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

May 9, 2023 updated by: Istituto Ortopedico Rizzoli

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Rizzoli Orthopaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACP GROUP
Patients will receive a single intra-op ACP injection following a procedure of arthroscopic partial meniscectomy (medial or lateral)
Biological: ACP
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
Other: CONTROL GROUP
Patients will be treated by standard meniscectomy alone (medial or lateral)
Other: Standard Meniscectomy
Patients will receive standard arthroscopic meniscectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in IKDC (International Knee Documentation Committee) score over the various follow-up times
Time Frame: basal, 15,30,60,180 days
basal, 15,30,60,180 days
Change in VAS( Visual Analogue score) for pain over the various follow-up times
Time Frame: basal, 15,30,60,180 days
basal, 15,30,60,180 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Study Director: Alessandro Di Martino, MD, Nano-biotechnology Lab, Rizzoli Orthopaedic Institute, Bologna, Italy
  • Principal Investigator: Giuseppe Filardo, MD, Biomechanics Lab, Rizzoli Orthopaedic Institute, Bologna, Italy
  • Study Chair: Berardo Di Matteo, MD, Biomechanics Lab, Rizzoli Orthopaedic Institute, Bologna, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2017

Primary Completion (Actual)

August 11, 2017

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ACP-MEN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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