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

Early Phase 1CompletedNCT02318433

Mayo Clinic43 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Distal Radius Fracture Osteoarthritis

Interventions

DexamethasoneDRUG

Data demonstrates that low doses of dexamethasone preserves chondrocyte viability, protects collagen, and maintains proteoglycan synthesis in cartilage subjected to injurious compression.

SalineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

PTOA incidence

Primary outcome measure will incidence of post-traumatic osteoarthritis, determined by joint space narrowing, as measured radiologically.

Time frame: 3 years

Secondary Outcomes

Functional assessment

A composite of clinical measurements of grip strength and pinch strength.

Time frame: 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).

Time frame: 3 years

Data from ClinicalTrials.gov

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