Article
Effectiveness and safety of INNORYOS 2.2% in patients with knee osteoarthritis – a prospective non-interventional open clinical trial
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Authors
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Wolfgang Kemmler
- Friedrich-Alexander-Universität Erlangen, Institut für Medizinische Physik, Erlangen, Germany
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Jörg Nürnberger
- Praxis Allgemeine Orthopädie und Unfallchirurgie, Oettingen in Bayern, Germany
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Lola Hofweber
- Institut für Radiologie, Universitätsklinikum Erlangen, 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: INNORYOS is a viscoelastic medical product for the treatment of joint osteoarthritis (OA). The present study aimed to determine the effectiveness and safety of INNORYOS 2.2% on knee pain, stiffness and function in people with knee OA. Primary hypothesis was that the average effect of INNORYOS 2.2% on total Western Ontario and McMaster Universities OA Index (WOMAC) is not inferior to an established standard agent. Further, side effects were monitored throughout the study period.
Methods: Methods: This 26-week prospective non-interventional open clinical trial tested on non-inferiority of INNORYOS 2.2% with an established product (Table 1 ). The ethics committee of the Bayerische Landesärztekammer approved the trial (ID: 21052) that fully complies with the Helsinki Declaration.
Briefly, the following inclusion criteria were applied: (a) primary knee joint OA, (b) age 40 to 85 years, (d) Kellgren-Lawrence grade I to III. Core Exclusion criteria applied were (a) acute inflammation of the affected joint (b) previous trauma/surgery (c) viscosupplement treatment/(d) steroidal injection of the affected joint in the last three months. According to the sample size calculation, 90 eligible persons (54 women, 36 men), each 45 in the INNORYOS and the control group were included.
Both, the study and the control group were provided with a hyaluronic-acid agent (INNORYOS 2.2% vs. Synvisc 0.8%, 2.0 ml) injected in their osteoarthritic knee at baseline and after 1 and 2 weeks respectively (Table 1 [Tab. 1]).
We applied the Intention-to-treat principle. We used 1-tailed-tests, significance was accepted at p<0.05. ANCOVA that adjusted for baseline differences was applied to determine between group differences (i.e. “effects”) after 26 weeks.
Results and conclusion: None of the 90 participants (65.0±10.5 years, BMI: 30.2±5.5 kg/m2) quitted the study or was lost to follow-up. In summary, no inferiority of INNORYOS 2.2% versus control treatment was determined for total WOMAC (p=.29). In detail, WOMAC subcategories “pain” (p=.26), “function” (p=.49) and “stiffness” (p=.009) consistently revealed more favorable data after INNORYOS 2.2% treatment compared with the established product. No adverse effects were observed or reported by the participants. Further no changes of co-medication or other confounders with impact on the study outcomes addressed here were observed.
INNORYOS 2.2% revealed more favorable effect on all WOMAC categories compared with an established product. Thus, the present study provided further evidence for the effectiveness and safety of INNORYOS 2.2% in patients with early to advanced knee OA.
