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Completed

NCT Number: NCT02318433

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

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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Key information

Conditions

Distal Radius Fracture Arm Injuries Arthritis Fractures, Bone Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

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

Saline

Drug

Primary outcomes

  1. PTOA incidence

    Time frame: 3 years

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

Secondary outcomes

  1. Functional assessment

    Time frame: 3 years

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

  2. Patient-rated evaluations

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Dec 17, 2014
Registry last updated
Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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