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N/A N=21 Randomized Double-blind Treatment

Lateral Ankle Sprain and Platelet Rich Plasma

Ankle Injuries

Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS) — 97.8; 98.5 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Short leg cast (Other); Platelet-rich plasma (Procedure)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Universidad Autonoma de Nuevo Leon
Primary completion
Dec 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)
97.8; 98.5
SECONDARY
Visual Analogue Scale
0.2; 0.1
SECONDARY
Foot and Ankle Disability Index (FADI)
135.3; 135.4

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02609308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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