An interventional study of Short leg cast and Platelet-rich plasma in Ankle Injuries, sponsored by Universidad Autonoma de Nuevo Leon. Completed at 1 site in Mexico. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-23.
Sponsored by Universidad Autonoma de Nuevo Leon · Not applicable, Interventional, and Treatment
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.
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.
217 studies on the registry are indexed under Sprains and Strains; 44 are open to participants now.
This study's enrollment of 21 is below the median of 60 across 166 interventional studies indexed under Sprains and Strains.
Browse Sprains and Strains studies →Universidad Autonoma de Nuevo Leon is the lead sponsor of 50 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
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
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
Immobilization with short leg cast with a dorsiflexed foot for two weeks
Will be applied 5 mL of autologous platelet-rich plasma under the lateral malleolus, over the anterior talofibular ligament
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
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
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
| Milestone | Short Leg Cast | Platelet-rich Plasma |
|---|---|---|
| Started | 10 | 11 |
| Completed | 10 | 11 |
| Not completed | 0 | 0 |
Scale that evaluates pain, function and alignment of foot. The best score is 100 points, and the worst score are 0 points.
| units on a scale | Short Leg Cast | Platelet-rich Plasma |
|---|---|---|
| American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS) | 97.8 ± 2.6 | 98.5 ± 3.4 |
Evaluate the pain in a scale of 0 to 10, when 0 is no pain, and 10 is the worst pain
| cm | Short Leg Cast | Platelet-rich Plasma |
|---|---|---|
| Visual Analogue Scale | 0.2 ± 0.40 | 0.1 ± 0.3 |
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.
| units on a scale | Short Leg Cast | Platelet-rich Plasma |
|---|---|---|
| Foot and Ankle Disability Index (FADI) | 135.3 ± 1.0 | 135.4 ± 1.0 |
Collected over All included patients were evaluated at 24 weeks after the protocol interventions were initiated.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Short Leg Cast | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Platelet-rich Plasma | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Continuous(Years) | Short Leg Cast | Platelet-rich Plasma | Total |
|---|---|---|---|
| Mean | 25.5 ± 15.4 | 27.9 ± 12.1 | 26.7 ± 16.1 |
| Sex: Female, Male(Participants) | Short Leg Cast | Platelet-rich Plasma | Total |
|---|---|---|---|
| Female | 6 | 4 | 10 |
| Male | 4 | 7 | 11 |
| Body Mass Index (BMI)(kg/m^2) | Short Leg Cast | Platelet-rich Plasma | Total |
|---|---|---|---|
| Mean | 25.4 ± 3.8 | 26.8 ± 3.5 | 26.3 ± 3.6 |
| Visual Analog Scale (VAS)(units on a scale) | Short Leg Cast | Platelet-rich Plasma | Total |
|---|---|---|---|
| Mean | 8.0 ± 1.3 | 7.5 ± 1.9 | 7.8 ± 1.7 |
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Universidad Autonoma de Nuevo Leon