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

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ClinicalTrials.gov Identifier: NCT02318433
Recruitment Status : Active, not recruiting
First Posted : December 17, 2014
Last Update Posted : March 25, 2019
Sponsor:
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.

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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
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02318433


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Sanjeev Kakar, M.D., M.B.A Mayo Clinic

Additional Information:
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Responsible Party: Sanjeev (Sanj) Kakar, M.D., M.B.A., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02318433     History of Changes
Other Study ID Numbers: 14-004033
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sanjeev (Sanj) Kakar, M.D., M.B.A., Mayo Clinic:
DRF
PTOA
dexamethasone
Additional relevant MeSH terms:
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Osteoarthritis
Radius Fractures
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Forearm Injuries
Arm Injuries
Wounds and Injuries
Fractures, Bone
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action