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Table 3 Current clinical trials using hydrogels as potential therapies for the management of OA (Data from: https://clinicaltrials.gov)

From: Adhesive hydrogels in osteoarthritis: from design to application

Study title

Material

Groups

Participants

Primary outcome

Phase

Status

Identifier

HUPS: hyalgan use in painful shoulder

Sodium hyaluronate

PBS control;

20 mg sodium hyaluronate injection

602

Improvement in shoulder pain on movement compared to the PBS control group

3

Completed

NCT00377624

Intra-articular PVA hydrogel in knee OA

PVA Hydrogel; Hylan G-F20 (Synvisc-One®)

2 ml injection of PVA hydrogel; 6 ml injection of Hylan G-F20 (Synvisc-One®)

43

To test if there are any adverse events at the injection site

N/A

Completed

NCT04693104

Intra-articular polyacrylamide hydrogel in knee OA

Polyacrylamide hydrogel with silver ions “Argiform”

Hydrous biopolymer with silver ions “Argiform”; Saline

144

Change of the total WOMAC score (WOMAC-T) in grade II-III OA patients

N/A

Unknown

NCT03897686

New hydroxyethyl cellulose hydrogel for the treatment of the pain of knee arthrosis

Hydroxyethyl cellulose hydrogel

Hydrogel injection

50

Pain assessment in terms of percentage of pain reduction using a visual analog scale

N/A

Recruiting

NCT04061733

Treatment of knee OA with PAAG-OA (ROSA)

Polyacrylamide hydrogel (PAAG-OA)

Intra-articular injection of 6 ml PAAG-OA; Intra-articular injection of 6 ml Synvisc-One® (HA)

238

Comparing one injection of PAAG-OA with one injection of Synvisc-One® on pain over 6 months in subjects with knee OA

N/A

Active, not recruiting

NCT04045431

Safety and effectiveness study of a non-crosslinked HA Alkylamide HYADD(TM) 4 hydrogel for OA of the knee

Non-crosslinked HA Alkylamide

HYADD (TM) 4 hydrogel intra-articular injection; Placebo intra- articular injection

332

WOMAC pain sub-score

N/A

Unknown

NCT02187549

Hymovis™ versus placebo in knee OA (Hymovis)

Non-crosslinked HA Alkylamide (Hymovis)

Hymovis intra-articular injection;

Phosphate buffered saline injection

800

WOMAC pain sub-score

3

Completed

NCT01372475

PAAG-OA treatment for knee OA (IDA)

Polyacrylamide hydrogel

Intra-articular polyacrylamide hydrogel injection

49

WOMAC pain sub-score

N/A

Active, not recruiting

NCT04179552

Arthrosamid injection for OA knee

Crosslinked polyacrylamide (Arthrosamid)

Intra-articular injection of water and crosslinked polyacrylamide

60

Changes in the WOMAC score between baseline (pre-injection) and 6 months and 12 months post-injection

N/A

Not yet recruiting

NCT05086068

Aquamid reconstruction for OA of the knee

Polyacrylamide hydrogel (Aquamid)

Intra-articular injection of 3 ml aquamid reconstruction (AR) to the knee

50

Change from baseline in the pain sub-score of the WOMAC

N/A

Unknown

NCT03067090

Evaluation of the evolution of biological and imaging markers of bone and cartilage degradation in patients with knee OA receiving intra-articular injections of a hyaluronan derivative HYMOVIS®

HYMOVIS (obtained by hydration of the HA-based derivative named HYADD4p5)

Two treatment cycles of two injections of HYMOVIS® at baseline and 6 months

50

Assess the variation of type II collagen-specific biomarkers (Coll2-1, Coll2-1NO2 & CTX-II) after HYMOVIS® treatment versus baseline

N/A

Completed

NCT04293861

Geniculate artery embolization for treatment of OA

Embozene™ Color-Advanced hydrogel microspheres coated with an inorganic perfluorinated polymer used for embolization

Transcatheter arterial embolization using Embozene™

23

Change in knee pain using WOMAC score

N/A

Recruiting

NCT04379700

To look at the characteristics of synovial fluid and cartilage matrix in the osteoarthritic knee after HA injection

EUFLEXXA® is a hyaluronate hydrogel produced from bacteria

EUFLEXXA® intra-articular injection

12

To identify imaging markers for characterizing the biochemical profiles in synovial fluid and cartilage in knee OA 3 months after HA injection

4

Completed

NCT01895959

Efficacy and safety of Hymovis ONE® (32 mg/4 ml) intra-articular injection in active patients with knee overuse syndrome

Hymovis® ONE

Hymovis® ONE (32 mg/4 ml) intra-articular mono injection.

31

The efficacy of Hymovis® ONE (32 mg/4 ml) single intra-articular injection in the management of pain caused by knee OA due to overuse: KOOS questionnaire

N/A

Completed

NCT04661111

  1. Western Ontario and McMaster Universities Arthritis Index (WOMAC) consists of three subscales: pain (five questions, 0–20 points), stiffness (two questions, 0–8 points), and physical function (17 questions, 0–68points). Higher scores represent worse pain, stiffness, and functional limitations. Coll2 type II collagen, Coll2-1NO2 nitrate form of Coll2-1, CTX-II c-terminal crosslinking telopeptide of type-II collagen, OA osteoarthritis, PVA polyvinyl alcohol, KOOS knee injury and osteoarthritis outcome score, N/A not applicable