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.
| ISRCTN | ISRCTN71311752 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71311752 |
| Protocol serial number | 1 |
| Sponsor | Orthogen (Germany) |
| Funder | Department of Orthopedics, University Hospital Düsseldorf |
- Submission date
- 13/09/2005
- Registration date
- 19/10/2005
- Last edited
- 21/03/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Axel WA Baltzer
Scientific
Scientific
Koenigsallee 53-55
Duesseldorf
40212
Germany
| Phone | +49 (0)211 828 93710 |
|---|---|
| axel.baltzer@gmx.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Multi-centre |
| Scientific title | |
| Study acronym | Orthokine Osteoarthritis Trial |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Osteoarthitis of the knee. |
| Intervention | 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. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Autologous conditioned serum (Orthokine®), hyaluronic acid |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 01/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 400 |
| Key inclusion criteria | 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) |
| Key exclusion criteria | 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 patients 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) |
| Date of first enrolment | 01/10/2003 |
| Date of final enrolment | 01/10/2005 |
Locations
Countries of recruitment
- Germany
Study participating centre
Koenigsallee 53-55
Duesseldorf
40212
Germany
40212
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? |
|---|---|---|---|---|---|
| Results article | 01/06/2003 | Yes | No | ||
| Results article | results | 01/10/2003 | Yes | No | |
| Results article | results | 01/02/2009 | Yes | No |
