NCT02872753: ACP-MEN

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

Completed Phase 4 Last updated 10 May 2023

What this trial tests

Phase 4 trial testing ACP in Meniscectomy in 90 participants. Completed in 31 January 2023.

Timeline

11 July 2017

Primary endpoint
11 August 2017

31 January 2023

Quick facts

Lead sponsor	Istituto Ortopedico Rizzoli
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	90
Start date	11 July 2017
Primary completion	11 August 2017
Estimated completion	31 January 2023
Sites	1 location across Italy

Drugs / interventions tested

• ACP — full drug profile →
• Standard Meniscectomy

Conditions studied

• Meniscectomy — all drugs for Meniscectomy →

Sponsor

Istituto Ortopedico Rizzoli — full company profile →

Who can join

Adults 18 to 55, any sex, with Meniscectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Platelet-Rich Plasma Injections Do Not Improve the Recovery After Arthroscopic Partial Meniscectomy: A Double-Blind Randomized Controlled Trial.
   Lo Presti M, Costa GG, Agrò G, Vasco C, et al · · 2024 · cited 2× · PMID 39425245 · DOI 10.1177/03635465241283052