Intra-operative Injection of Autologous Conditioned Plasma (ACP) Following Partial Meniscectomy

Study Overview
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Brief Summary
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The aim of the present double blind controlled study is to evaluate the effects in terms of pain control and functional recovery provided by a single intra-operative injection of ACP performed at the end of arthroscopic partial meniscectomy. Patients included in this trial will be randomized in two treatment groups: the first one will receive a single injection of 3-5 cc of ACP (using a dedicated centrifuge) at the end of the arthroscopic meniscectomy, whereas the second group will be treated by surgery alone. In order to ensure the double blinding of the trial all the patients enrolled will undergo blood harvesting before anesthesia, and acp will be produced just for the patients included in ACP group. All patients will be evaluated basally, and then at 15, 30, 60, and 180 days after surgery by the following evaluation tools: IKDC (International Knee Documentation Committee) subjective, VAS (Visual Analogue Score) for pain, EQ-VAS for general Health Status, KOOS (Knee Injury and Osteoarthritis Outcome Score) and Tegner score. Furthermore, during the basal evaluation and at each follow-up visit up to 2 months, active and passive Range of Motion (ROM) of both the operated and contralateral knee were documented; also in addition, the trans-patellar circumference of both knees was registered to assess the trend of knee swelling over time. Drugs assumption during the follow-up period will be recorded for each patient. All eventual adverse events occurred during the follow-up period will be registered.

Official Title
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Intra-operative ACP Injection Following Partial Meniscectomy: a Randomized Controlled Trial

Conditions
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Meniscectomy

Intervention / Treatment
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* Biological: ACP
* Other: Standard Meniscectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic symptomatic meniscal tears requiring partial resection; healthy contra-lateral knee (i.e. no pain or functional limitation in the contra-lateral joint); Exclusion Criteria: meniscal lesions requiring suture; previous surgery on the index knee; other concurrent articular lesion requiring surgical treatment (e.g.: cartilage or ligament injuries); history of knee infectious arthritis; concurrent rheumatic, metabolic or severe systemic disease; Body Mass Index (BMI) > 30; known hypersensibility or allergy to/towards HA ; alcohol or other substances abuse/excess.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACP GROUP<br>Patients will receive a single intra-op ACP injection following a procedure of arthroscopic partial meniscectomy (medial or lateral) | Biological: ACP<br>* Autologous Conditioned Plasma will be obtained directly in the operatory room from the peripheral venous blood of the patient, and injected intra-articularly at the end of arthroscopic meniscectomy<br>|
| Other: CONTROL GROUP<br>Patients will be treated by standard meniscectomy alone (medial or lateral) | Other: Standard Meniscectomy<br>* Patients will receive standard arthroscopic meniscectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in IKDC (International Knee Documentation Committee) score over the various follow-up times |  | basal, 15,30,60,180 days | 
| Change in VAS( Visual Analogue score) for pain over the various follow-up times |  | basal, 15,30,60,180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) over the various follow-up times |  | basal, 15,30,60,180 days | 
| Change in Tegner Score over the various follow-up times |  | basal, 30,60,180 days | 
| Change in transpatellar circumference over time |  | basal, 15,30,60,180 days | 
| Change in active and passive ROM |  | basal, 15,30,60,180 days | 
| Adverse events report |  | 15 days after surgery | 
| Adverse events report |  | 30 days after surgery | 
| Adverse events report |  | 60 days after surgery | 
| Adverse events report |  | 180 days after surgery | 
| Change in VAS for general health status |  | basal, 30,60,180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autologous Conditioned Plasma, meniscectomy, randomized controlled trial, intra-op injection