Efficacy and safety of autologous conditioned serum (ACS/Orthokine®) compared with Triamcinolone in the treatment of symptomatic hip osteoarthritis.

ISRCTN	ISRCTN16719506
DOI	https://doi.org/10.1186/ISRCTN16719506
Protocol serial number	Version 1004
Sponsor	Orthogen AG (Germany)
Funders	Orthogen AG (Germany), Clinic and practice for Orthopaedics, Dr. med. Klaus-Dietrich von Bergen (Germany)

Submission date: 07/02/2010
Registration date: 08/03/2010
Last edited: 08/03/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Carsten Moser
Scientific

Universitaetstrasse 142
Bochum
44799
Germany

Phone	+49 (0)234 9780 165
Email	moser@microtherapy.de

Study information

Primary study design	Interventional
Study design	Prospective 2 arm double blind (masked observer) randomised controlled parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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.
Study acronym	OrthoCox
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Autologous conditioned serum (ACS/Orthokine®)
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	130
Key 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)
Key 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)
Date of first enrolment	01/03/2010
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

Germany

Study participating centre

Universitaetstrasse 142

Bochum
44799
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes