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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

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History
# Registration date Revision Id
3 2022-09-07, 1401/06/16 239482
2 2022-06-02, 1401/03/12 232105
1 2022-01-15, 1400/10/25 213171
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  • Protocol summary

    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.
    A randomized, single-blinded, clinical trial with a control group on 20 patients. Randomization will be performed using an online block randomization tool (www.sealedenvelope.com).
    کارآزمایی بالینی دارای گروه کنترل، یک سویه کور، تصادفی شده، بر روی 20 بیمار. تصادفی سازی بر اساس روز مراجعه بیماران طبق روزهای زوج و فرد هفته صورت میگیرد.
    کارآزمایی بالینی دارای گروه کنترل، یک سویه کور، تصادفی شده، بر روی 20 بیمار. تصادفی سازی با استفاده از ابزار تصادفی سازی بلوک آنلاین (www.sealedenvelope.com) انجام خواهد شد.
    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.
    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 ankle total range of motion (total ROM). Then, Brostrom surgery will be performed by an orthopedic surgeon for both groups at Akhtar Hospital in Tehran. One week postoperatively, along with the routine treatment, the intervention group will be injected with 5 cc of PRP at the ligament surgery site under ultrasound guide. two and six weeks postoperatively, 5 cc of PRP will be injected into the tibiotalar joint under ultrasound guide for the intervention group. The control group also receives only routine treatment after surgery. VAS, AOFAS, and total ROM will be recorded at the first visit and three months after surgery for both groups.
    ابتدا موارد زیر را برای بیمارانی که دارای معیارهای ورود هستند ثبت میکنیم: قد، وزن، شاخص توده بدنی، درد به وسیله مقياس ديداری درد (VAS) ، عملکرد مچ پا به وسیله امتیاز ارتوپدی پا و مچ پا آمریکایی (AOFAS) و مقياس سنجش توانايي پا و مچ پا (FAAM). سپس برای هر دو گروه جراحی بروشتروم توسط یک جراح ارتوپد در بیمارستان اختر تهران انجام خواهد شد. یک هفته بعد، در کنار درمان روتین، برای گروه مداخله 5 سی سی پلاسمای غنی از پلاکت و برای گروه کنترل 5 سی سی نرمال سالین استریل در محل جراحی لیگامان خارجی، تحت گاید سونوگرافی تزریق خواهد شد. VAS، AOFAS و FAAM در اولین مراجعه، هفته اول، پنجم، پانزدهم و بیست و پنجم بعد از جراحی و هم چنین زمان بازگشت به راه رفتن عادی و وزن گذاری بدون درد برای هر دو گروه ثبت خواهد شد.
    ابتدا موارد زیر را برای بیمارانی که دارای معیارهای ورود هستند ثبت میکنیم: قد، وزن، شاخص توده بدنی، درد به وسیله مقياس ديداری درد (VAS) ، عملکرد مچ پا به وسیله امتیاز ارتوپدی پا و مچ پا آمریکایی (AOFAS) و دامنه حرکتی کل مچ پا ( total ROM). سپس برای هر دو گروه جراحی بروشتروم توسط یک جراح ارتوپد در بیمارستان اختر تهران انجام خواهد شد. یک هفته بعد از جراحی در کنار درمان روتین، برای گروه مداخله 5 سی سی پلاسمای غنی از پلاکت درمحل جراحی لیگامان خارجی تحت گاید سونوگرافی تزریق خواهد شد. در هفته دوم و ششم بعد از جراحی نیز برای این گروه 5 سی سی پلاسمای غنی از پلاکت درمحل مفصل تیبیوتالار تحت گاید سونوگرافی تزریق خواهد شد. گروه کنترل نیز فقط درمان روتین بعد از جراحی را دریافت میکند. VAS، AOFAS و total ROM در اولین مراجعه و سه ماه بعد از جراحی برای هر دو گروه ثبت خواهد شد.
    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.
    One, two, and six weeks after surgery, a certain volume of peripheral blood will be taken from each patient in the intervention group and will be converted into PRP by a trained person using a standard kit. The intervention group receives routine treatment along with PRP. The control group received only routine treatment.
    هفت روز بعد از جراحی، از هر بیمار حجم معینی خون محیطی گرفته میشود. خون گروه کنترل را دور خواهیم ریخت ولی خون گروه مداخله توسط یک فرد اموزش دیده بوسیله کیت استاندارد به پلاسمای غنی از پلاکت تبدیل خواهد شد.گروه مداخله درمان روتین را در کنار پلاسمای غنی از پلاکت دریافت میکند. گروه کنترل نرمال سالین (به عنوان پلاسبو) را در کنار درمان روتین دریافت میکند.
    یک ، دو و شش هفته بعد از جراحی، از هر بیمار گروه مداخله حجم معینی خون محیطی گرفته میشود و توسط یک فرد اموزش دیده بوسیله کیت استاندارد به پلاسمای غنی از پلاکت تبدیل خواهد شد. گروه مداخله درمان روتین را در کنار پلاسمای غنی از پلاکت دریافت میکند. گروه کنترل فقط درمان روتین را دریافت میکند.
    Ankle pain by VAS; ankle function by AOFAS and FAAM; Return to Walk and Full Weight Bearing time
    Ankle pain by VAS; ankle function by AOFAS and total ROM
    درد مچ پا به وسیله مقياس ديداری درد ؛ عملکرد مچ پا به وسیله امتیاز ارتوپدی پا و مچ پا آمریکایی و مقياس سنجش توانايي پا و مچ پا؛ زمان بازگشت به راه رفتن عادی و وزن گذاری بدون درد
    درد مچ پا به وسیله مقياس ديداری درد ؛ عملکرد مچ پا به وسیله امتیاز ارتوپدی پا و مچ پا آمریکایی و دامنه حرکتی کل مچ پا

