Protocol summary
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Study aim
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The effect of platelet rich plasma on pain and function in patients with lateral ankle sprain after modified Brostrom surgery
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Design
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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).
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Settings and conduct
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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, three and six months after surgery for both groups.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Ankle pain by VAS; ankle function by AOFAS and total ROM
General information
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Reason for update
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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 3 and 6 months after surgery.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200307046714N1
Registration date:
2022-01-15, 1400/10/25
Registration timing:
prospective
Last update:
2022-09-08, 1401/06/17
Update count:
2
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Registration date
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2022-01-15, 1400/10/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-01-20, 1400/10/30
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Expected recruitment end date
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2022-03-20, 1400/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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The effect of platelet rich plasma in lateral ankle sprain
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
20
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-02-21, 1399/12/03
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1399.1264
Health conditions studied
1
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Description of health condition studied
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lateral ankle sprain
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ICD-10 code
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S93.40
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ICD-10 code description
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Sprain of unspecified ligament of ankle
Primary outcomes
1
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Description
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Determination of ankle pain
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Timepoint
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The first visit, three months after surgery, six months after surgery
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Method of measurement
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Questionnaire (VAS)
2
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Description
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Determination of ankle function
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Timepoint
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The first visit, three months after surgery, six months after surgery
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Method of measurement
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Questionnaire (AOFAS)
3
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Description
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Determine the ankle total range of motion (total ROM)
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Timepoint
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The first visit, three months after surgery, six months after surgery
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Method of measurement
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Manual joiniometry
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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Control group: This group receives only routine treatment after surgery.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available