No registrations found.
ID
Source
Brief title
Health condition
Osteoarthritis patients in who total knee replacement is planned
Sponsors and support
Intervention
Outcome measures
Primary outcome
The 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 outcome
Secondary 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.
Study design
6 weeks, 12 weeks and 6 months after surgery
Intervention
Daily 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.
W. Klöpping
Wageningen 6700 AA
The Netherlands
+31 317 484277
ineke.klopping-ketelaars@wur.nl
W. Klöpping
Wageningen 6700 AA
The Netherlands
+31 317 484277
ineke.klopping-ketelaars@wur.nl
Inclusion criteria
Planned for total knee replacement therapy
> 18 years old and mentally competent
Exclusion criteria
Current 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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6290 |
| NTR-old | NTR6464 |
| CCMO | NL58987.081.16 |
| OMON | NL-OMON42856 |