Intra-Articular Dexamethasone to Prevent Post-Traumatic Osteoarthritis: A Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intra-Articular Dexamethasone to Prevent Post-Traumatic Osteoarthritis: A Pilot Study

Conditions
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Distal Radius Fracture, Osteoarthritis

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unstable distal radius fracture Fracture type AO B1, B2, B3, C1, C2 or C3. 18-65 years old Understand and read English Community dwelling (not in assisted living or NH) Exclusion criteria: Open or bilateral DRF Associated upper extremity carpal fracture or carpal ligament injuries requiring casting or surgical repair at the time of DRF fixation. Greater than 2 weeks post injury Neurologic disorders affecting the hand, wrist or arm. History of permanent dementia, Alzheimer's or other neurologic dx Substance abuse Pathologic fractures Known pregnancy Radiocarpal joint arthritis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>Subjects receive dexamethasone (4 mg) injection within the radiocarpal joint either in clinic or in the OR. | Drug: Dexamethasone<br>* Data demonstrates that low doses of dexamethasone preserves chondrocyte viability, protects collagen, and maintains proteoglycan synthesis in cartilage subjected to injurious compression.<br>|
| Placebo Comparator: Saline<br>Subjects receive sterile saline (4 mg) injection within the radiocarpal joint either in clinic or in the OR. | Drug: Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTOA incidence | Primary outcome measure will incidence of post-traumatic osteoarthritis, determined by joint space narrowing, as measured radiologically. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional assessment | A composite of clinical measurements of grip strength and pinch strength. | 3 years | 
| Patient-rated evaluations | 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). | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DRF, PTOA, dexamethasone