28
|
10
|
2
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
2
|
Reasons for withdrawal
| Measure |
Distal Radius Fracture Operative Group
Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.
Osteoprobe-RPI (Reference Point Indentation): Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Healthy Volunteers (Non Fracture Group)
Healthy volunteers will undergo DXA and MRI scans.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Distal Radius Fracture Non-operative Group
Fracture group patients will undergo DXA and MRI scans, but will not undergo Osteoprobe indentation.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
|---|---|---|---|
|
Overall Study
Excluded by MRI Screening
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Surgical Approach (Dorsal not volar)
|
1
|
0
|
0
|
|
Overall Study
Excluded due to other medical conditions
|
3
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
BMI unavailable for one subject in distal radius fracture operative group.
Baseline characteristics by cohort
| Measure |
Distal Radius Fracture Operative Group
n=28 Participants
Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.
Osteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Healthy Volunteers (Non Fracture Group)
n=10 Participants
Healthy volunteers will undergo DXA and MRI scans.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Distal Radius Fracture Non-operative Group
n=2 Participants
Fracture group patients will undergo DXA and MRI scans, but will not undergo Osteoprobe indentation.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47 years
n=28 Participants
|
44 years
n=10 Participants
|
30 years
n=2 Participants
|
40 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=28 Participants
|
7 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
26 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=28 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=2 Participants
|
14 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=28 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=28 Participants
|
9 Participants
n=10 Participants
|
2 Participants
n=2 Participants
|
37 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=28 Participants
|
10 Participants
n=10 Participants
|
2 Participants
n=2 Participants
|
37 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=28 Participants
|
10 participants
n=10 Participants
|
2 participants
n=2 Participants
|
40 participants
n=40 Participants
|
|
Body Mass Index (BMI)
|
27.9 kg/m2
n=27 Participants • BMI unavailable for one subject in distal radius fracture operative group.
|
27.55 kg/m2
n=10 Participants • BMI unavailable for one subject in distal radius fracture operative group.
|
25.61 kg/m2
n=2 Participants • BMI unavailable for one subject in distal radius fracture operative group.
|
27.7 kg/m2
n=39 Participants • BMI unavailable for one subject in distal radius fracture operative group.
|
PRIMARY outcome
Timeframe: Within a week before or after surgery to repair distal radius fracturePopulation: Only Distal Radius Fracture Operative Group subjects underwent Osteoprobe measurements where Bone Material Strength index (BMSi) was obtained.
Bone Material Strength index (BMSi) By engaging the bone at 10 N and then delivering a single impact force of \~40 N, the OsteoProbe records the maximum penetration depth of conical-spherical tip into cortical bone. This indentation distance increase (IDI) is indexed to the IDI acquired from a reference material immediately after the bone IDI measurements, such that the OsteoProbe-based measurement known as bone material strength index (BMSi) is 100 times IDI of reference material divided by IDI of the patient's bone. A lower BMSi measurement is the result of a higher indentation distance into the bone. For statistical analysis, we used the mean of the 10 BMSi measurements per case.
Outcome measures
| Measure |
Distal Radius Fracture Operative Group
n=28 Participants
Distal Radius Fracture Operative group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.
Osteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Healthy Volunteers
Healthy volunteers will undergo DXA and MRI scans.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Distal Radius Fracture Non-Operative Group
Distal Radius Fracture Non-Operative group patients will undergo DXA and MRI scans.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
|---|---|---|---|
|
Osteoprobe Measurements
High Energy
|
73.3 Index
Interval 60.2 to 79.8
|
—
|
—
|
|
Osteoprobe Measurements
Low Energy
|
76.3 Index
Interval 70.1 to 79.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Within a week before or after surgery to repair distal radius fracturePopulation: Distal Radius Fracture Nonoperative Group- 2 subjects did not have MRI scan data. Healthy Volunteers- 1 subject did not take part in the MRI scan. Distal Radius Fracture Operative Group- 8 Low Energy and 6 high energy subjects did not take part in the MRI scan. 3 high energy subjects did not have usable MRI data due to technical issues.
Bound Water Fraction
Outcome measures
| Measure |
Distal Radius Fracture Operative Group
n=14 Participants
Distal Radius Fracture Operative group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.
Osteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Healthy Volunteers
n=10 Participants
Healthy volunteers will undergo DXA and MRI scans.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Distal Radius Fracture Non-Operative Group
Distal Radius Fracture Non-Operative group patients will undergo DXA and MRI scans.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
|---|---|---|---|
|
MRI Scan Measurements
High Energy Fracture
|
12.6 percentage of bound water fraction
Interval 9.51 to 33.0
|
—
|
—
|
|
MRI Scan Measurements
Low Energy Fracture
|
16.6 percentage of bound water fraction
Interval 12.8 to 20.0
|
—
|
—
|
|
MRI Scan Measurements
No fracture
|
—
|
25.9 percentage of bound water fraction
Interval 21.1 to 30.2
|
—
|
PRIMARY outcome
Timeframe: Within a week before or after surgery to repair distal radius fracturePopulation: Distal Radius Fracture Nonoperative Group- 2 subjects did not have MRI scan data. Healthy Volunteers- 1 subject did not take part in the MRI scan. Distal Radius Fracture Operative Group- 8 Low Energy and 6 high energy subjects did not take part in the MRI scan. 3 high energy subjects did not have usable MRI data due to technical issues.
Pore Water Fraction
Outcome measures
| Measure |
Distal Radius Fracture Operative Group
n=14 Participants
Distal Radius Fracture Operative group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.
Osteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Healthy Volunteers
n=10 Participants
Healthy volunteers will undergo DXA and MRI scans.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Distal Radius Fracture Non-Operative Group
Distal Radius Fracture Non-Operative group patients will undergo DXA and MRI scans.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
|---|---|---|---|
|
MRI Scan Measurements
High Energy Fracture
|
12.9 percentage of pore water fraction
Interval 1.86 to 17.1
|
—
|
—
|
|
MRI Scan Measurements
Low Energy Fracture
|
17.4 percentage of pore water fraction
Interval 8.5 to 22.7
|
—
|
—
|
|
MRI Scan Measurements
No fracture
|
—
|
10.4 percentage of pore water fraction
Interval 7.7 to 12.1
|
—
|
PRIMARY outcome
Timeframe: Within a week before or after surgery to repair distal radius fracturePopulation: Distal Radius Fracture Operative Group- Includes 9 high energy fracture and 14 low energy fracture subjects. High Energy: 1 did not have L1-L4 scanned, 2 did not receive calculations due to age. Low Energy- 3 did not have a DXA scan. Healthy Volunteers- 1 subject did not have a DXA scan.
Bone Mineral Density
Outcome measures
| Measure |
Distal Radius Fracture Operative Group
n=23 Participants
Distal Radius Fracture Operative group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.
Osteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Healthy Volunteers
n=10 Participants
Healthy volunteers will undergo DXA and MRI scans.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Distal Radius Fracture Non-Operative Group
n=2 Participants
Distal Radius Fracture Non-Operative group patients will undergo DXA and MRI scans.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
|---|---|---|---|
|
DXA Scan Measurements
High Energy- L1 -L4 VB
|
1.119 g/cm^2
Interval 1.022 to 1.546
|
—
|
1.475 g/cm^2
Interval 1.022 to 1.475
|
|
DXA Scan Measurements
Low Energy- L1-L4 VB
|
1.165 g/cm^2
Interval 1.058 to 1.322
|
—
|
—
|
|
DXA Scan Measurements
No Fracture- L1-L4 VB
|
—
|
1.138 g/cm^2
Interval 0.908 to 1.302
|
—
|
|
DXA Scan Measurements
High Energy- Hip
|
1.088 g/cm^2
Interval 0.949 to 1.213
|
—
|
1.197 g/cm^2
Interval 0.902 to 1.197
|
|
DXA Scan Measurements
Low Energy- Hip
|
0.909 g/cm^2
Interval 0.798 to 1.024
|
—
|
—
|
|
DXA Scan Measurements
No Fracture- Hip
|
—
|
0.988 g/cm^2
Interval 0.777 to 1.14
|
—
|
|
DXA Scan Measurements
High Energy- Femur neck
|
1.063 g/cm^2
Interval 0.876 to 1.167
|
—
|
1.322 g/cm^2
Interval 0.849 to 1.322
|
|
DXA Scan Measurements
Low Energy- Femur neck
|
0.920 g/cm^2
Interval 0.825 to 1.039
|
—
|
—
|
|
DXA Scan Measurements
No fracture- Femur neck
|
—
|
1.008 g/cm^2
Interval 0.753 to 1.135
|
—
|
|
DXA Scan Measurements
High Energy- Radius distal-third
|
0.938 g/cm^2
Interval 0.754 to 1.041
|
—
|
1.059 g/cm^2
Interval 0.851 to 1.059
|
|
DXA Scan Measurements
Low Energy- Radius distal-third
|
0.833 g/cm^2
Interval 0.695 to 0.958
|
—
|
—
|
|
DXA Scan Measurements
No Fracture- Radius distal-third
|
—
|
0.887 g/cm^2
Interval 0.683 to 1.069
|
—
|
|
DXA Scan Measurements
High Energy- Radius ultra-distal
|
0.924 g/cm^2
Interval 0.743 to 1.128
|
—
|
1.071 g/cm^2
Interval 0.837 to 1.071
|
|
DXA Scan Measurements
Low Energy- Radius ultra-distal
|
0.810 g/cm^2
Interval 0.647 to 0.908
|
—
|
—
|
|
DXA Scan Measurements
No Fracture- Radius ultra-distal
|
—
|
0.883 g/cm^2
Interval 0.761 to 1.043
|
—
|
PRIMARY outcome
Timeframe: Within a week before or after surgery to repair distal radius fracturePopulation: Distal Radius Fracture Operative Group- Includes 9 high energy fracture and 14 low energy fracture subjects. High Energy: 1 did not have L1-L4 scanned, 2 did not receive calculations due to age. Low Energy- 3 did not have a DXA scan. Healthy Volunteers- 1 subject did not have a DXA scan.
