The Orthokin® trial: a prospective double blind placebo-controlled randomised trial to investigate the effectiveness of autologous interleukin-1 receptor antagonist in the treatment of osteoarthritis (OA)
| ISRCTN | ISRCTN44912979 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44912979 |
| Secondary identifying numbers | NTR202 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 18/11/2008
- 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 N.J.H. Raijmakers
Scientific
Scientific
University Medical Centre Utrecht
Department of Orthopaedics
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 250 6972 |
|---|---|
| n.j.h.raijmakers@chir.azu.nl |
Study information
| Study design | Multicentre, randomised, double-blind, placebo controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 1. Orthokin® relieves symptoms of pain and dysfunction of OA as determined by the outcome of designated subjective scoring systems 2. Orthokin® reduces inflammatory markers in synovial fluid 3. Orthokin® inhibits long-term radiological progression of OA development |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Arthritis, osteoarthritis |
| Intervention | The treatment for the patients in both groups will be identical to ensure that both the patient and the treating surgeon are blinded for the treatment the patient received. The treatment comprises a venapunction to obtain 50 milliliters of blood using the Orthokin® syringe containing the surface treated glass particles. This blood send to the Orthogen laboratory where it is prepared for intra-articular injection. The patients will receive 6 intra-articular injections over a period of 4 weeks, either with Orthokin® or with a placebo. Before administration of the treatment, the synovial fluid present in the treated joints will be collected to prevent dilution of the drug and for measurement of the concentrations of various inflammatory cytokines by multiplex ELISA (Biorad®). Before and 3, 6, 9 and 12 months after the initiation of the treatment, the patients will be asked to fill out a questionnaire (containing a VAS for pain, the Knee injury and Osteoarthritis Outcome Scale (KOOS) and the 100-point knee society clinical rating scale) to evaluate the effectiveness of the treatment. At these time-points the patients will also be asked to return to the outpatient clinic for objective evaluation of the effectiveness of the treatment by their treating surgeon. 12 months after initiation of the treatment is the primary endpoint of this study as the effectiveness of the treatment with respect to the symptomatology of OA will than be evaluated. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Orthokin® |
| Primary outcome measure | Questionnaires |
| Secondary outcome measures | X-rays |
| Overall study start date | 27/01/2004 |
| Completion date | 01/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 182 |
| Key inclusion criteria | 1. Typical symptoms for osteoarthritis as judged by the physician 2. Previous treatment more than 6 months ago 3. Patient signed informed consent 4. Patient greater than 18 years old 5. Minimal 40 mm Visual Analogue Scale (VAS) pain 6. Maximal 60 points Knee Society Rating Scale 7. Maximal 60 points KOOS index |
| Key exclusion criteria | 1. Participation in concurrent trials 2. Participation in previous trials within 3 months 3. Patient know to have human immunodeficiency virus (HIV), hepatitis, cytomegalovirus (CMV) and syphilis infections 4. Alcohol and drug abuse 5. Poor general health condition as judged by the treating physician 6. Received hyaluronic acid and/or corticosteroid intra-articular injections into the afflicted knee within the last 6 months of baseline 7. Intake of specific drugs, such as chondroitin sulfate, diacerein, n-glucosamine, piacledine, capsain within 2 weeks of the baseline visit 8. Any concomitant painful or disabling disease of the spine, the hips or lower limbs that would interfere with evaluation of the afflicted knee 9. Ipsilateral coxarhrosis and hip prothesis loosening 10. Any clinically significant or symptomatic vascular or neurological disorder of the lower extremities 11. All crystalline, inflammatory and infectious arthropathies 12. Current diagnosis of osteomyelitis 13. OA grade IV 14. Known immunodeficiency 15. Corticosteroid usage 16. Anti-coagulant usage and coagulopathy 17. Morbid obesity |
| Date of first enrolment | 27/01/2004 |
| Date of final enrolment | 01/09/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (Netherlands)
University/education
University/education
PO Box 85500
Utrecht
3508 GA
Netherlands
| Website | http://www.umcutrecht.nl/zorg/ |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Industry
Somas Chirurgische Techniek BV (The Netherlands)
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 |
