In this study we would like to investigate the effect of CP (Peptan®) on pain, synovial inflammation and functional and clinical outcome parameters in patients undergoing total knee replacement therapy.
ID
Source
Brief title
Condition
- Other condition
- Bone and joint therapeutic procedures
Synonym
Health condition
osteoarthritis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to investigate the effect of collagen peptides
(Peptan®) on pain and knee function in patients undergoing total knee
replacement therapy.
Secondary outcome
Secondary objectives are to assess the effect of collagen peptides (Peptan®)
on the amount and period of pain reducing therapies,
synovial inflammation, wound healing,
muscle and knee function, mobiliteit
clinical outcome parameters (e.g. PROMS) in patients undergoing total knee
arthroplasty
Background summary
Patients undergoing knee surgery often suffer from pain and discomfort during
the days after surgery. Pain and discomfort can be influenced by inflammation
in the knee and /or by decreased muscle function. Collagen peptides may reduce
pain in patients and stabilize muscle function in patients, thereby improving
clinical outcome and well-being of patients.
Study objective
In this study we would like to investigate the effect of CP (Peptan®) on pain,
synovial inflammation and functional and clinical outcome parameters in
patients undergoing total knee replacement therapy.
Study design
This is a double-blind randomized placebo-controlled trial.
Intervention
To receive daily either Peptan® or placebo (maltodextrin) supplement for 12
weeks.
Study burden and risks
This study will provide more information about the clinical effects of Peptan®
compared to placebo on pain and pain reducing therapies. This information is
valuable since reduction in NSAIDs and other pain killers in this population
would be worthwhile. No adverse effects of peptan® or placebo are expected. The
study has been designed to blend as much as possible with standard clinical
care.
Based on these considerations, to our opinion, the risks for the participants
are negligible, and do not outweigh the scientific relevance of this study
Stippeneng 4
Wageningen 6708 WE
NL
Stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
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 anti-inflammatory supplements (like glucosamine, chondroitin, green-lipped mussel, curcumin or blackcurrant leaf).
• Diagnosed with Rheumatoid Arthritis
• Medical history of renal insufficiency
• Daily use of high doses NSAIDs in the 14 days before inclusion:
Defined as higher than maintenance dose (in the "farmacotherapeutisch kompas")
for example: acetylsalicylic acid > 4 g /day; diclofenac > 75 mg/day; naproxen > 500 mg/day; ibuprofen> 1600 mg /day; celecoxib >200 mg/day
Use of systemic corticosteroids
• Vegetarians
• Childbearing potential
• Inability to perform the functional tests due to other impairments than the knee that is to be replaced
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL58987.081.16 |
| OMON | NL-OMON27720 |