Efficacy and Safety of Intra-Articular Cross-Linked Sodium Hyaluronate for the Treatment of Knee Osteoarthritis: A Prospective, Active-Controlled, Randomized, Parallel-Group, Double-Blind, Multicenter Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Patients
2.2. Study Design, Treatments, and Blinding
2.3. Outcome Measures
2.4. Statistical Methods
3. Results
3.1. Patients
3.2. Outcomes
3.2.1. Efficacy
3.2.2. Safety
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Parameter | Test Group (n = 142) | Comparator Group (n = 142) | Overall (n = 284) |
---|---|---|---|
Sex, n (%) | |||
Male | 53 (37.3) | 52 (36.6) | 105 (37) |
Female | 89 (62.7) | 90 (63.4) | 179 (63.0) |
Age (years) | |||
Mean (SD) | 62.7 (9.53) | 62.5 (9.43) | 62.6 (9.47) |
Age-group (years), n (%) | |||
<65 | 76 (53.5) | 78 (54.9) | 154 (54.2) |
≥65 | 66 (46.5) | 64 (45.1) | 130 (45.8) |
Race, n (%) | |||
White | 142 (100) | 142 (100) | 284 (100) |
Country, n (%) | |||
Czech Republic | 41 (28.9) | 38 (26.8) | 79 (27.8) |
Germany | 25 (17.6) | 25 (17.6) | 50 (17.6) |
Poland | 76 (53.5) | 79 (55.6) | 155 (54.6) |
Body mass index (kg/m2) | |||
Mean (SD) | 29.9 (4.28) | 30.2 (4.06) | 30.1 (4.17) |
Kellgren–Lawrence grade of the target knee, n (%) | |||
Grade I | 0 | 0 | 0 |
Grade II | 74 (52.1) | 74 (52.1) | 148 (52.1) |
Grade III | 68 (47.9) | 68 (47.9) | 136 (47.9) |
Grade IV | 0 | 0 | 0 |
Time since OA diagnosis (years) | |||
Mean (SD) | 6.9 (6.07) | 8.0 (6.94) | 7.4 (6.53) |
Side of knee OA at screening, n (%) | |||
Unilateral | 55 (38.7) | 54 (38.0) | 109 (38.4) |
Bilateral | 87 (61.3) | 88 (62.0) | 175 (61.6) |
Responder Rates by OMERACT-OARSI | Test Group (n = 128) n (%) | Comparator Group (n = 128) n (%) |
---|---|---|
Week 13 | 83 (64.8) | 82 (64.1) |
Comparison between groups | ||
95% CI for proportion difference | −0.109, 0.125 | |
χ2 p-value | 0.8961 | |
Week 26 | 74 (57.8) | 78 (60.9) |
Comparison between groups | ||
95% CI for proportion difference | −0.152, 0.089 | |
χ2 p-value | 0.6107 |
Test Group (n = 141) n (%) Events | Comparator Group (n = 141) n (%) Events | |
---|---|---|
TEAEs * | 43 (30.5) 62 | 47 (33.3) 75 |
TEAE severity | ||
Mild | 28 (19.9) 35 | 27 (19.1) 37 |
Moderate | 18 (12.8) 25 | 26 (18.4) 35 |
Severe | 2 (1.4) 2 | 3 (2.1) 3 |
Serious TEAEs | 1 (0.7) 1 | 2 (1.4) 2 |
TEAEs with local reactions | 1 (0.7) 1 | 4 (2.8) 5 |
TEAEs by preferred term † | ||
Arthralgia | 5 (3.5) 6 | 7 (5.0) 7 |
Headache | 5 (3.5) 7 | 4 (2.8) 4 |
ADEs | 5 (3.5) 6 | 8 (5.7) 12 |
ADEs by preferred term | ||
Arthralgia | 2 (1.4) 2 | 3 (2.1) 3 |
Injection site pain | 2 (1.4) 2 | 2 (1.4) 2 |
Joint swelling | 1 (0.7) 1 | 3 (2.1) 3 |
Injection site joint effusion | 0 | 1 (0.7) 2 |
Dermatitis contact | 0 | 1 (0.7) 2 |
Mobility decreased | 1 (0.7) 1 | 0 |
Osteoarthritis | 0 | 1 (0.7) 1 |
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Blicharski, T.; Łukasik, P.; Plebanski, R.; Żęgota, Z.; Szuścik, M.; Moster, E.; Pavelka, K.; Jeon, S.; Park, S.L. Efficacy and Safety of Intra-Articular Cross-Linked Sodium Hyaluronate for the Treatment of Knee Osteoarthritis: A Prospective, Active-Controlled, Randomized, Parallel-Group, Double-Blind, Multicenter Study. J. Clin. Med. 2023, 12, 2982. https://doi.org/10.3390/jcm12082982
Blicharski T, Łukasik P, Plebanski R, Żęgota Z, Szuścik M, Moster E, Pavelka K, Jeon S, Park SL. Efficacy and Safety of Intra-Articular Cross-Linked Sodium Hyaluronate for the Treatment of Knee Osteoarthritis: A Prospective, Active-Controlled, Randomized, Parallel-Group, Double-Blind, Multicenter Study. Journal of Clinical Medicine. 2023; 12(8):2982. https://doi.org/10.3390/jcm12082982
Chicago/Turabian StyleBlicharski, Tomasz, Piotr Łukasik, Rafal Plebanski, Zbigniew Żęgota, Marek Szuścik, Erik Moster, Karel Pavelka, Seonhui Jeon, and So La Park. 2023. "Efficacy and Safety of Intra-Articular Cross-Linked Sodium Hyaluronate for the Treatment of Knee Osteoarthritis: A Prospective, Active-Controlled, Randomized, Parallel-Group, Double-Blind, Multicenter Study" Journal of Clinical Medicine 12, no. 8: 2982. https://doi.org/10.3390/jcm12082982