Prospective, open, multicentre observational clinical study to inves- tigate safety and efficacy of cell-free Autologous Conditioned Serum (ACS) in patients with knee osteoarthritis with 3 years follow-up

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00010478
• Date of registration: 14/11/2016
• Prospective Registration: Yes
• Primary sponsor: ORTHOGEN AG
• Public title: Prospective, open, multicentre observational clinical study to inves- tigate safety and efficacy of cell-free Autologous Conditioned Serum (ACS) in patients with knee osteoarthritis with 3 years follow-up
• Scientific title: Prospective, open, multicentre observational clinical study to inves- tigate safety and efficacy of cell-free Autologous Conditioned Serum (ACS) in patients with knee osteoarthritis with 3 years follow-up - OrthoR
• Date of first enrolment: 02/05/2018
• Target sample size: 1000
• Recruitment status: Recruiting withdrawn before recruiting started
• URL: http://drks.de/search/en/trial/DRKS00010478
• Study type: observational
• Study design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment

Countries of recruitment

Germany, Italy, Poland, Serbia, Spain, Turkey

Contacts

• Name: Tanju Kaptan
• Affiliation: ORTHOGEN Lab Services GmbH

• Name: Tanju Kaptan
• Affiliation: ORTHOGEN Lab Services GmbH

Key inclusion & exclusion 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: 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


Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

M17.0
M17.1
M17.4
M17.5

M17.1

Other secondary gonarthrosis, bilateral

Primary gonarthrosis, bilateral

M17.0

Other primary gonarthrosis

M17.4

M17.5

Other secondary gonarthrosis

Intervention(s)

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 within two weeks.

Primary Outcome(s)

Intraindividual comparison of the pain sub scale of the "Knee injury and Osteoarthritis Outcome Score" (KOOS) between week 0 and 48 weeks.

Secondary Outcome(s)

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.

Source(s) of Monetary Support

Orthogen AG

Ethics review

Status: Approved
Approval date: 10/10/2016
Contact:

Results

• URL: http://drks.de/search/en/trial/DRKS00010478#studyResults