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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02318433
• Other study ID #: 14-004033
• Status: Completed
• Phase: Early Phase 1
• Start date: December 2014
• Est. completion date: July 19, 2019

Study information

• Verified date: March 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 19, 2019
• Est. primary completion date: July 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Osteoarthritis
• Radius Fractures

Intervention

Drug:
• Dexamethasone
Data demonstrates that low doses of dexamethasone preserves chondrocyte viability, protects collagen, and maintains proteoglycan synthesis in cartilage subjected to injurious compression.
• Saline

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTOA incidence	Primary outcome measure will incidence of post-traumatic osteoarthritis, determined by joint space narrowing, as measured radiologically.	3 years
Secondary	Functional assessment	A composite of clinical measurements of grip strength and pinch strength.	3 years
Secondary	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).	3 years

External Links

•   Mayo Clinic Clinical Trials