The effect of platelet rich plasma (PRP) on pain and function in patients with lateral ankle sprain after modified Brostrom surgery, a randomized clinical trial
The effect of platelet rich plasma on pain and function in patients with lateral ankle sprain after modified Brostrom surgery
Design
A randomized, single blinded, clinical trial with a control group on 20 patients. Randomization will be performed based on patients' visit days according to even and odd days of the week.
Settings and conduct
Initially, we will record the following items for patients who meet the inclusion criteria: Height, weight, Body mass index, pain by visual analog scale (VAS), ankle function by American Orthopedic Foot and Ankle Score (AOFAS), and Foot and Ankle Ability Measure (FAAM). Then, for both groups, Brostrom surgery will be performed by an orthopedic surgeon at Akhtar Hospital in Tehran. One week later, along with the routine treatment, the intervention group will be injected with 5ccs of PRP, and the control group with 5ccs of sterile normal saline at the lateral ankle ligament surgery site under ultrasound guide. VAS, AOFAS, and FAAM in the first visit, 1st, 5th, 15th, and 25th week after surgery, as well as return to normal walking and painless weight bearing time, will be recorded for both groups.
Participants/Inclusion and exclusion criteria
Patients with lateral ankle sprain grade 3; No history of ankle surgery, ankle osteoarthritis, inflammatory diseases, and confounders in the study results, and no ankle deformities.
Intervention groups
Seven days after surgery, a certain volume of peripheral blood will be taken from each patient. We will discard the control group blood, but the intervention group blood will be converted to PRP by a trained person with a standard kit. The intervention group will receive routine treatment along with PRP. The control group will receive normal saline (as placebo) along with routine treatment.
Main outcome variables
Ankle pain by VAS; ankle function by AOFAS and FAAM; Return to Walk and Full Weight Bearing time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200307046714N1
Registration date:2022-01-15, 1400/10/25
Registration timing:prospective
Last update:2022-01-15, 1400/10/25
Update count:2
Registration date
2022-01-15, 1400/10/25
Registrant information
Name
Hooshmand Zarei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4409 8132
Email address
hooshmand.z1994@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-20, 1400/10/30
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of platelet rich plasma (PRP) on pain and function in patients with lateral ankle sprain after modified Brostrom surgery, a randomized clinical trial
Public title
The effect of platelet rich plasma in lateral ankle sprain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Grade 3 (severe) ligament injury based on clinical and imaging criteria and no ankle fracture
Exclusion criteria:
Pregnancy
Breastfeeding
Those who intend to become pregnant
History of peripheral vascular diseases
Rheumatoid Arthritis
Knee or ankle osteoarthritis
Ankylosing spondylitis
Foot deformities
Diabetes
Neurological disorders
Psychiatric disorders
History of surgery and active infection at the site of injury
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants were unaware of their placement in the study group (platelet rich plasma or normal saline solution).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2021-02-21, 1399/12/03
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.1264
Health conditions studied
1
Description of health condition studied
lateral ankle sprain
ICD-10 code
S93.40
ICD-10 code description
Sprain of unspecified ligament of ankle
Primary outcomes
1
Description
Determination of ankle pain
Timepoint
The first visit, the 1st, 5th, 15th, and 25th week after surgery
Method of measurement
Questionnaire (VAS)
2
Description
Determination of ankle function
Timepoint
The first visit, the 1st, 5th, 15th, and 25th week after surgery
Method of measurement
Questionnaire (AOFAS), Questionnaire (FAAM)
3
Description
Determine the ankle range of motion
Timepoint
The first visit, the 1st, 5th, 15th, and 25th week after surgery
Method of measurement
Manual joiniometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group of patients, 50 ccs of peripheral blood will be taken from each patient by a 50cc syringe, then centrifuged and converted to 5 ccs PRP. PRP solution will be combined with 1cc of 1% lidocaine and then injected into the site of lateral ligament surgery under ultrasound guide by a physician.
Category
Treatment - Other
2
Description
Control group: For patients in this group, 50 ccs of peripheral blood will be taken from each patient but discarded. Then, 5ccs of 0.9% sterile saline solution combined with 1cc of 1% lidocaine will be injected into the site of lateral ligament surgery by a physician under an ultrasound guide.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
Hooshmand Zarei, MD
Street address
Sharifi Manesh St., Poule Roomi Ave, Shariati St.
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2243 9982
Fax
+98 21 2243 9784
Email
hooshmand.z1994@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi, Ph.D
Street address
Vice-Chancellor in Research Affairs, 5th Floor, Bldg No.2 Shahid Beheshti University of medical sciences Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Fax
+98 21 2243 9981
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hooshmand Zarei, MD
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Unit 6, No.19, 3th St., North Shaghayegh Blvd., Ayatollah Kashani St., North Sazman Barnameh
City
Tehran
Province
Tehran
Postal code
1483877468
Phone
+98 21 4409 8132
Email
hooshmand.z1994@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Sabbaghzadeh Irani, MD
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shohadaye Tajrish Hospital, Tajrish Sq
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
dramirsabbaghzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hooshmand Zarei, MD
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Unit 6, No.19, 3th St., North Shaghayegh Blvd., Ayatollah Kashani St., North Sazman Barnameh
City
Tehran
Province
Tehran
Postal code
1483877468
Phone
+98 21 4409 8132
Email
hooshmand.z1994@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available