This research study hopes to determine whether or not platelet rich plasma therapy improves healing time of moderate to severe ankle sprain in comparison to standard of care therapy.
The intention of this research project is to study a new treatment for severe ankle sprains.This new treatment is called Platelet Rich Plasma (PRP) therapy and involves injecting concentrated platelet's from a patient's own blood into the site of injury to aid healing. Platelets, aside from their clotting capabilities also serve a role in re-vascularization of tissue as well as collagen repair. PRP therapy has been used in sports medicine for treatment of chronic injuries but has yet to be proven effective in acute injury of a joint. The investigators are comparing treatment and placebo groups based on a subjective patient questionnaire and pain score administered on the day of injury and 2-3 days and 8-10 days follow up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
50ml of blood drawn into a 60cc with 10cc of anticoagulant is processed using MAGELLAN® Autologous Platelet (Arteriocyte Medical Systems, Cleveland Ohio)to separate out approximately 3-6 cc of platelet rich plasma, which is mixed with 1 cc of 1 % Lidocaine (xylocaine) and 1 cc of 0.25 % Marcaine (bupivacaine) and injected into the site of injury under USG guidance.
50ml of blood is drawn into a 60cc with 10cc of anticoagulant and is then discarded. 4 cc of saline solution is mixed with 1 cc of 1 % Lidocaine (xylocaine) and 1 cc of 0.25 % Marcaine (bupivacaine) and injected into the site of injury under USG guidance.
Einstein Healthcare Network
Philadelphia, Pennsylvania, United States
Change from baseline of LEFS score, a previous validated 80-point scale used to quantify lower extremity function.
The primary outcome of this investigation is change from baseline in LEFS score, a previous validated 80-point scale used to quantify lower extremity function. A difference of 9 points is considered clinically significant.
Time frame: Day 0; Day2-3; Day 8-10; Day30
Change in pain from baseline
Changes in level of pain from baseline was measured using VAS scale as well as comparing need for narcotics use at each follow up time point.
Time frame: Day 0; Day 2-3, Day 8-10, Day 30
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