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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2019-07-19

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.

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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.

Conditions

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Distal Radius Fracture Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dexamethasone

Subjects receive dexamethasone (4 mg) injection within the radiocarpal joint either in clinic or in the OR.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

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

Saline

Subjects receive sterile saline (4 mg) injection within the radiocarpal joint either in clinic or in the OR.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Interventions

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Dexamethasone

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

Intervention Type DRUG

Saline

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No