Bone Mineral Content
Outcome measures
| Measure |
Distal Radius Fracture Operative Group
n=23 Participants
Distal Radius Fracture Operative group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.
Osteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Healthy Volunteers
n=10 Participants
Healthy volunteers will undergo DXA and MRI scans.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Distal Radius Fracture Non-Operative Group
n=2 Participants
Distal Radius Fracture Non-Operative group patients will undergo DXA and MRI scans.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
|---|---|---|---|
|
DXA Scan Measurements
High Energy L1-L4 VB
|
65.04 g
Interval 50.54 to 101.7
|
—
|
98.87 g
Interval 58.63 to 98.87
|
|
DXA Scan Measurements
No Fracture- Radius distal-third
|
—
|
2.43 g
Interval 1.84 to 2.57
|
—
|
|
DXA Scan Measurements
Low Energy L1-L4 VB
|
74.24 g
Interval 53.21 to 74.61
|
—
|
—
|
|
DXA Scan Measurements
No Fracture L1-L4 VB
|
—
|
70.19 g
Interval 47.86 to 74.91
|
—
|
|
DXA Scan Measurements
High Energy- Hip
|
43.03 g
Interval 29.37 to 47.17
|
—
|
44.97 g
Interval 31.56 to 44.97
|
|
DXA Scan Measurements
Low Energy- Hip
|
33.5 g
Interval 25.6 to 35.88
|
—
|
—
|
|
DXA Scan Measurements
No Fracture- Hip
|
—
|
36.97 g
Interval 22.43 to 38.38
|
—
|
|
DXA Scan Measurements
High Energy- Femur neck
|
6.05 g
Interval 4.32 to 6.3
|
—
|
7.26 g
Interval 4.58 to 7.26
|
|
DXA Scan Measurements
Low Energy- Femur neck
|
4.848 g
Interval 3.99 to 5.05
|
—
|
—
|
|
DXA Scan Measurements
No Fracture- Femur neck
|
—
|
5.49 g
Interval 3.73 to 6.11
|
—
|
|
DXA Scan Measurements
High Energy- Radius distal-third
|
3.07 g
Interval 1.76 to 3.38
|
—
|
3.64 g
Interval 2.09 to 3.64
|
|
DXA Scan Measurements
Low Energy- Radius distal-third
|
2.433 g
Interval 1.7 to 2.59
|
—
|
—
|
|
DXA Scan Measurements
High Energy- Radius ultra-distal
|
2.39 g
Interval 1.35 to 2.67
|
—
|
2.43 g
Interval 1.64 to 2.43
|
|
DXA Scan Measurements
Low Energy- Radius ultra-distal
|
1.713 g
Interval 1.03 to 1.96
|
—
|
—
|
|
DXA Scan Measurements
No Fracture- Radius ultra-distal
|
—
|
1.87 g
Interval 1.23 to 2.04
|
—
|
PRIMARY outcome
Timeframe: Within a week before or after surgery to repair distal radius fracturePopulation: Distal Radius Fracture Operative Group- Includes 7 high energy fracture and 14 low energy fracture subjects. High Energy: 1 did not have L1-L4 scanned, 2 did not receive calculations due to age. Low Energy- 3 did not have a DXA scan. Healthy Volunteers- 1 subject did not have a DXA scan.
