to evaluate the effect of Platelet Rich Plasma (PRP) on post-op patient improvement and tissue healing
Design
this study is done on patients who underwent arthroscopic surgery. the patients were split into PRP and control groups using a random number generator. the PRP group received 2 doses of PRP and both groups were evaluated using scoring systems.
Settings and conduct
this study is done in the shohada-e-tajrish hospital in Tehran, Iran.
Participants/Inclusion and exclusion criteria
inclusion:
patients undergoing arthroscopic surgery of talus
patients over 18 years old
exclusion:
patients who did not consent to the study
patients with previous ankle surgery history
patients with previous ankle fracture history
patients with foot and ankle deformities
patients who underwent other modalities such as mosaicplasty or grafting
coagulopathy patients
patients using anticoagulants
patients who exited the study and did not want to continue
Intervention groups
in the PRP arm, after 1 week of surgery 2 doses of PRP was injected with an interval of 1 week. the 22 gauge needle was injected medial to anterior tibialis through the joint line into the joint space and PRP was injected.
the control group underwent the surgery alone and were followed up
Main outcome variables
patients were evaluated using AOFAS and VAS scoring systems
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230227057547N1
Registration date:2023-05-12, 1402/02/22
Registration timing:retrospective
Last update:2023-05-12, 1402/02/22
Update count:0
Registration date
2023-05-12, 1402/02/22
Registrant information
Name
Hamed Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2268 9199
Email address
masaro1982@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
2020-03-20, 1399/01/01
Actual recruitment end date
2021-03-21, 1400/01/01
Trial completion date
empty
Scientific title
Evaluation of the effect of platelet rich plasma on outcomes after arthroscopic microfracture surgery in osteochondral lesions of talus
Public title
effect of post surgery platelet rich plasma on osteochondral lesions of talus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients undergoing arthroscopic surgery for osteochondral talus lesions
patients older than 18 years
Exclusion criteria:
patients who did not consent
patients with previous ankle surgery
patients with previous ankle fracture
patients with foot deformities
patients using other treatments (graft etc)
coagulopathy patients
patients using anticoagulants
patients who left the study or did not continue
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
we used a random number generator software to randomly assign the patients into two groups of PRP and control while taking into consideration the demographic features and the VAS and AOFAS scores.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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
shahid beheshti university of medical sciences, koodakyar street, velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-03-21, 1401/01/01
Ethics committee reference number
IR.SBMU.MSP.REC.1401.377
Health conditions studied
1
Description of health condition studied
osteochondral lesion of the talus
ICD-10 code
M93.9
ICD-10 code description
Osteochondropathy, unspecified
Primary outcomes
1
Description
AOFAS score
Timepoint
12 months after injection
Method of measurement
history and physical examination
2
Description
VAS (Visual Analog Scale) score
Timepoint
12 months after injection
Method of measurement
history and physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: after surgery the patient receives two injections of PRP
Category
Treatment - Drugs
2
Description
Control group: only undergo surgery/ no placebo given/ no prp injection recieved
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
anonymized patient data will be made available, age and sex data will also be available
When the data will become available and for how long
the data will become available 1 year after publication of results
To whom data/document is available
the data will be only available to people working in academic institutions
Under which criteria data/document could be used
any analysis or use of the data for research purposes is only allowed with written permission from the orthopedics department of shohada e tajrish hopistal
From where data/document is obtainable
shohada e tajrish hospital, tajrish square, tehran , Iran
Dr. Amir Sabaghzade Irani (orthopedics professor)
What processes are involved for a request to access data/document
one should contact Dr. Sabaghzadeh and seek permission to be able to obtain data from the documentary of shohada e tajrish hospital and shahid beheshti university of medical sciences if neccessary