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
Organizational Data
- DRKS-ID:
- DRKS00010478
- Recruitment Status:
- Recruiting withdrawn (before recruiting started)
- Date of registration in DRKS:
- 2016-11-14
- Last update in DRKS:
- 2024-04-08
- Registration type:
- Prospective
Acronym/abbreviation of the study
OrthoR
URL of the study
No Entry
Brief summary in lay language
The influence of a cell-free autologous conditioned serum (ACS) will be investigated on the processes of osteoarthritis of the knee. Autolog conditioned serum is a special serum which is obtained from the own blood of the respective patient. This serum contains a significantly higher concentration of anti-inflammatory substances and various growth factors, as conventional, obtained from whole blood serum.
Brief summary in scientific language
In this study safety and effectiveness of cell-free autologous conditioned serum (ACS) will be investigated in daily routine in a wide population (1000 patients) with knee osteoarthritis (OA) (Kellgren-Lawrence Grades II–IV). Safety and effectiveness of cell-free ACS will be investigated over 3 years.
Health condition or problem studied
- ICD10:
- M17.0 - Primary gonarthrosis, bilateral
- ICD10:
- M17.1 - Other primary gonarthrosis
- ICD10:
- M17.4 - Other secondary gonarthrosis, bilateral
- ICD10:
- M17.5 - Other secondary gonarthrosis
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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.
Endpoints
- Primary outcome:
- Intraindividual comparison of the pain sub scale of the "Knee injury and Osteoarthritis Outcome Score" (KOOS) between week 0 and 48 weeks.
- Secondary outcome:
- 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.
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting withdrawn (before recruiting started)
- Reason if recruiting stopped or withdrawn:
- Leading staff member change
Recruitment Locations
- Recruitment countries:
-
- Germany
- Italy
- Poland
- Serbia
- Spain
- Turkey
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Grönemeyer Institut für MikroTherapie Bochum
Recruitment period and number of participants
- Planned study start date:
- 2018-05-02
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 1000
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 30 Years
- Maximum Age:
- 80 Years
- Additional 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
Addresses
Primary Sponsor
- Address:
- ORTHOGEN AG40212 DüsseldorfGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- ORTHOGEN Lab Services GmbHDr. med. Tanju KaptanErnst-Schneider-Platz 140212 DüsseldorfGermany
- Telephone:
- + 49 211 38700 700
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- ORTHOGEN Lab Services GmbHDr. med. Tanju KaptanErnst-Schneider-Platz 140212 DüsseldorfGermany
- Telephone:
- + 49 211 38700 700
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- ORTHOGEN Lab Services GmbHDr. med. Tanju KaptanErnst-Schneider-Platz 140212 DüsseldorfGermany
- Telephone:
- + 49 211 38700 700
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Orthogen AG40212 DüsseldorfGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Freiburger Ethik-Kommission internationalMozartstr. 2179104 FreiburgGermany
- Telephone:
- +49 761 32007
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2016-08-25
- Ethics committee number:
- 016/1609
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2016-10-10
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry