Distal Radius Fracture, Osteoarthritis
Conditions
Keywords
DRF, PTOA, dexamethasone
Brief summary
The primary aim of the study is to see if a single wrist injection (intra-articular) of dexamethasone at the time of treatment will reduce the incidence of early-onset of post traumatic osteoarthritis.
Detailed description
Our hypothesis is that the intra-articular administration of dexamethasone soon after joint injury will prevent the subsequent development of PTOA, and restore normal joint homeostasis. We plan to generate the data needed to test this hypothesis in a Phase 0 (pilot) clinical trial using patients who have suffered distal radius fractures.
Interventions
DRUGDexamethasone
Data demonstrates that low doses of dexamethasone preserves chondrocyte viability, protects collagen, and maintains proteoglycan synthesis in cartilage subjected to injurious compression.
DRUGSaline
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Unstable distal radius fracture 2. Fracture type AO B1, B2, B3, C1, C2 or C3. 3. 18-65 years old 4. Understand and read English 5. Community dwelling (not in assisted living or NH)
Exclusion criteria
1. Open or bilateral DRF 2. Associated upper extremity carpal fracture or carpal ligament injuries requiring casting or surgical repair at the time of DRF fixation. 3. Greater than 2 weeks post injury 4. Neurologic disorders affecting the hand, wrist or arm. 5. History of permanent dementia, Alzheimer's or other neurologic dx 6. Substance abuse 7. Pathologic fractures 8. Known pregnancy 9. Radiocarpal joint arthritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTOA incidence | 3 years | Primary outcome measure will incidence of post-traumatic osteoarthritis, determined by joint space narrowing, as measured radiologically. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional assessment | 3 years | A composite of clinical measurements of grip strength and pinch strength. |
| Patient-rated evaluations | 3 years | Composite scores from patient-rated evaluations including the Disabilities of the Arm Shoulder and Hand (DASH), the Michigan Hand Questionnaire (MHQ), and the Patient-Rated Wrist Evaluation (PRWE). |
Countries
United States
Outcome results
None listed