Clinical Trial: Lateral Ankle Sprain and Platelet Rich Plasma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Platelet Rich Plasma and Lateral Ankle Sprain. A Comparative Study

Brief Summary:

Lateral ankle sprains are one of the most common in sports medicine. Considering the sprains in general, they represent an 85% of the ankle lesions. The incidence in high performance athletes range from 16 to 21%. It is estimated that 10,000 to 25,000 peoples suffers a lateral ankle sprain per hour in the United States. The objective of the treatment is to normalize the articular function and allow the patient to return to his or her normal physical activities. Platelet rich plasma is a simple of autologous blood with concentrations of platelets above baseline values. This is rich in platelet derived growth factor which stimulates cell replication, angiogenesis, transforming growth factor B1, fibroblast growth factor, epidermal growth factor, and insulin like growth factor. The risks of its applications are minimal and are usually involved with allergic reactions to other medications that are applied in combination with the platelet-rich plasma.

To establish that the use of platelet rich plasma and immobilization with a short leg cast in acute lateral ankle sprains will enhance an early recovery in comparison with just immobilization with the cast.


Detailed Summary:

Lateral ankle sprains are one of the most common in sports medicine. Considering the sprains in general, they represent an 85% of the ankle lesions. The incidence in high performance athletes range form 16 to 21%. It is estimated that 10,000 to 25,000 suffers a lateral ankle sprain per hour in the United States. The objective of the treatment is to normalize the articular function and allow the patient to return to his or her normal physical activities.

The lateral ligamentous complex of the ankle consists of three ligaments: the anterior talofibular, the calcaneofibular, and the posterior talofibular. The anterior talofibular ligament is the most affected. The patient describes a tear sensation in the ankle after an acute inversion of it. The injuries occur during physical activities as running. The patients presents with pain, swelling and tenderness over the affected ligaments. The proper diagnosis of the sprain includes anteroposterior, lateral and mortise view X rays of the affected ankle; if there is any suspicion of instability of the ankle, the physician shall order an MRI to evaluate the ligaments.

Lateral ankle sprains have been classified by numerous methods. By anatomic site, lateral ankle sprains can be classified as grade I: anterior talofibular sprain, grade II: anterior talofibular and calcaneofibular sprains, and grade III: anterior talofibular, calcaneofibular and posterior talofibular sprains. By clinical system the sprains can be classified as mild with minimal function loss, no limp, minimal swelling, tenderness, pain with reproduction of mechanism of injury; moderate with moderate functional loss, unable to rise on toes, limp when walking, localized swelling; and severe with diffuse tenderness, patient use crouches for ambulation.

Conventional treatmen
Sponsor: Universidad Autonoma de Nuevo Leon

Current Primary Outcome: American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale [ Time Frame: Eight weeks ]

Scale that evaluates pain, function and alignment of foot. The best score is 100 points, and the worst score are 0 points


Original Primary Outcome: Same as current

Current Secondary Outcome: Visual Analogue Scale [ Time Frame: eight weeks ]

Evaluate the pain in a scale of 0 to 10, when 0 is no pain, and 10 is the worst pain


Original Secondary Outcome: Same as current

Information By: Universidad Autonoma de Nuevo Leon

Dates:
Date Received: November 17, 2015
Date Started: September 2015
Date Completion:
Last Updated: May 4, 2017
Last Verified: May 2017