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

ACP-MEN

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.

2017-07-11

2017-08-11

2023-01-31

Completed

Early phase I

90

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}

2023-05-10