NCT02609308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

October 23, 2019

Completed
Last Updated

October 23, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

November 17, 2015

Results QC Date

September 29, 2017

Last Update Submit

September 30, 2019

Conditions

Ankle Injuries

Keywords

ankle sprainplatelet-rich plasmaankle injuries

Outcome Measures

Primary Outcomes (1)

  • 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.

    Sixth month

Secondary Outcomes (2)

  • Visual Analogue Scale

    Sixth month

  • Foot and Ankle Disability Index (FADI)

    Sixth month

Study Arms (2)

Short leg cast

ACTIVE COMPARATOR

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

Platelet-rich plasma

EXPERIMENTAL

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

Interventions

Short leg castOTHER

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

Short leg cast
Platelet-rich plasmaPROCEDURE

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

Platelet-rich plasma

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Acute lateral ankle sprain with no more of 48 hours of evolution
  • First time lateral ankle sprain
  • Grade 2 or 3

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Autonoma de Nuevo Leon

Monterrey, Nuevo León, 64480, Mexico

Location

Related Publications (9)

  • 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. doi: 10.1302/0301-620x78b6.1283.

    PMID: 8951015BACKGROUND

  • Anderson RB, Hunt KJ, McCormick JJ. Management of common sports-related injuries about the foot and ankle. J Am Acad Orthop Surg. 2010 Sep;18(9):546-56. doi: 10.5435/00124635-201009000-00006.

    PMID: 20810936RESULT

  • Bernuzzi G, Petraglia F, Pedrini MF, De Filippo M, Pogliacomi F, Verdano MA, Costantino C. Use of platelet-rich plasma in the care of sports injuries: our experience with ultrasound-guided injection. Blood Transfus. 2014 Jan;12 Suppl 1(Suppl 1):s229-34. doi: 10.2450/2013.0293-12. Epub 2013 Jul 3.

    PMID: 23867186RESULT

  • Frei R, Biosca FE, Handl M, Trc T. [Conservative treatment using plasma rich in growth factors (PRGF) for injury to the ligamentous complex of the ankle]. Acta Chir Orthop Traumatol Cech. 2008 Feb;75(1):28-33. Czech.

    PMID: 18315959RESULT

  • Hall MP, Band PA, Meislin RJ, Jazrawi LM, Cardone DA. Platelet-rich plasma: current concepts and application in sports medicine. J Am Acad Orthop Surg. 2009 Oct;17(10):602-8. doi: 10.5435/00124635-200910000-00002.

    PMID: 19794217RESULT

  • Halpern BC, Chaudhury S, Rodeo SA. The role of platelet-rich plasma in inducing musculoskeletal tissue healing. HSS J. 2012 Jul;8(2):137-45. doi: 10.1007/s11420-011-9239-7. Epub 2012 Jan 18.

    PMID: 23874254RESULT

  • Hammond JW, Hinton RY, Curl LA, Muriel JM, Lovering RM. Use of autologous platelet-rich plasma to treat muscle strain injuries. Am J Sports Med. 2009 Jun;37(6):1135-42. doi: 10.1177/0363546508330974. Epub 2009 Mar 12.

    PMID: 19282509RESULT

  • Petersen W, Rembitzki IV, Koppenburg AG, Ellermann A, Liebau C, Bruggemann GP, Best R. Treatment of acute ankle ligament injuries: a systematic review. Arch Orthop Trauma Surg. 2013 Aug;133(8):1129-41. doi: 10.1007/s00402-013-1742-5. Epub 2013 May 28.

    PMID: 23712708RESULT

  • Blanco-Rivera J, Elizondo-Rodriguez J, Simental-Mendia M, Vilchez-Cavazos F, Pena-Martinez VM, Acosta-Olivo C. Treatment of lateral ankle sprain with platelet-rich plasma: A randomized clinical study. Foot Ankle Surg. 2020 Oct;26(7):750-754. doi: 10.1016/j.fas.2019.09.004. Epub 2019 Sep 28.

    PMID: 31640921DERIVED

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Limitations and 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

Results Point of Contact

Title
Carlos Acosta-Olivo, PhD
Organization
Universidad Autónoma de Nuevo León
dr.carlosacosta@gmail.com
+52 81 8347-3056

Study Officials

  • Carlos Acosta-Olivo, MD, PhD

    Universidad Autonoma de Nuevo Leon

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Application of autologous platelet-rich plasma
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Use of platelet rich plasma in patients with ankle sprain
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 20, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

October 23, 2019

Results First Posted

October 23, 2019

Record last verified: 2019-09

Locations

ME(1)