The goal of this study is to determine whether two new, non-X-ray techniques can discriminate between high-energy fractures of normal bone (trauma) and low-energy fractures (fragility) of osteoporotic bone. The current gold-standard for assessing fracture risk areal bone mineral density (aBMD) by dual energy X-ray absorptiometry (DXA) is not particularly effective at identifying individuals who are at risk of suffering a fracture. Yet, there is a growing population of diabetics and elderly individuals prone to fractures. In effect, the age-related and diabetes-related increase in fracture risk is independent of a person's aBMD. These findings stress the urgency in developing diagnostic tools that can improve fracture risk prediction so that patients can be treated with the appropriate anti-fracture therapies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
48
Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).
Assessment of Fracture Risk
Determines bound water and pore water of bone.
Vanderbilt Univeristy Medical Center
Nashville, Tennessee, United States
Osteoprobe Measurements
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.
Time frame: Within a week before or after surgery to repair distal radius fracture
MRI Scan Measurements
Bound Water Fraction
Time frame: Within a week before or after surgery to repair distal radius fracture
MRI Scan Measurements
Pore Water Fraction
Time frame: Within a week before or after surgery to repair distal radius fracture
DXA Scan Measurements
Bone Mineral Density
Time frame: Within a week before or after surgery to repair distal radius fracture
DXA Scan Measurements
Bone Mineral Content
Time frame: Within a week before or after surgery to repair distal radius fracture
DXA Scan Measurements
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.
Time frame: Within a week before or after surgery to repair distal radius fracture
Patient-reported Measurements
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.
Time frame: Baseline/One-Time Completion and Post-op/-treatment: 3, 6, and 12 weeks
Patient-reported Measurements
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.
Time frame: Baseline and Post-op/-treatment: 3, 6, and 12 weeks
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