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Completed

NCT Number: NCT02872753

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACP

Biological

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

Standard Meniscectomy

Other

Patients will receive standard arthroscopic meniscectomy

Primary outcomes

  1. Change in IKDC (International Knee Documentation Committee) score over the various follow-up times

    Time frame: basal, 15,30,60,180 days

  2. Change in VAS( Visual Analogue score) for pain over the various follow-up times

    Time frame: basal, 15,30,60,180 days

Secondary outcomes

  1. Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) over the various follow-up times

    Time frame: basal, 15,30,60,180 days

  2. Change in Tegner Score over the various follow-up times

    Time frame: basal, 30,60,180 days

  3. Change in transpatellar circumference over time

    Time frame: basal, 15,30,60,180 days

  4. Change in active and passive ROM

    Time frame: basal, 15,30,60,180 days

  5. Adverse events report

    Time frame: 15 days after surgery

  6. Adverse events report

    Time frame: 30 days after surgery

  7. Adverse events report

    Time frame: 60 days after surgery

  8. Adverse events report

    Time frame: 180 days after surgery

  9. Change in VAS for general health status

    Time frame: basal, 30,60,180 days

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: ACP-MEN

Important dates

Study start
2017
Primary completion
2017
Study completion
2023
First posted
Aug 19, 2016
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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