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

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ClinicalTrials.gov Identifier: NCT02629380
Recruitment Status : Completed
First Posted : December 14, 2015
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Federica Balboni, Istituto Ortopedico Rizzoli

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Meniscus Lesion Biological: hyaluronic acid Procedure: meniscectomy alone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Viscosupplementation After Partial Meniscectomy: a Double Blind, Placebo Controlled Randomized Trial
Study Start Date : December 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

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Arms and Interventions
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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
meniscectomy alone
Arthroscopic meniscectomy alone
 Procedure: meniscectomy alone
The patients randomized in this group will receive arthroscopic meniscectomy alone


Outcome Measures
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Primary Outcome Measures :
  1. Change in IKDC (International Knee Documentation Committee) score [ Time Frame: basal, 15,30,60,180 days ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02629380


Locations
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Italy
II Orthopaedic Clinic, Rizzoli Orthopaedic Institute
Bologna, Emilia Romagna, Italy, 40136
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
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Principal Investigator: Elizaveta Kon, MD II Clinic and Nano-biotechnology Lab, Rizzoli Orthopedic Institute, Bologna, Italy
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Federica Balboni, BScD, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT02629380    
Other Study ID Numbers: Rizzoli HA-MEN
First Posted: December 14, 2015    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Federica Balboni, Istituto Ortopedico Rizzoli:
meniscectomy
hyaluronic acid
intra-op injection
randomized controlled trial
placebo
Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
 Physiological Effects of Drugs
Viscosupplements
Protective Agents