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Lateral Ankle Sprain and Platelet Rich Plasma

Primary Purpose

Ankle Injuries

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Short leg cast
Platelet-rich plasma
Sponsored by
Universidad Autonoma de Nuevo Leon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Injuries focused on measuring ankle sprain, platelet-rich plasma, ankle injuries

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universidad Autonoma de Nuevo Leon

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Short leg cast

Platelet-rich plasma

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 17, 2015
Last Updated
September 30, 2019
Sponsor
Universidad Autonoma de Nuevo Leon
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1. Study Identification

Unique Protocol Identification Number
NCT02609308
Brief Title
Lateral Ankle Sprain and Platelet Rich Plasma
Official Title
Platelet Rich Plasma and Lateral Ankle Sprain. A Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Nuevo Leon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries
Keywords
ankle sprain, platelet-rich plasma, ankle injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Use of platelet rich plasma in patients with ankle sprain
Masking
InvestigatorOutcomes Assessor
Masking Description
Application of autologous platelet-rich plasma
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short leg cast
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Platelet-rich plasma
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Short leg cast
Intervention Description
Immobilization with short leg cast with a dorsiflexed foot for two weeks
Intervention Type
Procedure
Intervention Name(s)
Platelet-rich plasma
Intervention Description
Will be applied 5 mL of autologous platelet-rich plasma under the lateral malleolus, over the anterior talofibular ligament
Primary Outcome Measure Information:
Title
American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)
Description
Scale that evaluates pain, function and alignment of foot. The best score is 100 points, and the worst score are 0 points.
Time Frame
Sixth month
Secondary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Evaluate the pain in a scale of 0 to 10, when 0 is no pain, and 10 is the worst pain
Time Frame
Sixth month
Title
Foot and Ankle Disability Index (FADI)
Description
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.
Time Frame
Sixth month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Acosta-Olivo, MD, PhD
Organizational Affiliation
Universidad Autonoma de Nuevo Leon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Autonoma de Nuevo Leon
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64480
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
8951015
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. doi: 10.1302/0301-620x78b6.1283.
Results Reference
background
PubMed Identifier
20810936
Citation
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.
Results Reference
result
PubMed Identifier
23867186
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(Suppl 1):s229-34. doi: 10.2450/2013.0293-12. Epub 2013 Jul 3.
Results Reference
result
PubMed Identifier
18315959
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.
Results Reference
result
PubMed Identifier
19794217
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. doi: 10.5435/00124635-200910000-00002. Erratum In: J Am Acad Orthop Surg. 2010 Jan;18(1):17A.
Results Reference
result
PubMed Identifier
23874254
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.
Results Reference
result
PubMed Identifier
19282509
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.
Results Reference
result
PubMed Identifier
23712708
Citation
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.
Results Reference
result
PubMed Identifier
31640921
Citation
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.
Results Reference
derived

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Lateral Ankle Sprain and Platelet Rich Plasma

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