Clinical trial NCT02872753: Intra-operative Injection of Autologous Conditioned Plasma (ACP) Following Partial Meniscectomy
Official title: Intra-operative ACP Injection Following Partial Meniscectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meniscectomy
Keywords: Autologous Conditioned Plasma
meniscectomy
randomized controlled trial
intra-op injection
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in IKDC (International Knee Documentation Committee) score over the various follow-up times
timeFrame: basal, 15,30,60,180 days
measure: Change in VAS( Visual Analogue score) for pain over the various follow-up times
timeFrame: basal, 15,30,60,180 days
Secondary outcomes:
measure: Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) over the various follow-up times
timeFrame: basal, 15,30,60,180 days
measure: Change in Tegner Score over the various follow-up times
timeFrame: basal, 30,60,180 days
measure: Change in transpatellar circumference over time
timeFrame: basal, 15,30,60,180 days
measure: Change in active and passive ROM
timeFrame: basal, 15,30,60,180 days
measure: Adverse events report
timeFrame: 15 days after surgery
measure: Adverse events report
timeFrame: 30 days after surgery
measure: Adverse events report
timeFrame: 60 days after surgery
measure: Adverse events report
timeFrame: 180 days after surgery
measure: Change in VAS for general health status
timeFrame: basal, 30,60,180 days
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Rizzoli Orthopaedic Institute
Study officials:
affiliation: Nano-biotechnology Lab, Rizzoli Orthopaedic Institute, Bologna, Italy
name: Alessandro Di Martino, MD
role: STUDY_DIRECTOR
affiliation: Biomechanics Lab, Rizzoli Orthopaedic Institute, Bologna, Italy
name: Giuseppe Filardo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Biomechanics Lab, Rizzoli Orthopaedic Institute, Bologna, Italy
name: Berardo Di Matteo, MD
role: STUDY_CHAIR
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