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.
Drug: bupivacaine hydrochloride and betamethasone sodium phosphate
Drug: bupivacaine hydrochloride
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Full eligibility criteria for NCT02892500
Ages eligible for Study
16 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT02892500
United States (1)
Sanford Orthopedics and Sports Medicine
Fargo, North Dakota, United States, 58103
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View full eligibility
Tris trial is registered with FDA with number: NCT02892500. The sponsor of the trial is Sanford Health and it is looking for 58 volunteers for the current phase.
Official trial title: Single-site, Double Blinded, Randomized Investigation of Corticosteroid Versus Placebo Injection Under Ultrasound Guidance in Patients With Syndesmotic Ligament Injury or High Ankle Sprain
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