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Completed

NCT Number: NCT02629380

Early Viscosupplementation After Partial Meniscectomy: a Randomized Controlled Trial

The rational of intra-articular viscosupplementation is based on both the biological and mechanical properties of HA, which exerts positive effects on the modulation of the entire joint environment.

The aim of the present double blind controlled study was to evaluate the effects in terms of pain control and functional recovery provided by a single intra-operative injection of HA performed at the end of arthroscopic partial meniscectomy.

Patients included in this trial were randomized in two treatment groups: the first one received a single injection of HA (Hymovis 24 mg/3ml, Fidia Farmaceutici Spa, Padova, Italy) at the end of the arthroscopic meniscectomy, whereas the second group was treated by surgery alone.

All patients were evaluated basally, 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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

II Orthopaedic Clinic, Rizzoli Orthopaedic Institute

Bologna, Emilia-Romagna, 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

  • 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

Hyaluronic Acid

Biological

A single injection of 3 ml hyaluronic acid to be performed under arthroscopic view at the end of meniscectomy

meniscectomy alone

Procedure

The patients randomized in this group will receive arthroscopic meniscectomy alone

Primary outcomes

  1. Change in IKDC (International Knee Documentation Committee) score

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

Secondary outcomes

  1. Change in KOOS (Knee Injury and Osteoarthritis Outcome Score)

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

  2. Change in Tegner Score

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

  3. Change in VAS (Visual Analogue Scale) for pain

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

  4. Change in EQ-VAS for general health

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

  5. Change in transpatellar circumference over time

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

  6. Change in active and passive ROM

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

  7. Adverse events report

    Time frame: 15 days

  8. Adverse events report

    Time frame: 30 days

  9. Adverse events report

    Time frame: 60 days

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Early Viscosupplementation After Partial Meniscectomy: a Double Blind, Placebo Controlled Randomized Trial

Acronym: HA-MEN

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 14, 2015
Registry last updated
Sep 13, 2017

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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