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

NCT02318433 | Completed Early Phase 1

• 1 other identifier: 14-004033
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fracture; Osteoarthritis

Keywords

DRF; PTOA; dexamethasone

Outcome Measures

Primary Outcomes (1)

• PTOA incidence

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

  3 years

Secondary Outcomes (2)

• Functional assessment

  3 years

• Patient-rated evaluations

  3 years

Study Arms (2)

Dexamethasone

EXPERIMENTAL

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

Drug: Dexamethasone

Saline

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Dexamethasone DRUG

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

Dexamethasone

Saline DRUG

Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unstable distal radius fracture
• Fracture type AO B1, B2, B3, C1, C2 or C3.
• years old
• Understand and read English
• Community dwelling (not in assisted living or NH)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Wrist Fractures; Osteoarthritis

Interventions

Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Sanjeev Kakar, M.D., M.B.A

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 17, 2014
• Study Start: December 1, 2014
• Primary Completion: July 19, 2019
• Study Completion: July 19, 2019
• Last Updated: April 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)