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 |
| Secondary identifying numbers | Version 1004 |
- 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
Scientific
Universitaetstrasse 142
Bochum
44799
Germany
| Phone | +49 (0)234 9780 165 |
|---|---|
| moser@microtherapy.de |
Study information
| Study design | Prospective 2 arm double blind (masked observer) randomised controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant 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. |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Autologous conditioned serum (ACS/Orthokine®) |
| Primary outcome measure | 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 study start date | 01/03/2010 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
44799
Germany
Sponsor information
Orthogen AG (Germany)
Industry
Industry
Graf-Adolf Strasse 41
Duesseldorf
D-40210
Germany
| Phone | +49 (0)211 38700700 |
|---|---|
| peter.wehling@orthogen.com | |
| Website | http://www.orthogen.com |
"ROR" |
https://ror.org/01qwfvp91 |
Funders
Funder type
Industry
Orthogen AG (Germany)
No information available
Clinic and practice for Orthopaedics, Dr. med. Klaus-Dietrich von Bergen (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
