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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.
 
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

Tracking Information
First Submitted Date  ICMJE December 8, 2014
First Posted Date  ICMJE December 17, 2014
Last Update Posted Date March 25, 2019
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
PTOA incidence [ Time Frame: 3 years ]
Primary outcome measure will incidence of post-traumatic osteoarthritis, determined by joint space narrowing, as measured radiologically.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02318433 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
  • Functional assessment [ Time Frame: 3 years ]
    A composite of clinical measurements of grip strength and pinch strength.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intra-Articular Dexamethasone to Prevent Post-Traumatic Osteoarthritis: A Pilot Study
Official Title  ICMJE Intra-Articular Dexamethasone to Prevent Post-Traumatic Osteoarthritis: A Pilot Study
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Distal Radius Fracture
  • Osteoarthritis
Intervention  ICMJE
  • Drug: Dexamethasone
    Data demonstrates that low doses of dexamethasone preserves chondrocyte viability, protects collagen, and maintains proteoglycan synthesis in cartilage subjected to injurious compression.
  • Drug: Saline
Study Arms  ICMJE
  • Experimental: Dexamethasone
    Subjects receive dexamethasone (4 mg) injection within the radiocarpal joint either in clinic or in the OR.
    Intervention: Drug: Dexamethasone
  • Placebo Comparator: Saline
    Subjects receive sterile saline (4 mg) injection within the radiocarpal joint either in clinic or in the OR.
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 21, 2019)
43
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2014)
40
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02318433
Other Study ID Numbers  ICMJE 14-004033
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sanjeev (Sanj) Kakar, M.D., M.B.A., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sanjeev Kakar, M.D., M.B.A Mayo Clinic
PRS Account Mayo Clinic
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP