PMID- 38345716
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240310
IS  - 2198-6576 (Print)
IS  - 2198-6584 (Electronic)
IS  - 2198-6576 (Linking)
VI  - 11
IP  - 2
DP  - 2024 Apr
TI  - Safety and Efficacy of Hybrid Cooperative Complexes of Sodium Hyaluronate and 
      Sodium Chondroitin for the Treatment of Patients with Symptomatic Knee 
      Osteoarthritis.
PG  - 381-395
LID - 10.1007/s40744-024-00643-8 [doi]
AB  - INTRODUCTION: Knee osteoarthritis (KOA) represents a widespread degenerative 
      disease that causes pain and motor disability. Conservative treatments mainly 
      focus on relieving symptoms, improving joint function, and trying to delay 
      surgery. Safety and efficacy of hybrid cooperative complexes (2.4% sodium 
      hyaluronate and 1.6% sodium chondroitin; HA-SC) for symptomatic KOA were 
      investigated in a single-arm, prospective, pilot study. METHODS: Patients with a 
      visual analogue scale (VAS) pain score >/= 4 and Kellgren-Lawrence Grade < 4 
      received a single intraarticular HA-SC injection. Patients with a VAS score 
      change from baseline </= 1 received a second injection at day 30. Device-related 
      adverse events (DR-AEs)/adverse events (AEs) were primary endpoints. Secondary 
      endpoints included Western Ontario and McMaster Universities Osteoarthritis Index 
      LK 3.1 (WOMAC LK 3.1), VAS, patient global assessment of disease status (PtGA), 
      and patient proportion needing a second injection. RESULTS: Of 83 patients with 
      KOA (Kellgren-Lawrence Grade, 2-3), 34.9% had DR-AEs at day 7. No serious 
      DR-AEs/AEs were reported. A significant (P < 0.0001) reduction over time in VAS 
      pain score plus WOMAC pain, stiffness, physical function limitation, and total 
      scores was reported. Median PtGA scores indicated a 'slight improvement' at most 
      follow-up visits. Only 18.1% of patients required a second injection. 
      CONCLUSIONS: A single intraarticular HA-SC injection was safe, well-tolerated, 
      and did not lead to major deterioration in terms of reducing knee pain, 
      stiffness, and physical function limitation in patients with symptomatic KOA.
CI  - (c) 2024. The Author(s).
FAU - Sconza, Cristiano
AU  - Sconza C
AUID- ORCID: 0000-0002-5345-9902
AD  - IRCCS Humanitas Research Hospital, via Manzoni 56, Rozzano, 20089, Milan, Italy. 
      cristiano.sconza@humanitas.it.
AD  - Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 
      4, Pieve Emanuele, 20072, Milan, Italy. cristiano.sconza@humanitas.it.
FAU - Romano, Dario
AU  - Romano D
AD  - IRCCS Humanitas Research Hospital, via Manzoni 56, Rozzano, 20089, Milan, Italy.
FAU - Scaturro, Dalila
AU  - Scaturro D
AD  - Department of Surgical, Oncological and Stomatological Disciplines, University of 
      Palermo, Via del Vespro, 129, 90127, Palermo, Italy.
FAU - Mauro, Giulia Letizia
AU  - Mauro GL
AD  - Department of Surgical, Oncological and Stomatological Disciplines, University of 
      Palermo, Via del Vespro, 129, 90127, Palermo, Italy.
FAU - Leonardi, Giulia
AU  - Leonardi G
AD  - Department of Physical and Rehabilitation Medicine, University Hospital "G. 
      Martino", Messina, Italy.
FAU - Alito, Angelo
AU  - Alito A
AD  - Department of Biomedical, Dental Sciences and Morphological and Functional 
      Images, University of Messina, Messina, Italy.
FAU - Respizzi, Stefano
AU  - Respizzi S
AD  - IRCCS Humanitas Research Hospital, via Manzoni 56, Rozzano, 20089, Milan, Italy.
FAU - Kon, Elizaveta
AU  - Kon E
AD  - IRCCS Humanitas Research Hospital, via Manzoni 56, Rozzano, 20089, Milan, Italy.
AD  - Department of Traumatology, Orthopaedics and Disaster Surgery, Sechenov First 
      Moscow State Medical University, 119991, Moscow, Russia.
FAU - Di Matteo, Berardo
AU  - Di Matteo B
AD  - IRCCS Humanitas Research Hospital, via Manzoni 56, Rozzano, 20089, Milan, Italy.
AD  - Department of Traumatology, Orthopaedics and Disaster Surgery, Sechenov First 
      Moscow State Medical University, 119991, Moscow, Russia.
LA  - eng
PT  - Journal Article
DEP - 20240212
PL  - England
TA  - Rheumatol Ther
JT  - Rheumatology and therapy
JID - 101674543
PMC - PMC10920506
OTO - NOTNLM
OT  - Conservative therapy
OT  - Hyaluronic acid
OT  - Injections
OT  - Knee
OT  - Osteoarthritis
OT  - SINOGEL(R)
OT  - Viscosupplementation
COIS- Cristiano Sconza, Dario Romano, Dalila Scaturro, Giulia Letizia Mauro, Giulia 
      Leonardi, Angelo Alito, Stefano Respizzi, Elizaveta Kon, and Berardo Di Matteo 
      declare no conflict of interest.
EDAT- 2024/02/12 15:44
MHDA- 2024/02/12 15:45
PMCR- 2024/02/12
CRDT- 2024/02/12 11:12
PHST- 2023/12/15 00:00 [received]
PHST- 2024/01/18 00:00 [accepted]
PHST- 2024/02/12 15:45 [medline]
PHST- 2024/02/12 15:44 [pubmed]
PHST- 2024/02/12 11:12 [entrez]
PHST- 2024/02/12 00:00 [pmc-release]
AID - 10.1007/s40744-024-00643-8 [pii]
AID - 643 [pii]
AID - 10.1007/s40744-024-00643-8 [doi]
PST - ppublish
SO  - Rheumatol Ther. 2024 Apr;11(2):381-395. doi: 10.1007/s40744-024-00643-8. Epub 
      2024 Feb 12.