Selective COX-2 inhibition is beneficial for matrix turnover.
ID
Bron
Verkorte titel
Aandoening
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).
Ondersteuning
Rheumatology & Clin. Immunology
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Difference in proteoglycan release of osteoarthritic cartilage after treatment.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Selective COX-2 inhibition is beneficial for matrix turnover.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Publiek
P.O. Box 85500
A.C.A. Marijnissen
Utrecht 3508 GA
The Netherlands
+31 (0)30 2509758
a.c.a.marijnissen@umcutrecht.nl
Wetenschappelijk
P.O. Box 85500
A.C.A. Marijnissen
Utrecht 3508 GA
The Netherlands
+31 (0)30 2509758
a.c.a.marijnissen@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients with knee osteoarthritis according to the ACR criteria, considered for total knee replacement surgery.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL126 |
| NTR-old | NTR159 |
| Ander register | : N/A |
| ISRCTN | ISRCTN90366351 |