Clinical Trial: Investigation of Corticosteroid Versus Placebo Injection in Patients With Syndesmotic Ligament Injury or High Ankle Sprain
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official 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
Brief 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.
Detailed Summary: The term "high ankle sprain" refers to injury to the syndesmotic ligaments of the ankle. It has become a much more common injury comprising up to 24.6% of all ankle sprains , with an incidence of 2.4 per 1000 athlete exposures. These can present a significant therapeutic challenge for the sports physician and typically result in a prolonged morbidity and delayed return to activity. The literature shows a lack of information for definitive care of these athletes. Typical recovery for the high ankle sprain is almost twice as long as the more common lateral ankle inversion sprain with a mean time to return to play of 45 days. There is also a higher incidence of residual chronic pain comparing high ankle sprains to an isolated lateral ankle sprain. The current standard for treatment of this injury has been to depend on symptomatic treatment with an initial phase of rest and protected splinting. This is followed by the use of NSAID's with a graduated rehabilitation program to reduce swelling, improve range of motion, and regain strength and proprioception of the ankle. This is followed by protective taping or bracing and return to activities as tolerated. Inflammation is one of the body's first reactions to injury. Release of damaged cells and tissue debris occurs upon injury. These expelled particles act as antigens to stimulate a nonspecific immune response and to cause the proliferation of leukocytes. Local blood flow increases to transport the polymorphonuclear leukocytes, macrophages, and plasma proteins to the injured area. A redistribution of arteriolar flow produces stasis and hypoxia at the injury site. The resulting infiltration of tissues by the leukocytes, plasma proteins, and fluid causes the redness, swelling, and pain that are characteristic of inflammation. Initially, the inflammatory reaction serves several important purposes. The influx of leukocytes facilitates the process of phagocytosis and the removal of damaged cells and other particulate
Sponsor: Sanford Health
Current Primary Outcome: Compare between the two groups the time to return to previous levels of activity [ Time Frame: One year ]
Original Primary Outcome: Compare between the two groups the time to return to previous levels of activity [ Time Frame: Evaluated weekly through one year ]
Current Secondary Outcome: Compare patient reported outcomes between the two groups using the Foot and Ankle Ability Measure (FAAM) tool. [ Time Frame: One year ]
Original Secondary Outcome: Compare patient reported outcomes between the two groups using the Foot and Ankle Ability Measure (FAAM) tool. [ Time Frame: Evaluated at 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 1 year ]
Information By: Sanford Health
Dates:
Date Received: August 23, 2016
Date Started: April 2016
Date Completion: May 2019
Last Updated: September 19, 2016
Last Verified: September 2016
