Article
Assessment of the clinical performance of KD intra-articular Gel 1.0% on knee osteoarthritis. A prospective, non-interventional open label clinical study
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Authors
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Wolfgang Kemmler
- Institut für Radiologie, Universitätsklinikum Erlangen, Institut für Medizinische Physik, Universität Erlangen-Nürnberg, Erlangen, Germany
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Simon von Stengel
- Institut für Radiologie, Universitätsklinikum Erlangen, Erlangen, Germany
| Published: | October 21, 2024 |
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Outline
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Objectives: KD intra-articular Gel (ALBOMED, Germany) is a line of innovative viscoelastic medical product used for the treatment of degenerative joint diseases – particularly in the area of joint osteoarthritis. The present clinical trial aimed to determine the performance of KD intra-articular Gel 1.0%, 2.0 ml on parameters related to knee OA and safety to update the benefit-risk ratio of this product.
Methods: The present prospective non-interventional open label clinical study was conducted over 28 weeks (Table 1 [Tab. 1]). The ethics committee of the Landesärztekammer Thüringen approved the trial (70453/2021/17) that fully complies with the Helsinki Declaration.
Briefly, patients with primary knee OA, 40 and 85 years old were eligible. In summary, 52 eligible persons (26 women, 26 men) participate in this single arm study. The study group was provided with KD intra-articular Gel 1.0% 2.0 ml injected in the osteoarthritic knee joint at baseline and after 1, 2, 3 and 4 weeks (Table 1 [Tab. 1]).
Primary study outcome was: (1) Average improvement of at least 40% inWestern Ontarion and McMasters University OA Index (WOMAC) A (“pain”) score after 28 weeks vs. baseline (Table 1 [Tab. 1]). Secondary study outcomes were (2a) average improvement of at least 40% in WOMAC B (“stiffness”) and C (“function”) score after 28 weeks. (2b) Positive results in total WOMACafter 28 weeks in at least 75% of participants. (2c) Positive WOMAC A development 2 weeks after the first injection. (2d) Monitoring of adverse events during in study period. Wilcoxon rank tests were applied to determine significant changes between baseline and 28 week FU. Significance was accepted at p<.05. Results were listed as mean value±standard deviation.
Results and conclusion: None of the 52 participants (66.2±9.2 years, BMI: 30.0±7.0 kg/m2) quit the study or was lost to follow-up (FU). In summary, the (WOMAC) A (“pain”) score improved from baseline to 28 weeks by 51.0±50.5% (p<.001), thus the primary objective of an improvement of ≥40% was confirmed. In parallel, WOMAC B (“stiffness”) and C (“function”) significantly (p<.001) improved by 59.7±50.5% and 57.4±46.5%. Total WOMAC Score improved in 87.2% of the participants (expectation ≥ 75%). A positive developments two weeks after the first injection were observed in 86.5% of the cohort. Finally no adverse effects were observed or reported by the participants.
In summary, the study revealed consistently positive results in line with our expectations. Thus, this prospective trial provided further evidence for the effectiveness and safety of KD intra-articular Gel 1.0% 2.0 ml in patients with knee osteoarthritis.
