title: Single-arm open-label study of Durolane (NASHA nonanimal hyaluronic acid) for the treatment of osteoarthritis of the thumb.
abstract: BACKGROUND
  Osteoarthritis of the trapeziometacarpal (TMC) joint of the thumb - also known as rhizarthrosis - is painful and has a significant impact on quality of life. Intra-articular injection of hyaluronic acid may potentially meet the need for effective, minimally invasive intervention in patients not responding adequately to initial treatment. We aimed to confirm the safety and effectiveness of viscosupplementation with Durolane (NASHA nonanimal hyaluronic acid) in rhizarthrosis.
  
  
  METHODS
  This was a prospective, single-arm, multicenter, open-label study with a 6-month follow-up period. Eligible patients had Eaton-Littler grade II-III rhizarthrosis in one TMC joint with pain and visual analog scale (VAS) pain score ≥4 (scale: 0-10). A single injection of NASHA was administered to the affected TMC joint. The primary effectiveness variable was change from baseline in VAS pain score.
  
  
  RESULTS
  Thirty-five patients (mean age 60.8 years; 85.7% female) received NASHA and completed the study. The least-squares mean change from baseline in VAS pain score over 6 months was -2.00, a reduction of 27.8% (p<0.001). The reduction in pain exceeded 25% as early as month 1 (26.5%), and gradual improvement was observed throughout the 6-month follow-up period. Secondary effectiveness parameters included QuickDASH (shortened version of Disabilities of the Arm, Shoulder, and Hand [DASH]), Kapandji thumb opposition test, radial abduction, metacarpophalangeal (MCP) joint flexion, and pinch (clamp) strength. Most of these measurements showed statistically significant improvements from baseline over 6 months. Five adverse events (injection site reactions) were reported in four patients (11.4%), and there were no serious or allergic reactions.
  
  
  CONCLUSIONS
  This study suggests that viscosupplementation using NASHA is effective and well tolerated in treating the symptoms of rhizarthrosis.
authors.affiliation: Department of Orthopedic Surgery, Hospital de Sant Joan Despí Moisés Broggi, Barcelona, Spain.
authors.forename: Eloisa
authors.initials: E
authors.lastname: Velasco
authors.affiliation: Department of Anesthesiology, Vall d'Hebron University Hospital, Barcelona, Spain.
authors.forename: Mª Victoria
authors.initials: MV
authors.lastname: Ribera
authors.affiliation: Department of Orthopedics and Traumatology, Parc Taulí University Hospital, Sabadell, Barcelona, Spain.
authors.forename: Joan
authors.initials: J
authors.lastname: Pi
keywords: Durolane; hyaluronic acid; osteoarthritis; pain; rhizarthrosis; viscosupplementation