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

Mayo Clinic

Status and phase: Completed; Early Phase 1

Conditions: Osteoarthritis; Distal Radius Fracture

Treatments: Drug: Saline; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02318433

14-004033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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43 participants in 2 patient groups, including a placebo group

Dexamethasone

Experimental group

Description:

Subjects receive dexamethasone (4 mg) injection within the radiocarpal joint either in clinic or in the OR.

Treatment:

Drug: Dexamethasone

Saline

Placebo Comparator group

Description:

Subjects receive sterile saline (4 mg) injection within the radiocarpal joint either in clinic or in the OR.

Treatment:

Drug: Saline