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
|Condition or disease||Intervention/treatment||Phase|
|Distal Radius Fracture Osteoarthritis||Drug: Dexamethasone Drug: Saline||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Subjects receive dexamethasone (4 mg) injection within the radiocarpal joint either in clinic or in the OR.
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.
- PTOA incidence [ Time Frame: 3 years ]Primary outcome measure will incidence of post-traumatic osteoarthritis, determined by joint space narrowing, as measured radiologically.
- 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).
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
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Sanjeev Kakar, M.D., M.B.A||Mayo Clinic|