Rizzoli Orthopaedic Institute
Bologna, 40136, Italy
NCT Number: NCT02872753
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 4
Bologna, 40136, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: basal, 15,30,60,180 days
Time frame: basal, 15,30,60,180 days
Time frame: basal, 15,30,60,180 days
Time frame: basal, 30,60,180 days
Time frame: basal, 15,30,60,180 days
Time frame: basal, 15,30,60,180 days
Time frame: 15 days after surgery
Time frame: 30 days after surgery
Time frame: 60 days after surgery
Time frame: 180 days after surgery
Time frame: basal, 30,60,180 days
Istituto Ortopedico Rizzoli
Other
Intra-operative ACP Injection Following Partial Meniscectomy: a Randomized Controlled Trial
Acronym: ACP-MEN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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