M17.0 M17.1 M17.4 M17.5
Conditions
Interventions
Group 1: With the medical device EOT®II, using a special process the investigator prepares cell-free autologous conditioned serum which will be injected intra-articular in knee joint four to six times
Sponsors
ORTHOGEN AG
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Confirmed Knee OA (Kellgren-Lawrence Grades II–IV) diagnosis with imaging proceders (e.g. x-ray, CT, MRI) not older than 6 month 2) Knee pain for at least 4 weeks and pain intensity NRS =5 3) Treatment initiation with ACS 4) Signed informed written Patient´s Informed Consent Form
Exclusion criteria
Exclusion criteria: 1) Previous knee operations in the last 6 months (Surgery and/or diagnostic arthroscopy) 2) History of clinically significant trauma 3) Intra-articular injections in the last 3 months with steroids, hyaluronate compounds or PRP, ACS, ACP 4) RA or autoimmune cause of arthritis, systemic bone or joint illnesses 5) Active inflammation of predominant patella-femoral disease 6) BMI>30 7) Malignancy 8) Infection 9) Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraindividual comparison of the pain sub scale of the "Knee injury and Osteoarthritis Outcome Score" (KOOS) between week 0 and 48 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Intraindividual comparison of the "Numeric Rating Scale" (NRS) between week 0 and 48 weeks. 2) Intraindividual comparison of the sub-scales of the "Knee injury and Osteoarthritis Outcome Score" (KOOS) between week 0 and 48 weeks. 3) Intraindividual comparison of the "EuroQol five dimensions questionnaire15" (EQ-5D) between week 0 and 48 weeks. 4) Intraindividual comparison of the "Work Productivity and Activity Impairment" (WPAI) between week 0 and 48 weeks. | — |
Countries
Germany, Italy, Poland, Serbia, Spain, Turkey
Contacts
Public ContactTanju Kaptan
ORTHOGEN Lab Services GmbH
Outcome results
None listed