title: A new hydrogel for the conservative treatment of meniscal lesions: a randomized controlled study.
abstract: OBJECTIVE
  this study aimed to investigate the efficacy of intra-articular (IA) administration of a hydrogel formulation obtained from a hyaluronic acid (HA) derivative (HYADD4(®)) in the management of meniscal tears and in meniscal tear repair.
  
  
  METHODS
  fifty subjects with degenerative meniscal tears were enrolled into this single-site, observer-blind, parallel-group study. Clinical evaluations were performed at baseline and after 14, 30 and 60 days. Clinical outcomes included: pain reduction (Visual Analog Scale), improvement of knee functionality (WOMAC questionnaire), reduction in length and depth of the meniscal lesion (MRI-confirmed) and SF-36 questionnaire scores. Local tolerability and safety were also investigated.
  
  
  RESULTS
  a significant reduction in VAS pain (p< 0.001) in favor of HYADD4(®) was recorded at day 14 and maintained at all the follow-up assessments. Data on knee functionality were in line with the VAS pain assessment results. A significant reduction in length and depth of the meniscal lesion, assessed using MRI, was found in the HYADD4(®) group compared to the control group (p<0.001).
  
  
  CONCLUSIONS
  the results of this study may indicate a new treatment option in the conservative management of patients complaining of pain due to meniscal tears. The MRI data suggest that the hydrogel formulation of HA used in this study may also play a role in the healing process of the lesion.
  
  
  METHODS
  Level I, prospective randomized clinical trial.
authors.affiliation: Department of Orthopaedics, Sacro Cuore Hospital of Negrar, Negrar (VR), Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Zorzi
authors.affiliation: Department of Orthopaedics, Sacro Cuore Hospital of Negrar, Negrar (VR), Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Rigotti
authors.affiliation: Department of Orthopaedics, Sacro Cuore Hospital of Negrar, Negrar (VR), Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Screpis
authors.affiliation: Department of Clinical Operations, Fidia Farmaceutici SpA, Abano Terme (PD), Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Giordan
authors.affiliation: Department of Orthopaedics, Sacro Cuore Hospital of Negrar, Negrar (VR), Italy.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Piovan
keywords: healing; hyaluronic acid; magnetic resonance; meniscal tear