  • General information

    Not randomized
    Randomized
    1
    1
    1
    1
    1
    empty
    Randomization changed from pseudorandomized to randomized. Participants were not blinded, but the outcome assessor, researchers, and data analysts were blinded. The control group did not receive a placebo injection. The number of platelet-rich plasma injections increased to 3 for the intervention group. Lidocaine was not added to the platelet-rich plasma solution. The study changed from double-blinded to single-blinded.In the variables section, the FAAM variable was deleted. patients Follow-up was performed only three months after surgery.
    empty
    تصادفی سازی از غیراختصاصی به اختصاصی تغییر یافت. کورسازی شرکت‌کنندگان به عدم کورسازی تغییر یافت، ولی کورسازی برای ارزیابی‌کننده پیامد، محققان و تحلیل‌کننده داده‌ها انجام شد. تزریق پلاسبو برای گروه کنترل حذف شد. تعداد تزریقات پلاسمای غنی از پلاکت برای گروه مداخله به ۳ تزریق افزایش یافت. اضافه کردن لیدوکایین به محلول پلاسمای غنی از پلاکت انجام نشد. مطالعه از دوسوکور به یک سو کور تغییر یافت. در بخش متغییر ها، متغیر مقياس سنجش توانايي پا و مچ پا (FAAM) حذف شد. فالو اپ بیماران فقط 3 ماه بعد از جراحی انجام شد.
    Randomization was performed using an online block randomization tool (www.sealedenvelope.com), with a variable block size of 2 or 4, and stratified based on age (≥40 or < 40 years).
    تصادفی‌سازی با استفاده از ابزار تصادفی‌سازی بلوکی آنلاین (www.sealedenvelope.com)، با اندازه بلوک متغیر 2 یا 4، و طبقه بندی بر اساس سن (≥40 یا <40 سال) انجام شد.
    In this study, participants were unaware of their placement in the study group (platelet rich plasma or normal saline solution).
    Evaluation of the outcomes will be performed by a foot and ankle surgeon who is unaware of patients’ randomization. The physiotherapist who will prescribe the physiotherapy program and the researchers who will perform the statistical analysis will also be blinded to the randomization.
    در این مطالعه شرکت کننده از قرار گیری خود در گروه مطالعاتی (تزریق پلاسمای غنی از پلاکت یا محلول نرمال سالین) بی اطلاع است.
    ارزیابی نتایج توسط یک جراح پا و مچ پا که از تصادفی‌سازی بیماران بی‌اطلاع است، انجام خواهد شد. فیزیوتراپیستی که برنامه فیزیوتراپی را تجویز خواهد کرد و محققانی که تجزیه و تحلیل آماری را انجام خواهند داد نیز از تصادفی سازی بی اطلاع خواهند بود.

  • Primary outcomes

    #1
    The first visit, the 1st, 5th, 15th, and 25th week after surgery
    The first visit, three months after surgery
    جلسه اول ویزیت، هفته اول، پنجم، پانزدهم و بیست و پنجم بعد از جراجی
    جلسه اول ویزیت، سه ماه بعد از جراجی
    #2
    تعیین عملکرد مچ پا بوسیله AOFAS و FAAM
    تعیین عملکرد مچ پا بوسیله AOFAS
    The first visit, the 1st, 5th, 15th, and 25th week after surgery
    The first visit, three months after surgery
    جلسه اول ویزیت، هفته اول، پنجم، پانزدهم و بیست و پنجم بعد از جراجی
    جلسه اول ویزیت، سه ماه بعد از جراجی
    Questionnaire (AOFAS), Questionnaire (FAAM)
    Questionnaire (AOFAS)
    پرسشنامه ( AOFAS)، پرسشنامه ( FAAM)
    پرسشنامه ( AOFAS)
    #3
    Determine the ankle range of motion
    Determine the ankle total range of motion (total ROM)
    تعیین دامنه حرکتی مچ پا
    تعیین دامنه حرکتی کل مچ پا
    The first visit, the 1st, 5th, 15th, and 25th week after surgery
    The first visit, three months after surgery
    جلسه اول ویزیت، هفته اول، پنجم، پانزدهم و بیست و پنجم بعد از جراجی
    جلسه اول ویزیت، سه ماه بعد از جراجی

