Trial Outcomes & Findings for Lateral Ankle Sprain and Platelet Rich Plasma (NCT NCT02609308)
NCT ID: NCT02609308
Last Updated: 2019-10-23
Results Overview
Scale that evaluates pain, function and alignment of foot. The best score is 100 points, and the worst score are 0 points.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Sixth month
Results posted on
2019-10-23
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lateral Ankle Sprain and Platelet Rich Plasma
Baseline characteristics by cohort
| Measure |
Short Leg Cast
n=10 Participants
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.
|
Platelet-rich Plasma
n=11 Participants
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.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.5 Years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
27.9 Years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
26.7 Years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
25.4 kg/m^2
STANDARD_DEVIATION 3.8 • n=5 Participants
|
26.8 kg/m^2
STANDARD_DEVIATION 3.5 • n=7 Participants
|
26.3 kg/m^2
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Visual Analog Scale (VAS)
|
8.0 units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
7.5 units on a scale
STANDARD_DEVIATION 1.9 • n=7 Participants
|
7.8 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Sixth monthScale that evaluates pain, function and alignment of foot. The best score is 100 points, and the worst score are 0 points.
Outcome measures
| Measure |
Short Leg Cast
n=10 Participants
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.
|
Platelet-rich Plasma
n=11 Participants
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.
|
|---|---|---|
|
American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)
|
97.8 units on a scale
Standard Deviation 2.6
|
98.5 units on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Sixth monthEvaluate the pain in a scale of 0 to 10, when 0 is no pain, and 10 is the worst pain
Outcome measures
| Measure |
Short Leg Cast
n=10 Participants
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.
|
Platelet-rich Plasma
n=11 Participants
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.
|
|---|---|---|
|
Visual Analogue Scale
|
0.2 cm
Standard Deviation 0.40
|
0.1 cm
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Short Leg Cast
n=10 Participants
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.
|
Platelet-rich Plasma
n=11 Participants
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.
|
|---|---|---|
|
Foot and Ankle Disability Index (FADI)
|
135.3 units on a scale
Standard Deviation 1.0
|
135.4 units on a scale
Standard Deviation 1.0
|
Adverse Events
Short Leg Cast
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Platelet-rich Plasma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carlos Acosta-Olivo, PhD
Universidad Autónoma de Nuevo León
Phone: +52 81 8347-3056
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place