Early Viscosupplementation After Partial Meniscectomy: a Randomized Controlled Trial (HA-MEN)

September 12, 2017 updated by: Federica Balboni, Istituto Ortopedico Rizzoli

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

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
    • Emilia Romagna
      • Bologna, Emilia Romagna, Italy, 40136
        • II Orthopaedic Clinic, 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 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. chronic symptomatic meniscal tears requiring partial resection;
  2. healthy contra-lateral knee (i.e. no pain or functional limitation in the contra-lateral joint);

Exclusion Criteria:

  1. previous surgery on the index knee;
  2. other concurrent articular lesion requiring surgical treatment (e.g.: cartilage or ligament injuries);
  3. history of knee infectious arthritis;
  4. concurrent rheumatic, metabolic or severe systemic disease;
  5. Body Mass Index (BMI) > 30;
  6. known hypersensibility or allergy to/towards HA ;
  7. 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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hyaluronic acid group
Single injection of 3 ml HA (Hymovis, Fidia Farmaceutici SpA, Padova, Italy) at the end of the arthroscopic meniscectomy
Biological: hyaluronic acid
A single injection of 3 ml hyaluronic acid to be performed under arthroscopic view at the end of meniscectomy
OTHER: meniscectomy alone
Arthroscopic meniscectomy alone
Procedure: meniscectomy alone
The patients randomized in this group will receive arthroscopic meniscectomy alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in IKDC (International Knee Documentation Committee) score
Time Frame: basal, 15,30,60,180 days
basal, 15,30,60,180 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Change in KOOS (Knee Injury and Osteoarthritis Outcome Score)
Time Frame: basal, 15,30,60,180 days
basal, 15,30,60,180 days
Change in Tegner Score
Time Frame: basal, 15,30,60,180 days
basal, 15,30,60,180 days
Change in VAS (Visual Analogue Scale) for pain
Time Frame: basal, 15,30,60,180 days
basal, 15,30,60,180 days
Change in EQ-VAS for general health
Time Frame: basal, 15,30,60,180 days
basal, 15,30,60,180 days
Adverse events report
Time Frame: 15 days
15 days
Adverse events report
Time Frame: 30 days
30 days
Adverse events report
Time Frame: 60 days
60 days

Collaborators and Investigators

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

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Principal Investigator: Elizaveta Kon, MD, II Clinic and Nano-biotechnology Lab, Rizzoli Orthopedic 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

December 1, 2012

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

December 10, 2015

First Posted (ESTIMATE)

December 14, 2015

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rizzoli HA-MEN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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