  • Intervention groups

    #1
    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.
    Intervention group: In this group of patients, 50 ccs of peripheral blood will be taken from each patient by a 50cc syringe in the first, second, and sixth weeks after surgery, then centrifuged and converted to 5 ccs PRP. The first PRP solution will be injected into the site of lateral ligament surgery under ultrasound guide by a physician. The second and third injections will be also injected into the tibiotalar joint by the same physician under ultrasound guide.
    گروه مداخله: در این گروه از هر بیمار cc 50 خون محیطی توسط سرنگ 50 سی سی گرفته سپس سانتریفیوژ می شود و به 5 سی سی PRP تبدیل شده و همراه با 1 cc لیدوکائین 1 % ترکیب و در محل جراحی لیگامان خارجی، تحت گاید سونوگرافی توسط پزشک تزریق میشود.
    گروه مداخله: در این گروه از هر بیمار cc 50 خون محیطی توسط سرنگ 50 سی سی در هفته های اول، دوم و ششم پس از جراحی گرفته، سپس سانتریفیوژ می شود و به 5 سی سی PRP تبدیل میشود. تزریق اول در محل جراحی لیگامان، تحت گاید سونوگرافی توسط پزشک تزریق میشود. تزریق دوم و سوم نیز در محل مفصل تیبیوتالار تحت گاید سونوگرافی توسط همان پزشک تزریق میشود.
    #2
    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.
    Control group: This group receives only routine treatment after surgery.
    گروه کنترل: در این گروه از هر بیمار cc 50 خون محیطی گرفته میشود ولی دور ریخته میشود. برای این گروه 5 سی سی از محلول سالین 0.9 % استریل همراه با 1 cc لیدوکائین 1 % تحت گاید سونوگرافی در محل جراحی لیگامان خارجی توسط پزشک تزریق میشود.
    گروه کنترل: این گروه تنها درمان روتین بعد از جراحی را دریافت میکند.

Protocol summary

Study aim
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 using an online block randomization tool (www.sealedenvelope.com).
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 ankle total range of motion (total ROM). Then, Brostrom surgery will be performed by an orthopedic surgeon for both groups at Akhtar Hospital in Tehran. One week postoperatively, along with the routine treatment, the intervention group will be injected with 5 cc of PRP at the ligament surgery site under ultrasound guide. two and six weeks postoperatively, 5 cc of PRP will be injected into the tibiotalar joint under ultrasound guide for the intervention group. The control group also receives only routine treatment after surgery. VAS, AOFAS, and total ROM will be recorded at the first visit and three months after surgery 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
One, two, and six weeks after surgery, a certain volume of peripheral blood will be taken from each patient in the intervention group and will be converted into PRP by a trained person using a standard kit. The intervention group receives routine treatment along with PRP. The control group received only routine treatment.
Main outcome variables
Ankle pain by VAS; ankle function by AOFAS and total ROM

General information

Reason for update
Randomization changed from pseudorandomized to randomized. Participants were not blinded, but the outcome assessor, researchers, and data analysts were blinded. The control group did not receive a placebo injection. The number of platelet-rich plasma injections increased to 3 for the intervention group. Lidocaine was not added to the platelet-rich plasma solution. The study changed from double-blinded to single-blinded.In the variables section, the FAAM variable was deleted. patients Follow-up was performed only three months after surgery.
Acronym
IRCT registration information
IRCT registration number: IRCT20200307046714N1
Registration date: 2022-01-15, 1400/10/25
Registration timing: prospective

Last update: 2022-07-03, 1401/04/12
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
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed using an online block randomization tool (www.sealedenvelope.com), with a variable block size of 2 or 4, and stratified based on age (≥40 or < 40 years).
Blinding (investigator's opinion)
Single blinded
Blinding description
Evaluation of the outcomes will be performed by a foot and ankle surgeon who is unaware of patients’ randomization. The physiotherapist who will prescribe the physiotherapy program and the researchers who will perform the statistical analysis will also be blinded to the randomization.
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, three months after surgery
Method of measurement
Questionnaire (VAS)

2

Description
Determination of ankle function
Timepoint
The first visit, three months after surgery
Method of measurement
Questionnaire (AOFAS)

3

Description
Determine the ankle total range of motion (total ROM)
Timepoint
The first visit, three months 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 in the first, second, and sixth weeks after surgery, then centrifuged and converted to 5 ccs PRP. The first PRP solution will be injected into the site of lateral ligament surgery under ultrasound guide by a physician. The second and third injections will be also injected into the tibiotalar joint by the same physician under ultrasound guide.
Category
Treatment - Other

2

Description
Control group: This group receives only routine treatment after surgery.
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
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