title: A double blind randomized active-controlled clinical trial on the intra-articular use of Md-Knee versus sodium hyaluronate in patients with knee osteoarthritis ("Joint").
abstract: BACKGROUND
  To evaluate the clinical outcomes of a group of patients affected by knee osteoarthritis (OA) treated with MD-Knee (Guna S.p.a., Milan, Italy) versus a group of patients treated with sodium hyaluronate.
  
  
  METHODS
  This non-inferiority prospective randomized controlled trial involved 60 patients affected by knee OA, grade 2-3 of Kellgren-Lawrence scale. The MD-Knee Group, Group A (n = 29) was administered five intra-articular injections at 1 week interval; the sodium hyaluronate Group, Group B (n = 31), was administered five doses of intra-articular injection of sodium hyaluronate at 1 week interval. All patients were prospectively evaluated before and at 3 and 6 months after the treatment by the Lequesne Knee Index (LKI) as primary endpoint and the Visual Analogue Scale (VAS), Pain Killer consumption and SF-36 questionnaires as secondary endpoints.
  
  
  RESULTS
  At the 3- and 6 month follow-up, LKI and VAS improved significantly in both groups compared to baseline and no statistically significant differences were observed between Group A and Group B. There was no statistically significant difference in the SF36 questionnaire score and pain killer consumption between two groups at any time point.
  
  
  CONCLUSIONS
  This study shows that both preparations exert similar clinical effects as assessed through multiple outcome measures. MD-Knee is effective on knee OA symptoms over 6 months after a 5-weekly injection course, and it is equally effective as the reference sodium hyaluronate.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  ISRCTN93862496 . Registration date: January 18th, 2016.
authors.affiliation: Department of Internal Medicine, "Regina Apostolorum" Hospital, Via S. Francesco 50, Albano Laziale, Rome, Italy.
authors.forename: Luis Severino
authors.initials: LS
authors.lastname: Martin Martin
authors.affiliation: Operative Unit of Rheumatology "S.Pietro-Fatebenefratelli" Hospital, Via Cassia 600, 00189, Rome, Italy.
authors.forename: Umberto
authors.initials: U
authors.lastname: Massafra
authors.affiliation: Operative Unit of Rheumatology "S.Pietro-Fatebenefratelli" Hospital, Via Cassia 600, 00189, Rome, Italy. bizzi.emanuele@gmail.com.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Bizzi
authors.affiliation: Operative Unit of Rheumatology "S.Pietro-Fatebenefratelli" Hospital, Via Cassia 600, 00189, Rome, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Migliore
mesh_terms: D000368:Aged; D000818:Animals; D003094:Collagen / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D007270:Injections, Intra-Articular; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000175:diagnosis* / Q000188:drug therapy*; D011446:Prospective Studies; D013552:Swine
chemical_list: D006820:Hyaluronic Acid; D003094:Collagen