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

Giuseppe Porcellini, Giovanni Merolla, Nicola Giordan, Paolo Paladini, Andrea Burini, Eugenio Cesari, Alessandro Castagna

Research output: Contribution to journalArticle

7 Citations (Scopus)

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 (Hy - movis®) 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.

Original languageEnglish
Pages (from-to)116-121
Number of pages6
JournalJoints
Volume3
Issue number3
DOIs
Publication statusPublished - Jul 1 2015

Fingerprint

Intra-Articular Injections
Shoulder Pain
Osteoarthritis
Injections
Shoulder Joint
Synovial Fluid
Hyaluronic Acid
Therapeutics
Articular Range of Motion
Visual Analog Scale
Multicenter Studies
Joints
Outcome Assessment (Health Care)
Clinical Trials
Safety

Keywords

  • Hyaluronan
  • Intra-articular injections
  • Osteoarthritis
  • Painful shoulder
  • Shoulder

ASJC Scopus subject areas

  • Orthopedics and Sports Medicine
  • Rehabilitation
  • Surgery

Cite this

Intra-articular glenohumeral injections of HYADD®4-G for the treatment of painful shoulder osteoarthritis : A prospective multicenter, open-label trial. / Porcellini, Giuseppe; Merolla, Giovanni; Giordan, Nicola; Paladini, Paolo; Burini, Andrea; Cesari, Eugenio; Castagna, Alessandro.

In: Joints, Vol. 3, No. 3, 01.07.2015, p. 116-121.

Research output: Contribution to journalArticle

Porcellini, Giuseppe ; Merolla, Giovanni ; Giordan, Nicola ; Paladini, Paolo ; Burini, Andrea ; Cesari, Eugenio ; Castagna, Alessandro. / Intra-articular glenohumeral injections of HYADD®4-G for the treatment of painful shoulder osteoarthritis : A prospective multicenter, open-label trial. In: Joints. 2015 ; Vol. 3, No. 3. pp. 116-121.
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T2 - A prospective multicenter, open-label trial

AU - Porcellini, Giuseppe

AU - Merolla, Giovanni

AU - Giordan, Nicola

AU - Paladini, Paolo

AU - Burini, Andrea

AU - Cesari, Eugenio

AU - Castagna, Alessandro

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N2 - 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 (Hy - movis®) 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.

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