title: HYADD 4 versus methylprednisolone acetate in symptomatic knee osteoarthritis: a single-centre single blind prospective randomised controlled clinical study with 1-year follow-up.
abstract: OBJECTIVE
  The aim of the present study was to compare the clinical results and the quality of life in patients with symptomatic knee osteoarthritis randomised to either a new HA (HYADD 4) or corticosteroid (CS). A separate rationale was to evaluate the safety profile of HYADD 4.
  
  
  METHODS
  All the patients presenting for unilateral symptomatic primary knee osteoarthritis were prospectively randomly assigned to receive 2 injections of either HYADD 4 or CS, and were evaluated before the injections and at 6, 12, 26 and 52 weeks. Primary end point was WOMAC score at 26 weeks; secondary end points were WOMAC score, VAS for pain, and SF-36 score at any time point.
  
  
  RESULTS
  There were 53 females and 22 males in the HYADD 4 group (mean age 71.5±10.6 years), and 50 females and 25 males in the CS group (mean age 68.6±9.9 years). The observed sided effects were mild and their incidence was similar in the two groups. Patients in the HYADD 4 group reported significantly better WOMAC scores at 26 weeks. The patients improved in all considered outcomes after the injections, with a peak of therapeutic effect between 6 and 12 weeks. Patients in the HYADD 4 group obtained significantly better scores than the CS group up to 26 weeks. At the 1-year follow-up no statistically significant differences between treatments were detected.
  
  
  CONCLUSIONS
  HYADD 4 did not have significantly higher side effects when compared to CS injections and provided better short-term (but not long-term) control of symptoms in patients with mild to moderate knee osteoarthritis. Patients with less pain and dysfunction at baseline may be the best candidates for HYADD 4 injections.
authors.affiliation: Department of Orthopaedic Surgery, University of Rome Tor Vergata, Italy. s.bisicchia@gmail.com.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Bisicchia
authors.affiliation: Department of Orthopaedic Surgery, University of Rome Tor Vergata, Italy.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Bernardi
authors.affiliation: Department of Orthopaedic Surgery, University of Rome Tor Vergata, Italy.
authors.forename: Cosimo
authors.initials: C
authors.lastname: Tudisco
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004185:Disability Evaluation; D004334:Drug Administration Schedule; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006304:Health Status; D006305:Health Status Indicators; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use*; D007270:Injections, Intra-Articular; D007719:Knee Joint / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077555:Methylprednisolone Acetate; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D010147:Pain Measurement; D011446:Prospective Studies; D011788:Quality of Life; D012074:Remission Induction; D012384:Rome; D012720:Severity of Illness Index; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D005938:Glucocorticoids; C000613592:HYADD 4; D000077555:Methylprednisolone Acetate; D006820:Hyaluronic Acid; D008775:Methylprednisolone