Lateral Ankle Sprain and Platelet Rich Plasma

NCT ID: NCT02609308

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-02-28

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 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 a Magnetic Resonance Image (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 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 beta-1, 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.

Conditions

Ankle Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Short leg cast

Intervention Type: OTHER

Immobilization with short leg cast with a dorsiflexed foot for two weeks

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.

Group Type: EXPERIMENTAL

Platelet-rich plasma

Intervention Type: PROCEDURE

Will be applied 5 mL of autologous platelet-rich plasma under the lateral malleolus, over the anterior talofibular ligament

Interventions

Short leg cast

Immobilization with short leg cast with a dorsiflexed foot for two weeks

Intervention Type: OTHER

Platelet-rich plasma

Will be applied 5 mL of autologous platelet-rich plasma under the lateral malleolus, over the anterior talofibular ligament

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Autonoma de Nuevo Leon

OTHER

Sponsor Role: lead

Responsible Party

Carlos A Acosta-Olivo

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos Acosta-Olivo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Autonoma de Nuevo Leon

Locations

Universidad Autonoma de Nuevo Leon

Monterrey, Nuevo León, Mexico

Countries

Mexico

References

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Reference Type: BACKGROUND

PMID: 8951015 (View on PubMed)

Anderson RB, Hunt KJ, McCormick JJ. Management of common sports-related injuries about the foot and ankle. J Am Acad Orthop Surg. 2010 Sep;18(9):546-56. doi: 10.5435/00124635-201009000-00006.

Reference Type: RESULT

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Bernuzzi G, Petraglia F, Pedrini MF, De Filippo M, Pogliacomi F, Verdano MA, Costantino C. Use of platelet-rich plasma in the care of sports injuries: our experience with ultrasound-guided injection. Blood Transfus. 2014 Jan;12 Suppl 1(Suppl 1):s229-34. doi: 10.2450/2013.0293-12. Epub 2013 Jul 3.

Reference Type: RESULT

PMID: 23867186 (View on PubMed)

Frei R, Biosca FE, Handl M, Trc T. [Conservative treatment using plasma rich in growth factors (PRGF) for injury to the ligamentous complex of the ankle]. Acta Chir Orthop Traumatol Cech. 2008 Feb;75(1):28-33. Czech.

Reference Type: RESULT

PMID: 18315959 (View on PubMed)

Hall MP, Band PA, Meislin RJ, Jazrawi LM, Cardone DA. Platelet-rich plasma: current concepts and application in sports medicine. J Am Acad Orthop Surg. 2009 Oct;17(10):602-8. doi: 10.5435/00124635-200910000-00002.

Reference Type: RESULT

PMID: 19794217 (View on PubMed)

Halpern BC, Chaudhury S, Rodeo SA. The role of platelet-rich plasma in inducing musculoskeletal tissue healing. HSS J. 2012 Jul;8(2):137-45. doi: 10.1007/s11420-011-9239-7. Epub 2012 Jan 18.

Reference Type: RESULT

PMID: 23874254 (View on PubMed)

Hammond JW, Hinton RY, Curl LA, Muriel JM, Lovering RM. Use of autologous platelet-rich plasma to treat muscle strain injuries. Am J Sports Med. 2009 Jun;37(6):1135-42. doi: 10.1177/0363546508330974. Epub 2009 Mar 12.

Reference Type: RESULT

PMID: 19282509 (View on PubMed)

Petersen W, Rembitzki IV, Koppenburg AG, Ellermann A, Liebau C, Bruggemann GP, Best R. Treatment of acute ankle ligament injuries: a systematic review. Arch Orthop Trauma Surg. 2013 Aug;133(8):1129-41. doi: 10.1007/s00402-013-1742-5. Epub 2013 May 28.

Reference Type: RESULT

PMID: 23712708 (View on PubMed)

Blanco-Rivera J, Elizondo-Rodriguez J, Simental-Mendia M, Vilchez-Cavazos F, Pena-Martinez VM, Acosta-Olivo C. Treatment of lateral ankle sprain with platelet-rich plasma: A randomized clinical study. Foot Ankle Surg. 2020 Oct;26(7):750-754. doi: 10.1016/j.fas.2019.09.004. Epub 2019 Sep 28.

Reference Type: DERIVED

PMID: 31640921 (View on PubMed)

Other Identifiers

OR15-008

Identifier Type: -

Identifier Source: org_study_id