Lateral Ankle Sprain and Platelet Rich Plasma

Ankle Injuries Clinical Trial

Official title:

Platelet Rich Plasma and Lateral Ankle Sprain. A Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609308
• Other study ID #: OR15-008
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: February 2017

Study information

• Verified date: September 2019
• Source: Universidad Autonoma de Nuevo Leon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Sprains and Strains

Intervention

Other:
• Short leg cast
Immobilization with short leg cast with a dorsiflexed foot for two weeks

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

Locations

Country	Name	City	State
Mexico	Universidad Autonoma de Nuevo Leon	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Nuevo Leon

Country where clinical trial is conducted

Mexico, 

References & Publications (8)

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. Review. — View Citation

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:s229-34. doi: 10.24 — View Citation

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. — View Citation

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. Review. Erratum in: J Am Acad Orthop Surg. 2010 Jan;18(1):17A. — View Citation

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. — View Citation

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. — View Citation

Petersen W, Rembitzki IV, Koppenburg AG, Ellermann A, Liebau C, Brüggemann 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. Rev — View Citation

van Dijk CN, Lim LS, Bossuyt PM, Marti RK. Physical examination is sufficient for the diagnosis of sprained ankles. J Bone Joint Surg Br. 1996 Nov;78(6):958-62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)	Scale that evaluates pain, function and alignment of foot. The best score is 100 points, and the worst score are 0 points.	Sixth month
Secondary	Visual Analogue Scale	Evaluate the pain in a scale of 0 to 10, when 0 is no pain, and 10 is the worst pain	Sixth month
Secondary	Foot and Ankle Disability Index (FADI)	The Foot and Ankle Disability Index (FADI) assesses activities such as standing, walking on flat or uneven surfaces, walking on inclines, and the length of time of walking without difficulty. It also includes a section for sports activities and ankle or foot pain (or both). The highest score is 136 points, indicating the best clinical situation, free of pain and limitations, while the lowest score is 0.	Sixth month