M17.1
Conditions
Interventions
Group 1: The assignment of a certain participant to the study group is made by the treating physician. His decision is based on the individual medical condition of the participant and the experience o
Sponsors
ALBOMED GmbH
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The average performance within the study group is not inferior to the average performance within the comparison group | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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. - Positive treatment results** in at least 75% of participants at the last follow-up appointment compared to scores recorded at the first treatment appointment - Positive treatment results** on the WOMAC A scale two weeks after the first injection. - Monitoring of comedication dosage during the monitoring period - Monitoring of any adverse events that occur during the monitoring period | — |
Countries
Germany
Contacts
Public ContactOleg Repp
ALBOMED GmbH
Outcome results
None listed