Contact information
Type
Scientific
Primary contact
Mr Axel WA Baltzer
ORCID ID
Contact details
Koenigsallee 53-55
Duesseldorf
40212
Germany
+49 (0)211 828 93710
axel.baltzer@gmx.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Acronym
Orthokine Osteoarthritis Trial
Study hypothesis
We tested the hypothesis that there are no significant differences between intra-articular injections with either autologous conditioned serum (ACS), hyaluronic acid (HA) and placebo in terms of pain relief or improvement in function or life quality, as determined by validated scoring systems.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Osteoarthitis of the knee.
Intervention
To compare the efficiacy and safety of intra-articular injections of ACS (Orthokine®), HA (Hya-Ject®) and placebo (saline) in patients with unilateral knee osteoarthritis.
Intervention type
Drug
Phase
Not Specified
Drug names
Autologous conditioned serum (Orthokine®), hyaluronic acid
Primary outcome measures
The primary efficacy parameters were the mean changes from baseline in the global Western Ontario MacMaster (WOMAC) score, weight-bearing pain using a visual analogue pain scale (VAS) and global patient assessment (GPA) at weeks 13 and 26.
Secondary outcome measures
Secondary endpoints were the success of therapies measured according to the changes in the different health-related quality-of-life profiles in the SF-8 with regard to baseline scores during the 26 weeks, the changes in the global patient assessment after 7 and 13 weeks and changes on the WOMAC score and the VAS pain score after 7 weeks. In addition the number of adverse events and serious adverse events was used to compare the safety profile of the three treatments groups.
Overall trial start date
01/10/2003
Overall trial end date
01/10/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age: over 30 years old
2. Chronic knee pain for at least 3 months measured according to American College of Rheumatology (ACR) criteria (Altman, Asch, et al. 1986)
3. X-ray signs of uni- or bi-lateral osteoarthritis of the knee joint (Kellgren 2 or 3; Ravaud & Dougados 1997)
4. Signed written informed consent
5. At least pain grade 5 (measured on a visual analogue pain scale 0-10)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
Pathologies:
1. Systemic disease of the musculoskeletal system
2. Bone cancer, metastasis or tumor-like lesions in the immediate proximity to the treated joint
3. Fracture in the last 3 months
4. Acute bacterial infection of the knee to be treated
5. Conditions, internal or oncological, which impair the patients general fitness (performance status [PS] >2; New York Heart Association [NYHA] >II)
6. Blood clotting disorders
7. Osteonecrosis of the knee to be treated
Treatment:
1. Treatment of the affected knee due to osteoarthritis with one of the three study medications in the last 6 months
2. Present psychiatric disease requiring therapy
3. Ongoing corticoid therapy
Other:
1. Operation on the affected knee within the last 3 months
2. Pregnant or breast-feeding patients
3. Drug dependency (alcohol, analgesics, opiates, etc.)
4. Lack of mental ability to understand the study procedures due to lack of optimal communication capacity (knowledge of the language, dementia, lack of time)
Recruitment start date
01/10/2003
Recruitment end date
01/10/2005
Locations
Countries of recruitment
Germany
Trial participating centre
Koenigsallee 53-55
Duesseldorf
40212
Germany
Sponsor information
Organisation
Orthogen (Germany)
Sponsor details
Graf Adolf Strasse 43
Duesseldorf
40210
Germany
+49 (0)211 387 0074
carsten.moser@orthogen.com
Sponsor type
Industry
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Department of Orthopedics, University Hospital Düsseldorf
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. Meijer H, et al.: The production of anti-inflammatory cytokines in whole blood by physico-chemical induction. Inflamm Res 2003, 52(10):404-407.
2. Baltzer AWA, et al.: Intraartikuläre Therapie der Gonarthrose mit autologen Interleukin 1 Rezeptorantagonisten (IL-1Ra). Deut Zeitschrift für Sportmedizin 2003, 54(6):209-211.
3. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18674932
Publication citations
-
Results
Baltzer AW, Moser C, Jansen SA, Krauspe R, Autologous conditioned serum (Orthokine) is an effective treatment for knee osteoarthritis., Osteoarthr. Cartil., 2009, 17, 2, 152-160, doi: 10.1016/j.joca.2008.06.014.