Condition category
Musculoskeletal Diseases
Date applied
13/09/2005
Date assigned
19/10/2005
Last edited
21/03/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 patient’s 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

http://www.orthogen.com

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

  1. 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.

Additional files

Editorial Notes