Investigation of Corticosteroid Versus Placebo Injection in Patients With Syndesmotic Ligament Injury or High Ankle Sprain

• Status: Terminated
• Trial end date: 2016-09-21
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the use of corticosteroids acutely as an adjuvant treatment of the high ankle sprain. Subjects will receive either a corticosteroid or a local anesthetic injection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanford Health
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Bupivacaine

Criteria

Inclusion Criteria:

• Age 16 years or older

• Musculoskeletal ultrasound performed which demonstrates injury pattern consistent with high ankle sprain.

• Must sign the informed consent form and agree to meet the needs of the study

• Clinically and ultra sound confirmed and isolated syndesmotic ligament injury or high ankle sprain without associated fracture

• Injury occurred within the previous 7 days

Exclusion Criteria:

• Surgical intervention required to stabilize the ankle

• Unable to read and understand the consent form

• Unable to meet the needs of the follow-up examinations

• Allergic to the betamethasone

• Current fungal infection

• Pregnancy or currently breast feeding