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Lateral Ankle Sprain and Platelet Rich Plasma

Platelet Rich Plasma and Lateral Ankle Sprain. A Comparative Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02609308
Enrollment
21
Registered
2015-11-20
Start date
2015-09-30
Completion date
2017-02-28
Last updated
2019-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Injuries

Keywords

ankle sprain, platelet-rich plasma, ankle injuries

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.

Interventions

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

PROCEDUREPlatelet-rich plasma

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

Sponsors

Universidad Autonoma de Nuevo Leon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Application of autologous platelet-rich plasma

Intervention model description

Use of platelet rich plasma in patients with ankle sprain

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)Sixth monthScale that evaluates pain, function and alignment of foot. The best score is 100 points, and the worst score are 0 points.

Secondary

MeasureTime frameDescription
Visual Analogue ScaleSixth monthEvaluate 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)Sixth monthThe 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.

Countries

Mexico

Participant flow

Participants by arm

ArmCount
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. Short leg cast: Immobilization with short leg cast with a dorsiflexed foot for two weeks.
10
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. Platelet-rich plasma: Will be applied 5 mL of autologous platelet-rich plasma under the lateral malleolus, over the anterior talofibular ligament.
11
Total21

Baseline characteristics

CharacteristicTotalShort Leg CastPlatelet-rich Plasma
Age, Continuous26.7 Years
STANDARD_DEVIATION 16.1
25.5 Years
STANDARD_DEVIATION 15.4
27.9 Years
STANDARD_DEVIATION 12.1
Body Mass Index (BMI)26.3 kg/m^2
STANDARD_DEVIATION 3.6
25.4 kg/m^2
STANDARD_DEVIATION 3.8
26.8 kg/m^2
STANDARD_DEVIATION 3.5
Sex: Female, Male
Female
10 Participants6 Participants4 Participants
Sex: Female, Male
Male
11 Participants4 Participants7 Participants
Visual Analog Scale (VAS)7.8 units on a scale
STANDARD_DEVIATION 1.7
8.0 units on a scale
STANDARD_DEVIATION 1.3
7.5 units on a scale
STANDARD_DEVIATION 1.9

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 11
other
Total, other adverse events
0 / 100 / 11
serious
Total, serious adverse events
0 / 100 / 11

Outcome results

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.

Time frame: Sixth month

ArmMeasureValue (MEAN)Dispersion
Short Leg CastAmerican Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)97.8 units on a scaleStandard Deviation 2.6
Platelet-rich PlasmaAmerican Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)98.5 units on a scaleStandard Deviation 3.4
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.

Time frame: Sixth month

ArmMeasureValue (MEAN)Dispersion
Short Leg CastFoot and Ankle Disability Index (FADI)135.3 units on a scaleStandard Deviation 1
Platelet-rich PlasmaFoot and Ankle Disability Index (FADI)135.4 units on a scaleStandard Deviation 1
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

Time frame: Sixth month

ArmMeasureValue (MEAN)Dispersion
Short Leg CastVisual Analogue Scale0.2 cmStandard Deviation 0.4
Platelet-rich PlasmaVisual Analogue Scale0.1 cmStandard Deviation 0.3

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026