Innoryos clinical performance evaluation 2.2 %
- Conditions
- M17.1Other primary gonarthrosis
- Registration Number
- DRKS00027977
- Lead Sponsor
- ALBOMED GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
Patients who meet the American College of Rheumatology clinical criteria for joint osteoarthritis and are deemed appropriate for viscosupplementation by the investigator.
- Primary joint osteoarthritis
- Age between 40 and 85 years
- Kellgren-Lawrence grade (KL) I to III on standing anteroposterior view
- Participation in another clinical trial during or immediately before or after the trial period
- Skin burning and/or significant effusion at one of the knee joints
- Inflammation of the affected joint
- Prior trauma or surgery to the affected knee joint
- Septic or aseptic arthritis
- Viscosupplement treatment on the affected knee within the last 6 months
- Injection with steroidal preparations at the affected knee within the last 3 months
- Known hypersensitivity to hyaluronic acid or other product ingredients
- Known autoimmune disease or abnormal physiological condition
- Skin irritation or infection at the injection site
- Congenital or drug-induced blood clotting disorders, for example due to hemophilia or due to use of anticoagulants such as Marcumar (phenprocoumon) or warfarin
- Pregnancy or breastfeeding
- The patient is not capable of giving consent
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The average performance within the study group is not inferior to the average performance within the comparison group
- Secondary Outcome Measures
Name Time Method - Average improvement of at least 50% on the WOMAC A, B and C scales at the last control appointment compared to the scores recorded at the first treatment appointment.<br>- Positive treatment results** in at least 75% of participants at the last follow-up appointment compared to scores recorded at the first treatment appointment<br>- Positive treatment results** on the WOMAC A scale two weeks after the first injection.<br>- Monitoring of comedication dosage during the monitoring period<br>- Monitoring of any adverse events that occur during the monitoring period