Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02318433
Recruitment Status : Completed
First Posted : December 17, 2014
Last Update Posted : April 13, 2020
Information provided by (Responsible Party):
Sanjeev (Sanj) Kakar, M.D., M.B.A., Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Distal Radius Fracture Osteoarthritis Drug: Dexamethasone Drug: Saline Early Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Intra-Articular Dexamethasone to Prevent Post-Traumatic Osteoarthritis: A Pilot Study
Study Start Date : December 2014
Actual Primary Completion Date : July 19, 2019
Actual Study Completion Date : July 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Dexamethasone
Subjects receive dexamethasone (4 mg) injection within the radiocarpal joint either in clinic or in the OR.
Drug: Dexamethasone
Data demonstrates that low doses of dexamethasone preserves chondrocyte viability, protects collagen, and maintains proteoglycan synthesis in cartilage subjected to injurious compression.

Placebo Comparator: Saline
Subjects receive sterile saline (4 mg) injection within the radiocarpal joint either in clinic or in the OR.
Drug: Saline

Primary Outcome Measures :
  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 Outcome Measures :
  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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02318433

Layout table for location information
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Layout table for investigator information
Principal Investigator: Sanjeev Kakar, M.D., M.B.A Mayo Clinic
Additional Information:
Layout table for additonal information
Responsible Party: Sanjeev (Sanj) Kakar, M.D., M.B.A., PI, Mayo Clinic Identifier: NCT02318433    
Other Study ID Numbers: 14-004033
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sanjeev (Sanj) Kakar, M.D., M.B.A., Mayo Clinic:
Additional relevant MeSH terms:
Layout table for MeSH terms
Radius Fractures
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Forearm Injuries
Arm Injuries
Wounds and Injuries
Fractures, Bone
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents