Study Results
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View full resultsBasic Information
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TERMINATED
NA
48 participants
INTERVENTIONAL
2015-06-30
2018-11-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Distal Radius Fracture Operative Group
Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.
Osteoprobe-Reference Point Indentation (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)
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.
Interventions
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Osteoprobe-Reference Point Indentation (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.
Eligibility Criteria
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Inclusion Criteria
2. Patients who have sustained a low or high energy distal radius fracture that involves the metaphysis and requires open reduction internal fixation using volar plating.
3. English speaking due to feasibility of employing study personnel to deliver and assess study intervention.
1. Patients who are 18 years of age or older.
2. Patients who have no history of fracture or family history of pathologic fracture
3. English speaking due to feasibility of employing study personnel to deliver and assess study intervention.
1. Patients who are 18 years of age or older. This age range accounts for 60% of all distal radius fractures seen at Vanderbilt University Medical Center.
2. Patients who have sustained a low or high energy distal radius fracture that requires nonoperative treatment
3. English speaking due to feasibility of employing study personnel to deliver and assess study intervention.
Exclusion Criteria
1. Patients who have known risk factors of pathologic fractures (e.g. bone metastasis)
2. Patients who have or are receiving treatment for osteoporosis (e.g. bisphosphonate) lasted longer than 5 years
3. Patients who have Type 1 diabetes
4. Patients who have other bone disease (e.g., osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism)
5. Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use
6. Patients that would not be able to have a DXA scan (weight \>350lbs, hardware in hips, patients that have lap band device)
7. Patients who are pregnant or who think they may be pregnant
8. Patients that have a medical contraindication to MRI (if patients are undergoing a study MRI)
9. Patients who have concurrent, bilateral upper extremity fractures where hardware or casting may affect study scan measurements
10. Patients who have distal radial shaft fractures
Number of patients in Arm#2= 40 patients
1. Patients who are taking medication to treat osteoporosis (e.g. bisphosphonate)
2. Patients who have or are receiving treatment for osteoporosis (e.g. bisphosphonate) lasted longer than 5 years
3. Patients who have Type 1 diabetes
4. Patients who have other bone disease (e.g., osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism).
5. Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use.
6. Patients that would not be able to have a DXA scan (weight \>350lbs, hardware in hips, patients that have lap band device)
7. Patients who are pregnant or who think they may be pregnant.
8. Patients that have a medical contraindication to MRI.
Number of patients in Arm#3= up to 10 patients
1. Patients who have known risk factors of pathologic fractures (e.g. bone metastasis)
2. Patients who have or are receiving treatment for osteoporosis (e.g. bisphosphonate) lasted longer than 5 years
3. Patients who have Type 1 diabetes
4. Patients who have other bone disease (e.g., osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism)
5. Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use
6. Patients that would not be able to have a DXA scan (weight \>350lbs, hardware in hips, patients that have lap band device)
7. Patients who are pregnant or who think they may be pregnant
8. Patients that have a medical contraindication to MRI (if patients are undergoing a study MRI)
9. Patients who have concurrent, bilateral upper extremity fractures where hardware or casting may affect study scan measurements
18 Years
ALL
Yes
Sponsors
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ActiveLife Scientific
INDUSTRY
National Center for Advancing Translational Sciences (NCATS)
NIH
Vanderbilt University Medical Center
OTHER
Responsible Party
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Jeffry Nyman
Assistant Professor of Orthopaedics and Rehabilitation
Principal Investigators
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Jeffry S Nyman, PhD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt Univeristy Medical Center
Nashville, Tennessee, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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141125
Identifier Type: -
Identifier Source: org_study_id