search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


CoKnie


- candidate number27312
- NTR NumberNTR6464
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-mei-2017
- Secondary IDsNL58987.081.16 
- Public TitleCoKnie
- Scientific TitleThe effect of hydrolysed collagen on pain, synovial inflammation and postoperative outcome in patients undergoing total knee replacement therapy
- ACRONYMCoKnie
- hypothesis
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Knee
- Inclusion criteriaPlanned for total knee replacement therapy
> 18 years old and mentally competent
- Exclusion criteriaCurrent use (latest use one week or less before inclusion) of supplements (like glucosamine, chondroitin, green-lipped mussel, curcumin or blackcurrant leaf).
Diagnosed with Rheumatoid Arthritis
Medical history of renal insufficiency (eGRF<60ml)
Daily use of high doses NSAIDs in the 14 days before inclusion: Defined as higher than maintenance dose in the “farmacotherapeutisch kompas”.
Vegetarians
Childbearing potential
Inability to perform the functional tests due to other impairments than the knee that is to be replaced Use of systemic corticosteroids
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2017
- planned closingdate31-mrt-2018
- Target number of participants92
- InterventionsDaily supplementation of hydrolysed collagen (10g) or placebo (maltodextrin; 10g), for a period of 12 weeks. All supplements will be provided as flavoured powder drink products that can be dissolved in water.
- Primary outcomeThe primary objective is to investigate the difference between the two groups in change from baseline in Oxford Knee Scores at 6 weeks after the surgery.
- Secondary outcomeSecondary objectives are to assess the difference between the two groups in change from baseline in Oxford Knee Scores at 12 weeks after the surgery and at 6 months after the surgery.
On pain VAS scores measured at hospital admission, 2 weeks post-surgery, and 6 weeks post-surgery.
On the amount and period of pain relieving therapies, On inflammation in synovial fluid, muscle and knee function, functional tests and clinical outcome parameters.
- Timepoints6 weeks, 12 weeks and 6 months after surgery
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES W. Klöpping
- CONTACT for SCIENTIFIC QUERIES W. Klöpping
- Sponsor/Initiator Wageningen University (WUR)
- Funding
(Source(s) of Monetary or Material Support)
Rousselot
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD23-mei-2017 - 3-jul-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl