Lateral Ankle Sprain and Platelet Rich Plasma

• Sponsor: Universidad Autonoma de Nuevo Leon (Other)
• Overall Status: Completed
• CT.gov ID: NCT02609308
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.1
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ankle Injuries	Other: Short leg cast; Procedure: Platelet-rich plasma	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Use of platelet rich plasma in patients with ankle sprainUse of platelet rich plasma in patients with ankle sprain
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: Application of autologous platelet-rich plasma
• Primary Purpose: Treatment
• Official Title: Platelet Rich Plasma and Lateral Ankle Sprain. A Comparative Study
• Actual Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Other: Short leg cast; Immobilization with short leg cast with a dorsiflexed foot for two weeks
Experimental: 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.	Procedure: Platelet-rich plasma; Will be applied 5 mL of autologous platelet-rich plasma under the lateral malleolus, over the anterior talofibular ligament

Outcome Measures

Primary Outcome Measures

1. American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS) [Sixth month]

   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

1. Visual Analogue Scale [Sixth month]

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

2. Foot and Ankle Disability Index (FADI) [Sixth month]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad Autonoma de Nuevo Leon	Monterrey	Nuevo Leon	Mexico	64480

Sponsors and Collaborators

• Universidad Autonoma de Nuevo Leon

Investigators

• Principal Investigator: Carlos Acosta-Olivo, MD, PhD, Universidad Autonoma de Nuevo Leon

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Carlos A Acosta-Olivo, MD, PhD, Universidad Autonoma de Nuevo Leon
• ClinicalTrials.gov Identifier: NCT02609308
• Other Study ID Numbers: OR15-008
• First Posted: Nov 20, 2015
• Last Update Posted: Oct 23, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Carlos A Acosta-Olivo, MD, PhD, Universidad Autonoma de Nuevo Leon: ankle sprain; platelet-rich plasma; ankle injuries
• Additional relevant MeSH terms: Sprains and Strains; Ankle Injuries

Study Results

Participant Flow

Arm/Group Title	Short Leg Cast	Platelet-rich Plasma
Arm/Group 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. Short leg cast: Immobilization with short leg cast with a dorsiflexed foot for two weeks.	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.
Period Title: Overall Study
STARTED	10	11
COMPLETED	10	11
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Short Leg Cast	Platelet-rich Plasma	Total
Arm/Group 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. Short leg cast: Immobilization with short leg cast with a dorsiflexed foot for two weeks.	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 of all reporting groups
Overall Participants	10	11	21
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	25.5 (15.4)	27.9 (12.1)	26.7 (16.1)
Sex: Female, Male (Count of Participants)
Female	6 60%	4 36.4%	10 47.6%
Male	4 40%	7 63.6%	11 52.4%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	25.4 (3.8)	26.8 (3.5)	26.3 (3.6)
Visual Analog Scale (VAS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	8.0 (1.3)	7.5 (1.9)	7.8 (1.7)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Short Leg Cast	Platelet-rich Plasma
Arm/Group 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. Short leg cast: Immobilization with short leg cast with a dorsiflexed foot for two weeks.	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.
Measure Participants	10	11
Mean (Standard Deviation) [units on a scale]	97.8 (2.6)	98.5 (3.4)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Short Leg Cast	Platelet-rich Plasma
Arm/Group 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. Short leg cast: Immobilization with short leg cast with a dorsiflexed foot for two weeks.	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.
Measure Participants	10	11
Mean (Standard Deviation) [cm]	0.2 (0.40)	0.1 (0.3)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Short Leg Cast	Platelet-rich Plasma
Arm/Group 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. Short leg cast: Immobilization with short leg cast with a dorsiflexed foot for two weeks.	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.
Measure Participants	10	11
Mean (Standard Deviation) [units on a scale]	135.3 (1.0)	135.4 (1.0)

Adverse Events

Time Frame	All included patients were evaluated at 24 weeks after the protocol interventions were initiated.
Arm/Group Title	Short Leg Cast		Platelet-rich Plasma
Arm/Group 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. Short leg cast: Immobilization with short leg cast with a dorsiflexed foot for two weeks.		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.
All Cause Mortality
	Short Leg Cast		Platelet-rich Plasma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/11 (0%)
Serious Adverse Events
	Short Leg Cast		Platelet-rich Plasma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Short Leg Cast		Platelet-rich Plasma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/11 (0%)

Limitations/Caveats

The diagnosis of Lateral Ankle Sprain was based on a clinical classification. We didn't use an Ultrasound scan, to perform the application of the Platelet Rich Plasma, or to assess morphologically the affected area before and after the treatment

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.