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ISRCTN
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ISRCTN71311752
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ClinicalTrials.gov identifier
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Public title
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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.
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Scientific title
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Acronym
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Orthokine Osteoarthritis Trial
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Serial number at source
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1
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Osteoarthitis of the knee.
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Participants - inclusion criteria
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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)
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Participants - exclusion criteria
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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)
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Anticipated start date
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01/10/2003
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Anticipated end date
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01/10/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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400
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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Department of Orthopedics, University Hospital Düsseldorf
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Trial website
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Publications
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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.
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Contact name
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Mr
Axel WA
Baltzer
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Address
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Koenigsallee 53-55
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City/town
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Duesseldorf
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Zip/Postcode
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40212
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Country
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Germany
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Tel
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+49 (0)211 828 93710
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Fax
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+49 (0)211 828 93711
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Email
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axel.baltzer@gmx.de
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Sponsor
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Orthogen (Germany)
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Address
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Graf Adolf Strasse 43
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City/town
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Duesseldorf
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Zip/Postcode
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40210
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Country
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Germany
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Tel
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+49 (0)211 387 0074
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Fax
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+49 (0)211 387 0010
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Email
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carsten.moser@orthogen.com
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Sponsor website:
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http://www.orthogen.com
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Date applied
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13/09/2005
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Last edited
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29/09/2006
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Date ISRCTN assigned
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19/10/2005
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