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Trial record 58 of 347 for:    sprains and strains

Lateral Ankle Sprain and Platelet Rich Plasma

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ClinicalTrials.gov Identifier: NCT02609308
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon

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.


Condition or disease Intervention/treatment Phase
Ankle Injuries Other: Short leg cast Procedure: Platelet-rich plasma Not Applicable

Detailed Description:

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 treatment for lateral ankle sprains is conservative, but a 32% of the patients have chronic complications as edema, pain, and ankle instability. The treatment for acute sprains have good to excellent results. Ankle dorsiflexion allows the fibers of the affected ligament to approximate and gives stability of the ankle. The first phase of the treatment requires RICE therapy which includes rest, immobilization, compression with orthesis, and the use of non steroidal anti-inflammatory drug.

Platelet rich plasma is a sample of autologous blood with concentrations of platelets above baseline values, 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.

Purpose 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Use of platelet rich plasma in patients with ankle sprain
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Application of autologous platelet-rich plasma
Primary Purpose: Treatment
Official Title: Platelet Rich Plasma and Lateral Ankle Sprain. A Comparative Study
Actual Study Start Date : September 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Short leg cast
The patients in this group will be immobilize with a short leg cast for 14 days, and later they will be able to do physical rehabilitation and will be evaluated with American Orthopedic Foot and Ankle Society´s Ankle Hindfoot scale and Foot and Ankle Disability Index.
Other: Short leg cast
Immobilization with short leg cast with a dorsiflexed foot for two weeks

Experimental: Platelet-rich plasma
In this group, the patients will be receive a single dose of autologous platelet-rich plasma, and will be immobilized with a short leg cast. Posteriorly, they will be evaluated with American Orthopedic Foot and Ankle Society´s Ankle Hindfoot scale and Foot and Ankle Disability Index.
Procedure: Platelet-rich plasma
Will be applied 5 mL of autologous platelet-rich plasma under the lateral malleolus, over the anterior talofibular ligament




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Acute lateral ankle sprain with no more of 48 hours of evolution
  • First time lateral ankle sprain
  • Grade 2 or 3

Exclusion Criteria:

  • Associated pathologies like diabetes mellitus, osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, neurologic or psychiatric issues
  • Pregnant women
  • Previous surgery of the foot and ankle
  • Blood dyscrasias

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609308


Locations
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Mexico
Universidad Autonoma de Nuevo Leon
Monterrey, Nuevo Leon, Mexico, 64480
Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
Investigators
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Principal Investigator: Carlos Acosta-Olivo, MD, PhD Universidad Autonoma de Nuevo Leon

Publications of Results:

Other Publications:
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Responsible Party: Carlos A Acosta-Olivo, MD, PhD, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT02609308     History of Changes
Other Study ID Numbers: OR15-008
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon:
ankle sprain
platelet-rich plasma
ankle injuries

Additional relevant MeSH terms:
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Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries