Contact information
Type
Scientific
Primary contact
Dr Carsten Moser
ORCID ID
Contact details
Universitaetstrasse 142
Bochum
44799
Germany
+49 (0)234 9780 165
moser@microtherapy.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1004
Study information
Scientific title
Efficacy and safety of autologous conditioned serum (ACS/Orthokine®) compared with Triamcinolone in the treatment of symptomatic hip osteoarthritis. A double-blinded, randomised, controlled, parallel group trial.
Acronym
OrthoCox
Study hypothesis
There are significant differences between intra-articular injections with either autologous conditioned serum (ACS) and Triamcinoone in terms of pain relief or improvement in function or life quality, as determined by validated scoring systems.
Further reading:
1. Meijer H, Reinecke J, Becker C, Tholen G, Wehling P. The production of anti-inflammatory cytokines in whole blood by physico-chemical induction. Inflamm Res. 2003;52(10):404-407.
http://www.ncbi.nlm.nih.giv/pubmed/14520515
2. Wehling P, Moser C, Frisbie DD, McIlwraith CW, Kawcak CE, Krauspe R, Reinecke J. Autologous Conditioned Serum in the treatment of Orthopaedic diseases - The Orthokine Therapy. Biodrugs. 2007;21(5):223-232.
http://www.ncbi.nlm.nih.giv/pubmed/17896838
3. Baltzer AW, Moser C, Jansen SA, Krauspe R. Autologous conditioned serum (Orthokine) is an effective treatment for knee osteoarthritis. Osteoarthritis Cartilage. 2009;17(2):152-160.
http://www.ncbi.nlm.nih.giv/pubmed/18674932
Ethics approval
Not provided at time of registration
Study design
Prospective 2 arm double blind (masked observer) randomised controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
A patient information sheet (PIS) in web format will be available shortly. Until then please use contact details below to request a PIS.
Condition
Osteoarthritis of the hip
Intervention
Study of ultrasound-guided intra-articular injection regimens in the treatment of symptomatic hip osteoarthritis.
Treatment with ACS / Orhtokin® will be given 3 times as a 2ml intraarticular injection. Since it is an individual mixture, there is no set concentration of anti-inflammatory cytokines.
Triamcinolon (10mg) will be injected once. For the second and third visit the Triamcinolon Group will receive intraarticular injections with saline.
The follow ups will be at the end of the last visit, after 3 months and after 6 months.
Intervention type
Drug
Phase
Not Specified
Drug names
Autologous conditioned serum (ACS/Orthokine®)
Primary outcome measures
1. Mean changes from baseline in the global Western Ontario MacMaster Universities Osteoarthritis Index (WOMAC) score
2. Changes in weight-bearing pain using a numeric rating scale (NRS)
All questionnaires will be filled out as a baseline score before the visit, right after the last of three injections, after 3 months and after 6 months.
Secondary outcome measures
1. Success of therapies measured according to the changes from baseline in the different health-related quality-of-life profiles
1.1. SF-12
1.2. Harris Hip Score
1.3. EuroCol-5d
2. The number of adverse events and serious adverse events wil be used to compare the safety profile of the two treatments groups.
All questionnaires will be filled out as a baseline score before the visit, right after the last of three injections, after 3 months and after 6 months.
Overall trial start date
01/03/2010
Overall trial end date
31/12/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age: over 30 years old
2. Chronic hip osteoarthritic (OA) 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 hip joint (Kellgren 2 or 3; Ravaud & Dougados 1997)
4. Signed written informed consent
5. At least pain grade 4 (measured on a numeric rating scale 0-10)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
130
Participant exclusion criteria
1. Pathologies:
1.1. Systemic disease of the musculoskeletal system
1.2. Bone cancer, metastasis or tumour-like lesions in the immediate proximity to the treated joint
1.3. Fracture in the last 3 months
1.4. Acute bacterial infection of the hip to be treated
1.5. Conditions, internal or oncological, which impair the patients general fitness (performance status [PS] >2; New York Heart Association [NYHA] >II)
1.6. Blood clotting disorders
1.7. Osteonecrosis of the hip to be treated
2. Treatment:
2.1. Treatment of the affected hip due to osteoarthritis with one of the two study medications in the last 6 months
2.2. Present psychiatric disease requiring therapy
2.3. Ongoing corticoid or non-steroidal anti-inflammatory drug (NSAID) therapy due to other diseases
3. Other:
3.1. Operation on the affected hip within the last 3 months
3.2. Pregnant or breast-feeding patients
3.3. Drug dependency (alcohol, analgesics, opiates, etc.)
3.4. 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
01/03/2010
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Germany
Trial participating centre
Universitaetstrasse 142
Bochum
44799
Germany
Sponsor information
Organisation
Orthogen AG (Germany)
Sponsor details
Graf-Adolf Strasse 41
Duesseldorf
D-40210
Germany
+49 (0)211 38700700
peter.wehling@orthogen.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Orthogen AG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Clinic and practice for Orthopaedics, Dr. med. Klaus-Dietrich von Bergen (Germany)
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