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

Phase 4

Completed

• Conditions: Meniscectomy
• Interventions: Biological: ACP; Other: Standard Meniscectomy

• Registration Number: NCT02872753
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Study Start: 2017-07-11
• Primary Completion: 2017-08-11
• Status Verified: 2022-09
• Study Completion: 2023-01-31
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACP GROUP	ACP	Patients will receive a single intra-op ACP injection following a procedure of arthroscopic partial meniscectomy (medial or lateral)
CONTROL GROUP	Standard Meniscectomy	Patients will be treated by standard meniscectomy alone (medial or lateral)

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Rizzoli Orthopaedic Institute; 🇮🇹 Bologna, Italy