Condition category
Musculoskeletal Diseases
Date applied
07/02/2010
Date assigned
08/03/2010
Last edited
08/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 patient’s 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

http://www.orthogen.com

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

Publication citations

Additional files

Editorial Notes