Platelet-rich Plasma for Meniscus Repair

Study Overview
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Brief Summary
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This study aims to evaluate the effect of platelet-rich plasma (PRP) on meniscus injury by comparing the imaging and clinical outcomes between patients receiving PRP with meniscus repair surgery and those receiving meniscus repair surgery only.

Detailed Description
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Damage to meniscal tissue is challenging for orthopedic surgeons because of the absence of healing at the avascular zone. Additionally, the accelerated degeneration of articular cartilage and increased rate of knee osteoarthritis that can occur following a meniscal injury. Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets and multiple growth factors concentrated at high level. Because activated platelets have the potential to release growth factors, PRP has been clinically used to accelerate wound healing and tissue regeneration in orthopedic and oral surgery. Several in vivo and in vitro studies have reported favorable outcomes of PRP on meniscal repair; however, the clinical results varied between studies.This clinical trial will investigate the effect of PRP on on meniscus injury. Eligible patients will be randomly assigned to receive PRP with meniscus repair surgery or to receive meniscus repair surgery only. The postoperative imaging and clinical outcomes will be compared and analyzed.

Official Title
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Efficacy of Platelet-rich Plasma on Meniscus Repair- a Randomized Controlled Trial

Conditions
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Platelet-Rich Plasma, Knee Injuries, Meniscus Disorder

Intervention / Treatment
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* Other: platelet-rich plasma
* Other: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20 and 60 years With diagnosis of meniscus injury With indications of meniscus repair surgery Exclusion Criteria: Multiple ligaments injury with prior history of knee surgery Cancer patients Pregnancy Patients who will not cooperate with one-year followup

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PRP group<br>30 patients will receive autologous platelet-rich plasma gel during meniscus repair surgery. | Other: platelet-rich plasma<br>* Autologous platelet-rich plasma gel applied during meniscus repair surgery<br>|
| Placebo Comparator: Control group<br>30 patients will receive meniscus repair surgery only. | Other: control<br>* Meniscus repair surgery only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-month postoperative knee function evaluated by IKDC | Knee function is evaluated using International Knee Documentation Committee (IKDC) score. | 3-month postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month postoperative knee function evaluated by IKDC | Knee function is evaluated using International Knee Documentation Committee (IKDC) score. | 6-month postoperative | 
| 12-month postoperative knee function evaluated by IKDC | Knee function is evaluated using International Knee Documentation Committee (IKDC) score. | 12-month postoperative | 
| 3-month postoperative knee pain evaluated by VAS | Pain level is evaluated using visual analogue scale (VAS). | 3-month postoperative | 
| 6-month postoperative knee pain evaluated by VAS | Pain level is evaluated using visual analogue scale (VAS). | 6-month postoperative | 
| 12-month postoperative knee pain evaluated by VAS | Pain level is evaluated using visual analogue scale (VAS). | 12-month postoperative | 
| Percentage of patients with healed meniscus 6-month postoperative | Healing of meniscus is evaluated by MRI | 6-month postoperative | 
| Percentage of patients with healed meniscus 12-month postoperative | Healing of meniscus is evaluated by MRI | 12-month postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet-Rich Plasma, Meniscus, Knee Injuries