title: Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing Phase IV study.
abstract: OBJECTIVE
  The primary objective of this study was to evaluate the efficacy, safety, and duration of action of viscosupplementation with Crespine® Gel over a 9-month period.
  
  
  METHODS
  The study was a post-marketing Phase IV study. A total of 109 participants with osteoarthritis of the knee (grades 1-4) in the tibio-femoral compartment were recruited in Jordan. Data were collected from each participant during the baseline visit. Each participant received Crespine® Gel injection, and follow-up visits took place at 3 months, 6 months, and 9 months post-injection.
  
  
  METHODS
  An assessment of participants by phone was conducted at 1 month, 2 months, 4 months, 5 months, 7 months, and 8 months post-injection. Western Ontario and McMaster Universities Arthritis Index questionnaires were completed during each visit. A 72-hour visit questionnaire was used to assess the safety of the injection. Statistical analysis included a two-sided 95% confidence interval for the difference between pain scores across visits, and the percent change from baseline was calculated.
  
  
  RESULTS
  The full analysis included 84 participants who gave their informed consent and finished the necessary baseline and follow-up visits needed to assess efficacy and safety. Peak improvement was noted at 5 months post-injection, when pain and physical performance scores had decreased to 2.60 and 9.90, respectively, and the stiffness score was 0.33. The peak improvement in stiffness was noted at 8 months post-injection, when the stiffness score had decreased to 0.32. Significant improvements were still apparent at 9 months post-injection, when the pain score was 3.36, the stiffness score was 0.42, and the physical performance score was 11.5. All side effects were local and transient, and included pain, swelling, and redness of the knee. Most side effects were treated.
  
  
  CONCLUSIONS
  Hyaluronan should be encouraged as an alternative or adjunct treatment to oral analgesics to reduce their required doses, and delay potential future surgical intervention.
authors.affiliation: Department of Orthopedics Surgery, King Abdullah University Hospital, Jordan University of Science and Technology, Irbid, Jordan.
authors.forename: Khaldoon
authors.initials: K
authors.lastname: Bashaireh
authors.affiliation: Private Clinic, Amman, Jordan.
authors.forename: Ziad
authors.initials: Z
authors.lastname: Naser
authors.affiliation: Private Clinic, Amman, Jordan.
authors.forename: Khaled Al
authors.initials: KA
authors.lastname: Hawadya
authors.affiliation: Private Clinic, Amman, Jordan.
authors.forename: Sorour
authors.initials: S
authors.lastname: Sorour
authors.affiliation: Elaf Medical Supplies Company, Amman, Jordan.
authors.forename: Rami Nabeel
authors.initials: RN
authors.lastname: Al-Khateeb
mesh_terms: D003432:Cross-Linking Reagents / Q000737:chemistry*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000009:adverse effects* / Q000737:chemistry / Q000627:therapeutic use*; D007267:Injections; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000188:drug therapy*; D061214:Patient Safety; D011358:Product Surveillance, Postmarketing
chemical_list: D003432:Cross-Linking Reagents; D006820:Hyaluronic Acid
keywords: Crespine® Gel; hyaluronic acid; intra-articular injection; osteoarthritis