Condition category
Musculoskeletal Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
18/11/2008
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 N.J.H. Raijmakers

ORCID ID

Contact details

University Medical Centre Utrecht
Department of Orthopaedics
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 250 6972
n.j.h.raijmakers@chir.azu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR202

Study information

Scientific title

Acronym

Study hypothesis

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

Received from the local medical ethics committee

Study design

Multicentre, randomised, double-blind, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Orthokin®

Primary outcome measures

Questionnaires

Secondary outcome measures

X-rays

Overall trial start date

27/01/2004

Overall trial end date

01/09/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

182

Participant 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

Recruitment start date

27/01/2004

Recruitment end date

01/09/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Industry

Funder name

Somas Chirurgische Techniek BV (The Netherlands)

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