Prospective Analysis of Introperative RegenLab PRP and Hyaluronic Acid in Patients With Knee ACL Tear

Study Overview
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Brief Summary
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Purpose: The purpose of this article is to examine the clinical application of PRP and PRP+hyaluronic acid in disorders in the knee. Methods: The study was conducted on 150 adult patients with age over 20 years old affected by unilateral ACL complete tear and receiving ACL reconstruction. We divided the patients in three groups, and we treated the group A with perioperative injection of HHA, group B with perioperative HHA+PRP, group C with perioperative normal saline. Follow-up: Every 1,3,and 12months, we recheck physical exmianation at OPD and recheck MRI at postoperative 3 months.

Official Title
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Prospective Analysis of Introperative RegenLab PRP and Hyaluronic Acid in Patients With Knee ACL Tear

Conditions
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PRP, ACL, Hyaluronic Acid

Intervention / Treatment
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* Combination Product: RegenLab PRP
* Combination Product: hyaluronic acid
* Other: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: receiving unilateral ACL reconstruction in our hospital postoperative follow-up over 3 month Exclusion Criteria: postoperative follow-up less than 3 month possible pregnency with coagulation disease NSAIDs intake during study period

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Experimental: Experimental group 1<br>Intraoperative1 kit of Platelet-rich plasma(PRP) injection into knee joint after anterior cruciate ligament (ACL) reconstruction. | Combination Product: RegenLab PRP<br>* PRP preparations also improved functional outcome scores compared to hyaluronic acid and placebo in patients affected by knee osteoarthritis (OA). Based on previous studys, we can conclude that the PRP treatment is a safe and efficacious procedure which can provide functional benefit.<br>|
| Experimental: Experimental group 2<br>Intraoperative1 kit of PRP+Hyaluronic acid(HA) injection into knee joint after ACL reconstruction. | Combination Product: hyaluronic acid<br>* Few studies investigated the effects of HA+PRP combined treatment for knee osteoarthritis (OA). Numerous studies demonstrated the efficacy of HA injection therapy in knee OA for a clinical point of view, reducing the pain and improving the quality of life.<br>* Other names: RegenLab PRP;|
| Placebo Comparator: Experimental group 3<br>Intraoperative 20 ml normal saline injection into knee joint after ACL reconstruction. | Other: normal saline<br>* In this study, we compare introperative PRP/PRP+HA/normal saline in ACL reconstruction patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test | the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist | postoperative 1 month | 
| 150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test | the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist | postoperative 3 months | 
| 150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test | the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist | postoperative 12 months | 
| 150 of participants with preoperative and postoperative Magnetic Resonance Imaging are accessed | anterior cruciate ligament was accessed by MRI T1 and T2 image; MRI was checked by one orthopedist | postoperative 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRP; ACL reconstruction