A T-score is the number of standard deviations (SD) below (negative value) or above (positive value) the mean BMD (bone mineral density) for a healthy population. A person with T-score below -2.5 is considered to have osteoporosis.
Outcome measures
| Measure |
Distal Radius Fracture Operative Group
n=21 Participants
Distal Radius Fracture Operative group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.
Osteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Healthy Volunteers
n=10 Participants
Healthy volunteers will undergo DXA and MRI scans.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Distal Radius Fracture Non-Operative Group
n=2 Participants
Distal Radius Fracture Non-Operative group patients will undergo DXA and MRI scans.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
|---|---|---|---|
|
DXA Scan Measurements
High Energy- L1-L4 VB
|
0.8 t-score
Interval -1.3 to 2.5
|
—
|
1.9 t-score
Interval -1.7 to 1.9
|
|
DXA Scan Measurements
Low Energy- L1-L4 VB
|
0.6 t-score
Interval -1.5 to 0.7
|
—
|
—
|
|
DXA Scan Measurements
No Fracture- L1-L4 VB
|
—
|
0.5 t-score
Interval -2.3 to 0.6
|
—
|
|
DXA Scan Measurements
High Energy- Hip
|
1.2 t-score
Interval -1.7 to 1.6
|
—
|
0.8 t-score
Interval -1.4 to 0.8
|
|
DXA Scan Measurements
Low Energy- Hip
|
-0.2 t-score
Interval -1.7 to -0.1
|
—
|
—
|
|
DXA Scan Measurements
No Fracture- Hip
|
—
|
0.7 t-score
Interval -1.8 to 0.8
|
—
|
|
DXA Scan Measurements
High Energy- Femur neck
|
0.7 t-score
Interval -1.3 to 1.4
|
—
|
1.9 t-score
Interval -1.7 to 1.9
|
|
DXA Scan Measurements
Low Energy- Femur neck
|
-0.4 t-score
Interval -1.5 to -0.2
|
—
|
—
|
|
DXA Scan Measurements
No Fracture- Femur neck
|
—
|
0.3 t-score
Interval -2.1 to 0.5
|
—
|
|
DXA Scan Measurements
High Energy- Radius distal-third
|
0.7 t-score
Interval -2.2 to 0.7
|
—
|
0.7 t-score
Interval -1.4 to 0.7
|
|
DXA Scan Measurements
Low Energy- Radius distal-third
|
0.8 t-score
Interval -2.1 to 0.9
|
—
|
—
|
|
DXA Scan Measurements
No Fracture- Radius distal-third
|
—
|
0.6 t-score
Interval -2.2 to 0.8
|
—
|
|
DXA Scan Measurements
High Energy- Radius ultra-distal
|
1.3 t-score
Interval -4.0 to 3.9
|
—
|
1.3 t-score
Interval -2.3 to 1.3
|
|
DXA Scan Measurements
Low Energy- Radius ultra-distal
|
-1.0 t-score
Interval -4.2 to -0.2
|
—
|
—
|
|
DXA Scan Measurements
No Fracture- Radius ultra-distal
|
—
|
0.2 t-score
Interval -0.8 to 0.4
|
—
|
SECONDARY outcome
Timeframe: Baseline/One-Time Completion and Post-op/-treatment: 3, 6, and 12 weeksPopulation: Distal Radius Fracture Operative Group- Includes 11 high energy fracture and 17 low energy fracture subjects. Healthy Volunteers were only asked to complete the DASH at the baseline visit.
DASH (Disabilities of the Arm, Shoulder, and Hand) is a 30-item self-report questionnaire designed to assess musculoskeletal disorders of the upper limbs. The score ranges from 0 (no disability) to 100 (most severe disability). A higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability.
Outcome measures
| Measure |
Distal Radius Fracture Operative Group
n=28 Participants
Distal Radius Fracture Operative group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.
Osteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Healthy Volunteers
n=10 Participants
Healthy volunteers will undergo DXA and MRI scans.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Distal Radius Fracture Non-Operative Group
n=2 Participants
Distal Radius Fracture Non-Operative group patients will undergo DXA and MRI scans.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
|---|---|---|---|
|
Patient-reported Measurements
Low Energy- 12 Week
|
21.92 score on a scale
Standard Deviation 20.67
|
—
|
—
|
|
Patient-reported Measurements
High Energy- Baseline
|
41.18 score on a scale
Standard Deviation 28.08
|
—
|
27.66 score on a scale
Standard Deviation 6.83
|
|
Patient-reported Measurements
Low Energy- Baseline
|
59.89 score on a scale
Standard Deviation 18.50
|
—
|
—
|
|
Patient-reported Measurements
No Fracture- Baseline
|
—
|
0.83 score on a scale
Standard Deviation 1.04
|
—
|
|
Patient-reported Measurements
High Energy- 3 Week
|
35.39 score on a scale
Standard Deviation 25.13
|
—
|
7.50 score on a scale
Standard Deviation 6.66
|
|
Patient-reported Measurements
Low Energy- 3 Week
|
50.73 score on a scale
Standard Deviation 18.85
|
—
|
—
|
|
Patient-reported Measurements
High Energy- 6 Week
|
28.43 score on a scale
Standard Deviation 24.46
|
—
|
38.93 score on a scale
Standard Deviation 20.98
|
|
Patient-reported Measurements
Low Energy- 6 Week
|
38.93 score on a scale
Standard Deviation 20.98
|
—
|
—
|
|
Patient-reported Measurements
High Energy- 12 Week
|
3.33 score on a scale
Standard Deviation 4.45
|
—
|
0.84 score on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: Baseline and Post-op/-treatment: 3, 6, and 12 weeksPopulation: Only subjects with a fracture were asked to complete the PRWE survey. Distal Radius Fracture Operative Group- Includes 11 high energy fracture and 17 low energy fracture subjects.
PRWE (Patient-rated wrist evaluation) is a 15-item survey designed to measure wrist pain and disability in activities of daily living. The PRWE consists of a pain subscale and a function subscale. The pain subscale contains 5 items, each rated 0 (no pain) to 10 (worst pain ever). The pain subscale is calculated by adding all 5 item scores together (minimum score: 0, maximum score: 50). A lower score indicates a lower pain level. The function subscale contains 10 items, each rated 0 (no difficulty) to 10 (unable to do). The function subscale is calculated by adding all 10 item scores together and dividing by 2 (minimum score: 0, maximum score: 100). A lower score indicates a lower disability level. The total PRWE score is calculated by adding the pain and function subscales together. The total PRWE score ranges from 0 (best score) to 100 (worst score). The lower the score the better the outcome.
Outcome measures
| Measure |
Distal Radius Fracture Operative Group
n=28 Participants
Distal Radius Fracture Operative group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.
Osteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Healthy Volunteers
Healthy volunteers will undergo DXA and MRI scans.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
Distal Radius Fracture Non-Operative Group
n=2 Participants
Distal Radius Fracture Non-Operative group patients will undergo DXA and MRI scans.
Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk
MRI: Determines bound water and pore water of bone.
|
|---|---|---|---|
|
Patient-reported Measurements
Low Energy- 12 Week
|
28.23 score on a scale
Standard Deviation 25.99
|
—
|
—
|
|
Patient-reported Measurements
High Energy- Baseline
|
70.45 score on a scale
Standard Deviation 18.89
|
—
|
43.5 score on a scale
Standard Deviation 4.5
|
|
Patient-reported Measurements
Low Energy- Baseline
|
76.30 score on a scale
Standard Deviation 16.85
|
—
|
—
|
|
Patient-reported Measurements
High Energy- 3 Week
|
52.44 score on a scale
Standard Deviation 27.04
|
—
|
13.5 score on a scale
Standard Deviation 7.5
|
|
Patient-reported Measurements
Low Energy- 3 Week
|
61.11 score on a scale
Standard Deviation 15.29
|
—
|
—
|
|
Patient-reported Measurements
High Energy- 6 Week
|
39.53 score on a scale
Standard Deviation 24.89
|
—
|
10 score on a scale
Standard Deviation 6
|
|
Patient-reported Measurements
Low Energy- 6 Week
|
47.69 score on a scale
Standard Deviation 25.43
|
—
|
—
|
|
Patient-reported Measurements
High Energy-12 Week
|
5.29 score on a scale
Standard Deviation 5.37
|
—
|
2 score on a scale
Standard Deviation 2
|
Adverse Events
Distal Radius Fracture Operative Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Volunteers (Non Fracture Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Distal Radius Fracture Non-operative Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jeffry S. Nyman, Ph.D.
Vanderbilt University Medical Center
Phone: 615-936-6296
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has 30 days prior to proposed submission date/release of publication to review results, provide comments. Within 30 days of receipt of proposed publication, Sponsor shall advise PI in writing if information contains Sponsor's confidential information (CI) or patentable matter. In addition, upon written request by Sponsor, PI shall delay submission of such publication for an additional 60 days in order to allow Active Life to apply for patent or other protection for Sponsor inventions.
- Publication restrictions are in place
Restriction type: OTHER