No registrations found.
ID
Source
Brief title
Health condition
Osteoarthritis of the knee is a progressing degenerative joint disorder, characterised by joint pain and limitation of movement, leading to disability. Tissue changes comprise damage of joint cartilage, synovial inflammation and changes in subchondral bone, such as subchondral sclerosis and osteophyte formation (bony outgrowths).
Sponsors and support
Rheumatology & Clin. Immunology
Intervention
Outcome measures
Primary outcome
Difference in proteoglycan release of osteoarthritic cartilage after treatment.
Secondary outcome
ProsteoglandinE2 levels produced by cartilage.
Background summary
Objectives:
Selective COX-2 inhibitors are prescribed for many disorders including osteoarthritis (OA), a degenerative joint disease with an incidence exceeding 10% of the adult population.
Recent in vitro studies showed a positive direct effect of celecoxib, one of the selective COX-2 inhibitors, on human OA cartilage. Such effects are difficult to verify in a clinical trial because changes in OA cartilage, degenerative and reparative, are slow and evaluation of articular cartilage by imaging techniques is still hampered by their limited sensitivity.
Therefore, an approach is used in which the benefits of in vivo treatment are combined with the benefits of ex vivo biochemical analyses of the cartilage.
Methods:
Patients with knee OA are treated 4 weeks prior to scheduled knee replacement surgery with celecoxib 2dd200mg, naproxen 3dd250mg, or indomethacin 2dd50mg. During surgery cartilage is collected and analyzed ex vivo.
Study objective
Selective COX-2 inhibition is beneficial for matrix turnover.
Study design
N/A
Intervention
Celecoxib: 4 weeks, 2 times per day, 200 mg;
Naproxen: 4 weeks, 3 times per day, 250 mg;
Indomethacin: 4 weeks, 2 times per day, 50 mg.
P.O. Box 85500
A.C.A. Marijnissen
Utrecht 3508 GA
The Netherlands
+31 (0)30 2509758
a.c.a.marijnissen@umcutrecht.nl
P.O. Box 85500
A.C.A. Marijnissen
Utrecht 3508 GA
The Netherlands
+31 (0)30 2509758
a.c.a.marijnissen@umcutrecht.nl
Inclusion criteria
Patients with knee osteoarthritis according to the ACR criteria, considered for total knee replacement surgery.
Exclusion criteria
1. Total knee replacement for other reason than osteoarthritis;
2. History of gastro-intestinal bleedings or perforation;
3. Increased risk for cardiovascular diseases (cardiovascular diseases in history, patients with untreated hypertension, patients with angina pectoris, and patients on oral anticoagulantia).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL126 |
| NTR-old | NTR159 |
| Other | : N/A |
| ISRCTN | ISRCTN90366351 |