CC BY-NC-ND-license · Joints 2015; 03(03): 116-121
DOI: 10.11138/jts/2015.3.3.116
Original Article
Georg Thieme Verlag KG Stuttgart · New York

Intra-articular glenohumeral injections of HYADD®4-G for the treatment of painful shoulder osteoarthritis: a prospective multicenter, open-label trial

Giuseppe Porcellini
1   Unit of Shoulder and Elbow Surgery, D. Cervesi Hospital, Cattolica (RN), AUSL della Romagna Ambito Rimini, Italy
,
Giovanni Merolla
1   Unit of Shoulder and Elbow Surgery, D. Cervesi Hospital, Cattolica (RN), AUSL della Romagna Ambito Rimini, Italy
2   “Marco Simoncelli” Biomechanics Laboratory D. Cervesi Hospital, Cattolica (RN), AUSL della Romagna Ambito Rimini, Italy
,
Nicola Giordan
3   Research and Development Department - Fidia Farmaceutici SpA, Abano Terme (PD), Italy
,
Paolo Paladini
1   Unit of Shoulder and Elbow Surgery, D. Cervesi Hospital, Cattolica (RN), AUSL della Romagna Ambito Rimini, Italy
,
Andrea Burini
3   Research and Development Department - Fidia Farmaceutici SpA, Abano Terme (PD), Italy
,
Eugenio Cesari
4   Unit of Orthopaedics, Istituto Clinico Humanitas, Rozzano (MI), Italy
,
Alessandro Castagna
4   Unit of Orthopaedics, Istituto Clinico Humanitas, Rozzano (MI), Italy
› Author Affiliations
Further Information

Publication History

Publication Date:
15 September 2017 (online)

Abstract

Purpose: numerous experimental and clinical studies in osteoarthritis (OA) have demonstrated that intraarticular (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.

Level of evidence: Level IV, therapeutic case series.