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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02318433

Collaborator

(none)

Enrollment

Location

Arms

55.6

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

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 :

Dec 1, 2014

Actual Primary Completion Date :

Jul 19, 2019

Actual Study Completion Date :

Jul 19, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

PTOA incidence [3 years]
Primary outcome measure will incidence of post-traumatic osteoarthritis, determined by joint space narrowing, as measured radiologically.

Secondary Outcome Measures

Functional assessment [3 years]
A composite of clinical measurements of grip strength and pinch strength.
Patient-rated evaluations [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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