Back to resultsIntra-Articular Dexamethasone to Prevent Post-Traumatic Osteoarthritis: A Pilot Study
Primary Purpose
Distal Radius Fracture, Osteoarthritis
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Saline
Sponsored by
About this trial
This is an interventional prevention trial for Distal Radius Fracture focused on measuring DRF, PTOA, dexamethasone
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexamethasone
Saline
Arm Description
Subjects receive dexamethasone (4 mg) injection within the radiocarpal joint either in clinic or in the OR.
Subjects receive sterile saline (4 mg) injection within the radiocarpal joint either in clinic or in the OR.
Outcomes
Primary Outcome Measures
PTOA incidence
Primary outcome measure will incidence of post-traumatic osteoarthritis, determined by joint space narrowing, as measured radiologically.
Secondary Outcome Measures
Functional assessment
A composite of clinical measurements of grip strength and pinch strength.
Patient-rated evaluations
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02318433
Brief Title
Intra-Articular Dexamethasone to Prevent Post-Traumatic Osteoarthritis: A Pilot Study
Official Title
Intra-Articular Dexamethasone to Prevent Post-Traumatic Osteoarthritis: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
July 19, 2019 (Actual)
Study Completion Date
July 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture, Osteoarthritis
Keywords
DRF, PTOA, dexamethasone
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Subjects receive dexamethasone (4 mg) injection within the radiocarpal joint either in clinic or in the OR.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Subjects receive sterile saline (4 mg) injection within the radiocarpal joint either in clinic or in the OR.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
PTOA incidence
Description
Primary outcome measure will incidence of post-traumatic osteoarthritis, determined by joint space narrowing, as measured radiologically.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Functional assessment
Description
A composite of clinical measurements of grip strength and pinch strength.
Time Frame
3 years
Title
Patient-rated evaluations
Description
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).
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjeev Kakar, M.D., M.B.A
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Intra-Articular Dexamethasone to Prevent Post-Traumatic Osteoarthritis: A Pilot Study
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