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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
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
Patients will receive standard arthroscopic meniscectomy
Rizzoli Orthopaedic Institute
Bologna, Italy
Change in IKDC (International Knee Documentation Committee) score over the various follow-up times
Time frame: basal, 15,30,60,180 days
Change in VAS( Visual Analogue score) for pain over the various follow-up times
Time frame: basal, 15,30,60,180 days
Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) over the various follow-up times
Time frame: basal, 15,30,60,180 days
Change in Tegner Score over the various follow-up times
Time frame: basal, 30,60,180 days
Change in transpatellar circumference over time
Time frame: basal, 15,30,60,180 days
Change in active and passive ROM
Time frame: basal, 15,30,60,180 days
Adverse events report
Time frame: 15 days after surgery
Adverse events report
Time frame: 30 days after surgery
Adverse events report
Time frame: 60 days after surgery
Adverse events report
Time frame: 180 days after surgery
Change in VAS for general health status
Time frame: basal, 30,60,180 days
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