Autologous conditioned serum (Orthokine®) compared with hyaluronic acid and placebo injections for the treatment of osteoarthritis. A prospective, randomized, placebo-controlled, double-blind, parallel-design, multicenter trial.

ISRCTN ISRCTN71311752
DOI https://doi.org/10.1186/ISRCTN71311752
Secondary identifying numbers 1
Submission date
13/09/2005
Registration date
19/10/2005
Last edited
21/03/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Axel WA Baltzer
Scientific

Koenigsallee 53-55
Duesseldorf
40212
Germany

Phone +49 (0)211 828 93710
Email axel.baltzer@gmx.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designMulti-centre
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymOrthokine Osteoarthritis Trial
Study objectivesWe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOsteoarthitis of the knee.
InterventionTo 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Autologous conditioned serum (Orthokine®), hyaluronic acid
Primary outcome measureThe 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 measuresSecondary 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 study start date01/10/2003
Completion date01/10/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants400
Key inclusion criteria1. 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)
Key exclusion criteriaPathologies:
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)
Date of first enrolment01/10/2003
Date of final enrolment01/10/2005

Locations

Countries of recruitment

  • Germany

Study participating centre

Koenigsallee 53-55
Duesseldorf
40212
Germany

Sponsor information

Orthogen (Germany)
Industry

Graf Adolf Strasse 43
Duesseldorf
40210
Germany

Phone +49 (0)211 387 0074
Email carsten.moser@orthogen.com
Website http://www.orthogen.com
ROR logo "ROR" https://ror.org/01qwfvp91

Funders

Funder type

Hospital/treatment centre

Department of Orthopedics, University Hospital Düsseldorf

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/06/2003 Yes No
Results article results 01/10/2003 Yes No
Results article results 01/02/2009 Yes No