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The effect of hydrolysed COllagen (Peptan®) on pain, synovial inflammation and postoperative outcome in patients undergoing total KNee replacement therapy

The effect of hydrolysed COllagen (Peptan®) on pain, synovial inflammation and postoperative outcome in patients undergoing total KNee replacement therapy - CoKnee

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42856
Enrollment
92
Registered
2017-03-02
Start date
2017-06-08
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoarthritis damaged knee and knee replacement

Interventions

To receive daily either Peptan® or placebo (maltodextrin) supplement for 12 weeks.

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Planned for total knee replacement therapy • > 18 years old and mentally competent

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)