title: Intra-articular glenohumeral injections of HYADD®4-G for the treatment of painful shoulder osteoarthritis: a prospective multicenter, open-label trial.
abstract: OBJECTIVE
  numerous experimental and clinical studies in osteoarthritis (OA) have demonstrated that intra-articular (IA) administration of hyaluronic acid can improve the altered rheological properties of the synovial fluid and exert protective and reparative effects on the joint structure. The objective of this study was to evaluate the safety and performance of HYADD®4-G (Hymovis®) in patients with glenohumeral joint OA.
  
  
  METHODS
  forty-one patients with shoulder pain and limited shoulder function resulting from concentric glenohumeral joint OA were enrolled in a multicenter clinical trial. Patients received two HYADD®4-G injections administered one week apart. The main outcome measure was improvement in shoulder pain on movement at six months as assessed through a 100-mm visual analog scale (VAS), range of motion (ROM) values, and Constant-Murley Shoulder Outcome Score (CS).
  
  
  RESULTS
  two IA injections of HYADD®4-G (Hymovis®) significantly decreased pain and improved shoulder function for up to six months from the first injection. The VAS score decreased (from 66.1 mm to 37.7 mm at six months) and improvements were recorded in the total CS and in the ROM values ( rotation decreased from a mean value of 54.2° at baseline to 63.2° at six months and internal rotation from a mean value of 44.0° at baseline to 45.7° at 26 weeks). No serious adverse events occurred.
  
  
  CONCLUSIONS
  the study results demonstrated that two IA injections of HYADD®4-G (Hymovis®) may be a safe and effective treatment option for shoulder pain associated with glenohumeral OA and that the effects of the injections are still present for up to six months after the treatment.
  
  
  METHODS
  Level IV, therapeutic case series.
authors.affiliation: Unit of Shoulder and Elbow Surgery, D. Cervesi Hospital, Cattolica (RN), AUSL della Romagna Ambito Rimini, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Porcellini
authors.affiliation: Unit of Shoulder and Elbow Surgery, D. Cervesi Hospital, Cattolica (RN), AUSL della Romagna Ambito Rimini, Italy; "Marco Simoncelli" Biomechanics Laboratory D. Cervesi Hospital, Cattolica (RN), AUSL della Romagna Ambito Rimini, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Merolla
authors.affiliation: Research and Development Department - Fidia Farmaceutici SpA, Abano Terme (PD), Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Giordan
authors.affiliation: Unit of Shoulder and Elbow Surgery, D. Cervesi Hospital, Cattolica (RN), AUSL della Romagna Ambito Rimini, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Paladini
authors.affiliation: Research and Development Department - Fidia Farmaceutici SpA, Abano Terme (PD), Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Burini
authors.affiliation: Unit of Orthopaedics, Istituto Clinico Humanitas, Rozzano (MI), Italy.
authors.forename: Eugenio
authors.initials: E
authors.lastname: Cesari
authors.affiliation: Unit of Orthopaedics, Istituto Clinico Humanitas, Rozzano (MI), Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Castagna
keywords: hyaluronan; intra-articular injections; osteoarthritis; painful shoulder; shoulder